Status:
COMPLETED
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Juvenile Idiopathic
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00962741
Start Date
September 1 2009
End Date
January 1 2013
Last Update
June 10 2014
Active Locations (42)
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1
Pfizer Investigational Site
Westmead, Sydney, New South Wales, Australia, 2145
2
Pfizer Investigational Site
Parkville, Melbourne, Victoria, Australia, 3052
3
Pfizer Investigational Site
Ghent, Belgium, Belgium, 9000
4
Pfizer Investigational Site
Brussels, Belgium, 1200