Clinical trial NCT00962741: Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Official title: A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Juvenile Idiopathic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 127
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.
* \>= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

Exclusion Criteria:

* Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
* Other rheumatic diseases.
* Active uveitis within 6 months of the baseline visit.
* Any other significant health problem.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With an ACR Pedi 30 Response
timeFrame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 50 Response
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 70 Response
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 90 Response
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 100 Response
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Physician's Global Assessment (PGA) of Disease Activity
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Patient/Parent Global Assessment
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Patient/Parent Global Assessment: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Patient/Parent Global Assessment: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Patient/Parent Global Assessment: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Active Joints
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Active Joints: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Active Joints: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Active Joints: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Joints With Limitation of Motion
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Joints With Limitation of Motion: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Joints With Limitation of Motion: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Joints With Limitation of Motion: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: C-reactive Protein (CRP)
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: C-reactive Protein (CRP): eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: C-reactive Protein (CRP): ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: C-reactive Protein (CRP): PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Pain Assessment
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Pain Assessment: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Pain Assessment: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Pain Assessment: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Duration of Morning Stiffness
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Duration of Morning Stiffness: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Duration of Morning Stiffness: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Duration of Morning Stiffness: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Childhood Health Assessment Questionnaire (CHAQ) Score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Other outcomes:
measure: Tender Entheseal Assessment for ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Overall Back Pain Score for ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Nocturnal Back Pain Score for ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Modified Schober's Test for ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Week 12, Week 96
measure: Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
timeFrame: Week 12, Week 96
measure: Number of Participants With Adverse Events (AEs): ERA Sub-population
timeFrame: Week 12, Week 96
measure: Number of Participants With Adverse Events (AEs): PsA Sub-population
timeFrame: Week 12, Week 96
measure: Tanner Assessment Score by Age Group
timeFrame: Baseline, Week 12, Week 48, Week 96
measure: Tanner Assessment Score by Age Group for eoJIA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 96
measure: Tanner Assessment Score by Age Group for ERA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 96
measure: Tanner Assessment Score by Age Group for PsA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 96
measure: Height z-Score by Age Group
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Height z-Score by Age Group for eoJIA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Height z-Score by Age Group for ERA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Height z-Score by Age Group for PsA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Weight z-Scores by Age Group
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Weight z-Scores by Age Group for eoJIA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Weight z-Scores by Age Group for ERA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Weight z-Scores by Age Group for PsA Sub-population
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
measure: Body Mass Index (BMI) z-Score by Age Group
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population
timeFrame: Baseline, Week 12, Week 48, Week 72, Week 96
measure: Number of Participants With Anti-etanercept Antibodies
timeFrame: Baseline up to Week 12, Week 48, Week 96
measure: Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population
timeFrame: Baseline up to Week 12, Week 48, Week 96
measure: Number of Participants With Anti-etanercept Antibodies: ERA Sub-population
timeFrame: Baseline up to Week 12, Week 48, Week 96
measure: Number of Participants With Anti-etanercept Antibodies: PsA Sub-population
timeFrame: Baseline up to Week 12, Week 48, Week 96
measure: Number of Participants With Neutralizing Anti-etanercept Antibodies
timeFrame: Baseline up to Week 12, Week 48, Week 96
Locations:
city: Westmead, Sydney
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Parkville, Melbourne
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Le Kremlin Bicetre
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: St. Augustin
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Chieti
country: Italy
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Nis
country: Serbia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Esplugues de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.