Status:
COMPLETED
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Enthesitis Related Arthritis (ERA)
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthriti...
Eligibility Criteria
Inclusion
- Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR);
- Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
- Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
Exclusion
- Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA;
- Psoriasis or a history of psoriasis in the patient or first-degree relative;
- Presence of Immunoglobulin M (IgM) rheumatoid factor;
- Presence of systemic JIA;
- History of inflammatory bowel disease;
- previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA;
- Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01166282
Start Date
September 1 2010
End Date
December 1 2015
Last Update
July 12 2021
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