Status:
COMPLETED
Determining Predictors of Safe Discontinuation of Anti-TNF Treatment in JIA
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
4-20 years
Phase:
PHASE4
Brief Summary
Polyarticular juvenile idiopathic arthritis (Poly JIA) is a form of juvenile arthritis, which is a chronic disease affecting approximately 250,000 people younger than 16 years of age. Poly JIA can be ...
Detailed Description
Juvenile arthritis is a chronic disease affecting approximately 250,000 people younger than 16 years of age in the United States. Its symptoms include swelling, pain, and damage in the joints. Juvenil...
Eligibility Criteria
Inclusion
- Diagnosis of polyarticular JIA (rheumatoid factor + and rheumatoid factor -) or extended oligo JIA by the International League of Associations for Rheumatology (ILAR) criteria
- Receiving therapy with one of the currently available anti-TNF biologics: infliximab, etanercept, or adalimumab
- Absence of any of the FDA label exclusions for anti-TNF therapy
- Receiving slit lamp exams performed at regular intervals in accordance with the published American Academy of Pediatrics guidelines
- Baseline hemoglobin \>10 g/dl
- Absence of joints with active arthritis, using the American College of Rheumatology (ACR) definition of "active joint"
- Absence of fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA
- Absence of active uveitis, as per an exam by an ophthalmologist
- Normal erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP); if above normal range, must be not attributable to JIA
- Physician's global assessment of disease activity indicating absence of disease activity, defined as the best score obtainable on the scale used
- Duration of morning stiffness less than or equal to 15 minutes
Exclusion
- Diagnosis of a type of JIA other than polyarticular JIA
- Diagnosis of another inflammatory disease that may affect laboratory results or ability to discontinue anti-TNF biologic therapy
- Concurrent treatment with any biologic agent other than infliximab, etanercept, or adalimumab
- previous treatment with rituximab
- concurrent treatment for JIA with corticosteroids \>0.2 mg/kg/day OR \>10 mg/day
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00792233
Start Date
June 1 2009
End Date
October 1 2015
Last Update
April 15 2016
Active Locations (16)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106