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Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PEAPOD)

Primary Purpose

Active Juvenile Psoriatic Arthritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Juvenile Psoriatic Arthritis focused on measuring Apremilast, Otezla®, Juvenile psoriatic arthritis, Inflammatory disorders

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female participants 5 to < 18 years of age at the time of randomization.

  • Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:

    • Arthritis and psoriasis, OR
    • Arthritis with at least 2 of the following:
    • Dactylitis
    • Nail pitting or onycholysis
    • Psoriasis in a first-degree relative
  • Active disease: at least 3 active joints (including distal interphalangeal joints).
  • Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

  • Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

    • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
    • Ankylosing spondylitis, enthesitis-related arthritis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
    • History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
    • Presence of systemic juvenile idiopathic arthritis (JIA).
  • Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
  • Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Sites / Locations

  • Landeskrankenhaus BregenzRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • Centre Hospitalier Regional de la CitadelleRecruiting
  • Ziekenhuis Netwerk Antwerpen Jan PalfijnRecruiting
  • Hospices Civils de Lyon Hopital Femme Mere EnfantRecruiting
  • Hopital Jeanne de FlandreRecruiting
  • Charite - Universitaetsmedizin Berlin, Campus VirchowRecruiting
  • Universitaetsklinik Carl Gustav CarusRecruiting
  • An der Schoen Klinik Hamburg EilbekRecruiting
  • Asklepios Kinderklinik Sankt Augustin GmbHRecruiting
  • Agia Sofia Children HospitalRecruiting
  • Attikon University General HospitalRecruiting
  • General Hospital of Thessaloniki IppokrateioRecruiting
  • Ospedale Santissima AnnunziataRecruiting
  • IRCCS Istituto Giannina GasliniRecruiting
  • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano PiniRecruiting
  • IRCCS Ospedale Pediatrico Bambino GesuRecruiting
  • Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonineRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w KrakowieRecruiting
  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w LodziRecruiting
  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory ReicherRecruiting
  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas MonizRecruiting
  • Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa MariaRecruiting
  • Centro Hospitalar Universtario de Sao Joao, EPERecruiting
  • Spitalul Clinic de Urgenta pentru Copii ClujRecruiting
  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu TimisoaraRecruiting
  • Panorama Medical CentreRecruiting
  • Groote Schuur HospitalRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Universitari Vall d HebronRecruiting
  • Hospital Sant Joan de DeuRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Universitario La PazRecruiting
  • Hacettepe Universitesi Tip FakultesiRecruiting
  • Istanbul Universitesi Istanbul Tip FakultesiRecruiting
  • Istanbul Universitesi Cerrahpasa Tip FakultesiRecruiting
  • Umraniye Egitim ve Arastirma HastanesiRecruiting
  • Birmingham Childrens HospitalRecruiting
  • Alder Hey Childrens HospitalRecruiting
  • Nottingham Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast

Placebo to Apremilast

Arm Description

Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.

Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.

Outcomes

Primary Outcome Measures

Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 percent. The ACR Pedi consists of 6 core criteria: physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]); number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) number of joints with limited range of motion laboratory marker of inflammation (C-reactive protein [CRP]).

Secondary Outcome Measures

Change from Baseline in Participants Assessment of Pain at Week 16
The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain".
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20 percent, >50 percent, >70 percent or >90 percent respectively. The ACR Pedi consists of 6 core criteria: PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being functional ability (assessed using the CHAQ) number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (CRP).
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity.
Change from Baseline in the Assessment of Overall Well-being at Week 16
Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver.
Change from Baseline in the Number of Joints with Active Arthritis at Week 16
Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both.
Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16
Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life. The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ.
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]). There are 4 components of the JADAS: Active joint count (71 joints) PGA (0 to 100) measured on a VAS Patient/parent global assessment of well-being (0 to 100) measured on a VAS CRP (normalized to a 0 to 10 scale) The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles . The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome.
Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
PsA flares are defined as more than or equal to 30 percent worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30 percent improvement in not more than 1 of 6 ACR Pedi core set variables.
Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The PASI score is determined only for subjects whose BSA involved by psoriasis is ≥3 percent. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on the 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90 percent < 100 percent involvement). The sum of scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percentage of BSA. The resultant values for each anatomic region are then summed to yield the PASI score.
Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Change from Baseline in Tanner Staging at Week 52
Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.
Change from Baseline in Body Weight at Week 56
Change from Baseline in Height at Week 56
Change from Baseline in Body Mass Index (BMI) at Week 56
Plasma Concentrations of Apremilast
Taste and Acceptability of Apremilast
Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.

Full Information

First Posted
March 16, 2021
Last Updated
October 18, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04804553
Brief Title
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Acronym
PEAPOD
Official Title
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
March 21, 2028 (Anticipated)
Study Completion Date
December 29, 2028 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Juvenile Psoriatic Arthritis
Keywords
Apremilast, Otezla®, Juvenile psoriatic arthritis, Inflammatory disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomized to receive apremilast or placebo in the double-blind 16 week treatment phase. Then, the participants will all receive apremilast for a further 36 weeks in the active treatment phase. The participants not continuing to receive apremilast through the Post-Trial Access Program or Open-label Extension study will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apremilast
Arm Type
Experimental
Arm Description
Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
Arm Title
Placebo to Apremilast
Arm Type
Placebo Comparator
Arm Description
Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla®
Intervention Description
Participants will receive apremilast orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive the matching placebo orally.
Primary Outcome Measure Information:
Title
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
Description
The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 percent. The ACR Pedi consists of 6 core criteria: physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]); number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) number of joints with limited range of motion laboratory marker of inflammation (C-reactive protein [CRP]).
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change from Baseline in Participants Assessment of Pain at Week 16
Description
The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain".
Time Frame
Baseline to Week 16
Title
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
Description
The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20 percent, >50 percent, >70 percent or >90 percent respectively. The ACR Pedi consists of 6 core criteria: PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being functional ability (assessed using the CHAQ) number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion 6. laboratory marker of inflammation (CRP).
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
Description
PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity.
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Assessment of Overall Well-being at Week 16
Description
Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver.
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Number of Joints with Active Arthritis at Week 16
Description
Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both.
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16
Time Frame
Baseline to Week 16
Title
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
Description
The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life. The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ.
Time Frame
Baseline to Week 16
Title
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
Description
JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]). There are 4 components of the JADAS: Active joint count (71 joints) PGA (0 to 100) measured on a VAS Patient/parent global assessment of well-being (0 to 100) measured on a VAS CRP (normalized to a 0 to 10 scale) The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles . The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome.
Time Frame
Baseline to Week 16
Title
Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
Description
PsA flares are defined as more than or equal to 30 percent worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30 percent improvement in not more than 1 of 6 ACR Pedi core set variables.
Time Frame
Baseline to Week 16
Title
Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
Description
PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The PASI score is determined only for subjects whose BSA involved by psoriasis is ≥3 percent. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on the 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90 percent < 100 percent involvement). The sum of scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percentage of BSA. The resultant values for each anatomic region are then summed to yield the PASI score.
Time Frame
Baseline to Week 16
Title
Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to Week 56
Title
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Time Frame
Up to Week 56
Title
Change from Baseline in Tanner Staging at Week 52
Description
Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.
Time Frame
Baseline to Week 52
Title
Change from Baseline in Body Weight at Week 56
Time Frame
Baseline to Week 56
Title
Change from Baseline in Height at Week 56
Time Frame
Baseline to Week 56
Title
Change from Baseline in Body Mass Index (BMI) at Week 56
Time Frame
Baseline to Week 56
Title
Plasma Concentrations of Apremilast
Time Frame
Week 2: 0-5 hours post dose; Week 8: 2 hours post dose; Week 16: 4 hours post-dose; Week 28: pre dose; Week 40: pre dose; Week 52: pre dose
Title
Taste and Acceptability of Apremilast
Description
Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.
Time Frame
Baseline and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female participants 5 to < 18 years of age at the time of randomization. Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration: Arthritis and psoriasis, OR Arthritis with at least 2 of the following: Dactylitis Nail pitting or onycholysis Psoriasis in a first-degree relative Active disease: at least 3 active joints (including distal interphalangeal joints). Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents). Exclusion Criteria: Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include: Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart Presence of systemic juvenile idiopathic arthritis (JIA). Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Landeskrankenhaus Bregenz
City
Bregenz
ZIP/Postal Code
6900
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ziekenhuis Netwerk Antwerpen Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon Hopital Femme Mere Enfant
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Jeanne de Flandre
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinik Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
An der Schoen Klinik Hamburg Eilbek
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Kinderklinik Sankt Augustin GmbH
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Individual Site Status
Recruiting
Facility Name
Agia Sofia Children Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital of Thessaloniki Ippokrateio
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Name
Ospedale Santissima Annunziata
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Giannina Gaslini
City
Genova
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 EA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universtario de Sao Joao, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic de Urgenta pentru Copii Cluj
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
City
Timisoara
ZIP/Postal Code
300011
Country
Romania
Individual Site Status
Recruiting
Facility Name
Panorama Medical Centre
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Canarias
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Deu
City
Esplugues De Llorbregat
State/Province
Cataluña
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Umraniye Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34764
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Birmingham Childrens Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Alder Hey Childrens Hospital
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham Childrens Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

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