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Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Phase 1: Etanercept
Phase 1: Methotrexate
Phase 2: Optional ETN, SSZ, HCQ, MTX
Phase 1: Methotrexate
Phase 1: Conventiaonal DMARD
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring enbrel, moderate arthritis, severe arthritis, rheumatoid arthritis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis (RA)
  • Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
  • Active Rheumatoid Arthritis (RA) at time of screening and baseline

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
  • Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
  • Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening

Sites / Locations

  • Consultorios Especializados en Investigaciones Medicas
  • CER San Juan
  • Instituto CAICI
  • OMI
  • Centro de Investigaciones en Enfermedades Reumaticas
  • Hospital Britanico
  • Atencion Integral en Reumatologia
  • Investigaciones Reumatológicas y Osteológicas
  • Centro de Osteopatías Médicas
  • Sanatorio Mayo
  • Hospital Escuela Gral. San Martin
  • Centro Medico Privado de Reumatologia
  • Centro de Investigaciones Reumatologicas
  • Dr Miranda Private Practice
  • Hospital del Salvador
  • Reumalab
  • Centro de Reumatologia y Ortopedia
  • IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1
  • IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2
  • Centro Integral de Reumatologia e Inmunologia LTDA
  • Foqus Ips Ltda
  • Fundacion Instituto de Reumatologia Fernando Chalem
  • Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion
  • Preventive Care Ltda
  • Centro Medico Carlos Ardila Lulle
  • Servimed EU
  • Hospital Angeles Chapalita
  • Centro de Especialidades Medicas del Sureste SA de CV
  • Centro de Investigación y Biomedicina de Chihuahua
  • Hospital Christus Mugerza
  • Hospital Christus Muguerza del Parque
  • Centro de Infusion Marbella
  • Centro de Investigacion Marbella

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phase 1 Etanercept + methotrexate

Phase 1 Conventional DMARD (SSZ or HCQ) + MTX

Arm Description

Phase 1: Etanercept + methotrexate

Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).

Secondary Outcome Measures

Change From Baseline in HAQ Score at Week 24
HAQ: 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 score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. 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; more than 1: significant functional limitation.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Summary of Changes in Therapy at the Beginning of Phase 2
The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.
Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: DAS-value ≤3.7 and DAS-improvement from Baseline >0.6 DAS-value >3.7 and DAS-improvement from Baseline >1.2
Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: DAS-value ≤3.7 and DAS-improvement from Baseline >0.6 DAS-value >3.7 and DAS-improvement from Baseline >1.2
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6 DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6 DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Erosion Score Using vdH mTSS at Week 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.

Full Information

First Posted
February 18, 2009
Last Updated
December 11, 2015
Sponsor
Pfizer
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00848354
Brief Title
Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
Official Title
A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
enbrel, moderate arthritis, severe arthritis, rheumatoid arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Etanercept + methotrexate
Arm Type
Experimental
Arm Description
Phase 1: Etanercept + methotrexate
Arm Title
Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
Arm Type
Active Comparator
Arm Description
Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
Intervention Type
Biological
Intervention Name(s)
Phase 1: Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
Intervention Type
Drug
Intervention Name(s)
Phase 1: Methotrexate
Intervention Description
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Intervention Type
Drug
Intervention Name(s)
Phase 2: Optional ETN, SSZ, HCQ, MTX
Intervention Description
Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.
Intervention Type
Drug
Intervention Name(s)
Phase 1: Methotrexate
Intervention Description
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Intervention Type
Drug
Intervention Name(s)
Phase 1: Conventiaonal DMARD
Intervention Description
Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
Description
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in HAQ Score at Week 24
Description
HAQ: 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 score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. 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; more than 1: significant functional limitation.
Time Frame
Baseline and Week 24
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24
Description
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Summary of Changes in Therapy at the Beginning of Phase 2
Description
The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.
Time Frame
Week 24
Title
Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Description
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Title
Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 24
Title
Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 24
Title
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: DAS-value ≤3.7 and DAS-improvement from Baseline >0.6 DAS-value >3.7 and DAS-improvement from Baseline >1.2
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: DAS-value ≤3.7 and DAS-improvement from Baseline >0.6 DAS-value >3.7 and DAS-improvement from Baseline >1.2
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6 DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6 DAS28-value >5.1 and DAS28-improvement from Baseline >1.2
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Description
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Week 24
Title
Change From Baseline in Erosion Score Using vdH mTSS at Week 24
Description
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time Frame
Week 24
Title
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Description
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Time Frame
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Title
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Description
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.
Time Frame
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 50, Week 76, Week 102, and Week 128
Title
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 50, Week 76, Week 102, and Week 128
Title
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 50, Week 76, Week 102, and Week 128
Title
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24
Title
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24
Description
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time Frame
Week 8, Week 16, and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Rheumatoid Arthritis (RA) Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA) Active Rheumatoid Arthritis (RA) at time of screening and baseline Exclusion Criteria: Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
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
Consultorios Especializados en Investigaciones Medicas
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1425EKF
Country
Argentina
Facility Name
CER San Juan
City
San Juan
State/Province
Provinica de San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Instituto CAICI
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
OMI
City
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Centro de Investigaciones en Enfermedades Reumaticas
City
Buenos Aires
ZIP/Postal Code
1055
Country
Argentina
Facility Name
Hospital Britanico
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Atencion Integral en Reumatologia
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Investigaciones Reumatológicas y Osteológicas
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1114AAH
Country
Argentina
Facility Name
Centro de Osteopatías Médicas
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Sanatorio Mayo
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital Escuela Gral. San Martin
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro de Investigaciones Reumatologicas
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Dr Miranda Private Practice
City
Santiago
State/Province
Region Metropolitana
Country
Chile
Facility Name
Hospital del Salvador
City
Santiago
State/Province
Region Metropolitana
Country
Chile
Facility Name
Reumalab
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro de Reumatologia y Ortopedia
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Centro Integral de Reumatologia e Inmunologia LTDA
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Facility Name
Foqus Ips Ltda
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Fundacion Instituto de Reumatologia Fernando Chalem
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Preventive Care Ltda
City
Chia
State/Province
Cundinamarca
Country
Colombia
Facility Name
Centro Medico Carlos Ardila Lulle
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Servimed EU
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Hospital Angeles Chapalita
City
Guadajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Centro de Especialidades Medicas del Sureste SA de CV
City
Merida
State/Province
Yucatan
Country
Mexico
Facility Name
Centro de Investigación y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital Christus Mugerza
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Hospital Christus Muguerza del Parque
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Centro de Infusion Marbella
City
Panama
Country
Panama
Facility Name
Centro de Investigacion Marbella
City
Panama
Country
Panama

12. IPD Sharing Statement

Citations:
PubMed Identifier
34496979
Citation
de la Vega M, Guerra Bautista G, Xavier RM, Pacheco-Tena C, Solano G, Pedersen RD, Szumski AE, Borlenghi C, Santana K, Vlahos B. Predictors of response to etanercept-methotrexate treatment: a post hoc logistic regression analysis of a randomized, open-label study in Latin American patients with rheumatoid arthritis. Adv Rheumatol. 2021 Sep 8;61(1):56. doi: 10.1186/s42358-021-00213-4.
Results Reference
derived
PubMed Identifier
31849542
Citation
Guerra Bautista G, Xavier RM, de la Vega M, Simon-Campos JA, Solano G, Pedersen RD, Vlahos B, Borlenghi C. Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis. Open Access Rheumatol. 2019 Dec 12;11:275-281. doi: 10.2147/OARRR.S228866. eCollection 2019.
Results Reference
derived
PubMed Identifier
27006728
Citation
Machado DA, Guzman R, Xavier RM, Simon JA, Mele L, Shen Q, Pedersen R, Kotak S, Vlahos B. Two-Year Safety and Efficacy Experience in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis Treated with Etanercept and Conventional Disease-Modifying Anti-rheumatic Drugs in the Latin American Region. Open Rheumatol J. 2016 Feb 29;10:13-25. doi: 10.2174/1874312901610010013. eCollection 2016.
Results Reference
derived
PubMed Identifier
24907147
Citation
Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.
Results Reference
derived
PubMed Identifier
24356474
Citation
Machado DA, Guzman RM, Xavier RM, Simon JA, Mele L, Pedersen R, Ferdousi T, Koenig AS, Kotak S, Vlahos B. Open-label observation of addition of etanercept versus a conventional disease-modifying antirheumatic drug in subjects with active rheumatoid arthritis despite methotrexate therapy in the Latin American region. J Clin Rheumatol. 2014 Jan;20(1):25-33. doi: 10.1097/RHU.0000000000000055.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-4532&StudyName=Open-Label%20Study%20Comparing%20Etanercept%20to%20Conventional%20Disease%20Modifying%20Antirheumatic%20Drug%20%28DMARD%29%20Therapy
Description
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Learn more about this trial

Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

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