Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
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A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis
Study Start Date :
Actual Primary Completion Date :
Resource links provided by the National Library of Medicine
Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate; [ Time Frame: week 12 ]
Secondary Outcome Measures :
Individual core set outcome criteria; final global assessment of efficacy; tolerability; AE incidence and intensity; withdrawals; acetaminophen consumption; safety labs: physical examination; hospitalization for gastrointestinal (GI) SAE, GI AE [ Time Frame: weeks 4, 8, 12, 18, and 24 ]
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
diagnosis of juvenile idiopathic arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease;
active arthritis of at least 2 joints
at least 2 other abnormal variables of the 5 remaining core set parameters