Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

NCT00962741

Last updated date
Study Location
Pfizer Investigational Site
Westmead, Sydney, New South Wales, 2145, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopathic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Juvenile Idiopathic
Intervention  ICMJE Drug: Etanercept
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Other Name: Enbrel
Study Arms  ICMJE Experimental: 1
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Intervention: Drug: Etanercept
Publications * Foeldvari I, Constantin T, Vojinovi? J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Su?i? G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dole?alová 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2012)
127
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2009)
100
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Colombia,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Spain
Removed Location Countries Argentina,   Brazil,   Denmark,   Greece,   Sweden,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00962741
Other Study ID Numbers  ICMJE 0881A1-3338
B1801014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP