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Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (CLIPPER2)

Primary Purpose

Juvenile Idiopahtic Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
etanercept
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopahtic Arthritis focused on measuring Use of etanercept to treat pediatric subjects with extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA).

Eligibility Criteria

2 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)

Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Exclusion criteria for subject planning to continue investigational product:

withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).

History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.

Sites / Locations

  • The Children's Hospital at Westmead
  • Royal Children's Hospital
  • Cliniques Universitaires Saint Luc
  • Universitair Ziekenhuis Gent
  • Servimed S.A.S
  • Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie
  • Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze
  • Revmatologicky ustav
  • Hopital Cochin
  • Hopital NECKER-Enfants Malades
  • HELIOS Klinikum Berlin-Buch
  • Klinikum Bremen-Mitte
  • Schön Klinik Hamburg Eilbek
  • Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie
  • Semmelweis Egyetem
  • Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"
  • University Children Hospital Gailezers
  • University Children Hospital
  • Children's Hospital at Vilnius University Hospital "Santaros klinikos"
  • CLIDITER S.A. de C.V.
  • Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063
  • Depart. of Rheumatology
  • Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
  • Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i
  • Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny
  • FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy
  • SBEI HPE Saint Petersburg State Pediatric Medical University
  • Institute of Rheumatology
  • Children's Clinic of Internal Medicine
  • Narodny ustav reumatickych chorob
  • University Medical Centre Ljubljana, University Children's Hospital
  • Hospital San Juan de Dios
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitari i Politecnic La Fe de Valencia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Malignancy: All Periods of Parent and Extension Study
Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

Secondary Outcome Measures

Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants With Serious Infections: All Periods of Parent and Extension Study
Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.
Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study
Medically important infections were defined as an infection requiring parenteral (intravenous [IV], intramuscular [IM]) anti-infective agent(s) and/or hospitalization.
Number of Participants With Infections: All Periods of Parent and Extension Study
Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study
Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants With Infections: Extension Study: Withdrawal Period
Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study
Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (>) 0 a greater mean, and less than (<0) a lesser mean than the standard.
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
ACR50PR:>=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants >18 years assessed using CHAQ.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period
PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (<=) 15 minutes.
Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility.
Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% [10 palms], upper extremities= 20% [20 palms], Trunk [axillae and groin]= 30% [30 palms], lower extremities [buttocks]= 40% [40 palms]). The total BSA affected was the summation of individual regions affected.
Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
All Cause Mortality: All Periods of Extension Study
The considered event was death due to any cause from baseline to the end of the study.
Number of Participants With Prior Non-study Medication: All Periods of Extension Study
Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.
Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study
Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.
Number of Participants With After Non-study Medication: All Periods of Extension Study
After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.
Exposure Time: Extension Study: Active Treatment Period
The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.
Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period
Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.

Full Information

First Posted
August 18, 2011
Last Updated
April 6, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01421069
Brief Title
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Acronym
CLIPPER2
Official Title
AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2011 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopahtic Arthritis
Keywords
Use of etanercept to treat pediatric subjects with extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA).

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
etanercept
Intervention Description
Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW). Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW.
Primary Outcome Measure Information:
Title
Number of Participants With Malignancy: All Periods of Parent and Extension Study
Description
Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study
Description
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Title
Number of Participants With Serious Infections: All Periods of Parent and Extension Study
Description
Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Title
Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study
Description
Medically important infections were defined as an infection requiring parenteral (intravenous [IV], intramuscular [IM]) anti-infective agent(s) and/or hospitalization.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Title
Number of Participants With Infections: All Periods of Parent and Extension Study
Description
Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Title
Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study
Description
Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Title
Number of Participants With Infections: Extension Study: Withdrawal Period
Description
Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Title
Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study
Description
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)
Title
Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period
Description
Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
Time Frame
Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)
Title
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study
Description
Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.
Time Frame
Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)
Title
Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Description
Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (>) 0 a greater mean, and less than (<0) a lesser mean than the standard.
Time Frame
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Title
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Description
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Time Frame
Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study
Title
Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Description
Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard.
Time Frame
Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period
Description
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Time Frame
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Title
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period
Description
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Time Frame
Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study
Title
Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period
Description
Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.
Time Frame
Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period
Description
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Description
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:
Description
ACR30PR: >=30% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Description
ACR50PR: >=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Description
ACR50PR:>=50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants >18 years assessed using CHAQ.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Description
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Description
ACR70PR: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period
Description
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period
Description
ACR90PR: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 [no disease activity] to 10 [maximum disease activity],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 [very well] to 10 [very poor],higher score=higher pain), childhood health assessment questionnaire ([CHAQ] Participants >18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 [no difficulty] to 3 [unable to do]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 [no difficulty] to 3 [extreme difficulty], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period
Description
PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Time Frame
Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; > 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (<=) 15 minutes.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Time Frame
Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of <=15 minutes.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period
Description
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period
Description
JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.
Time Frame
Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Description
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Description
Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study
Title
Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Description
Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Description
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)
Description
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study
Title
Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)
Description
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.
Time Frame
Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study
Title
Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility.
Time Frame
Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
Description
Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% [10 palms], upper extremities= 20% [20 palms], Trunk [axillae and groin]= 30% [30 palms], lower extremities [buttocks]= 40% [40 palms]). The total BSA affected was the summation of individual regions affected.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)
Description
PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
Time Frame
Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
All Cause Mortality: All Periods of Extension Study
Description
The considered event was death due to any cause from baseline to the end of the study.
Time Frame
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Title
Number of Participants With Prior Non-study Medication: All Periods of Extension Study
Description
Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.
Time Frame
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Title
Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study
Description
Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.
Time Frame
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Title
Number of Participants With After Non-study Medication: All Periods of Extension Study
Description
After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.
Time Frame
Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)
Title
Exposure Time: Extension Study: Active Treatment Period
Description
The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.
Time Frame
Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)
Title
Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period
Description
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.
Time Frame
Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study
Title
Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period
Description
Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.
Time Frame
Month 96 active treatment period of extension study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014) Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study. Exclusion Criteria: Exclusion criteria for subject planning to continue investigational product: withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety). History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Children's Hospital at Westmead
City
Westmead, Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville, Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Servimed S.A.S
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie
City
Brno
ZIP/Postal Code
61300
Country
Czechia
Facility Name
Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze
City
Praha 2
ZIP/Postal Code
121 00
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital NECKER-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Schön Klinik Hamburg Eilbek
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie
City
Saint Augustin
ZIP/Postal Code
53757
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
University Children Hospital Gailezers
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Facility Name
University Children Hospital
City
Riga
ZIP/Postal Code
LV1004
Country
Latvia
Facility Name
Children's Hospital at Vilnius University Hospital "Santaros klinikos"
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
CLIDITER S.A. de C.V.
City
Mexico
State/Province
D.f.
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063
City
Utrecht
ZIP/Postal Code
3584 EA
Country
Netherlands
Facility Name
Depart. of Rheumatology
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
City
Bydgoszcz
ZIP/Postal Code
85-667
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Facility Name
Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny
City
Wroclaw
ZIP/Postal Code
52-114
Country
Poland
Facility Name
FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
SBEI HPE Saint Petersburg State Pediatric Medical University
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Children's Clinic of Internal Medicine
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
University Medical Centre Ljubljana, University Children's Hospital
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital San Juan de Dios
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
31122296
Citation
Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801023&StudyName=Extension%20Study%20Evaluating%20Etanercept%20in%203%20Subtypes%20of%20Childhood%20Arthritis%0A
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

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