Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Study Overview
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Brief Summary
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To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)

Official Title
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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

Conditions
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Arthritis, Juvenile Rheumatoid

Intervention / Treatment
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* Drug: meloxicam oral suspension
* Drug: naproxen oral suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 require nonsteroidal anti-inflammatory drugs (NSAIDs) children aged 2-17 years Exclusion Criteria: systemic course of juvenile idiopathic arthritis all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to JIA) that could interfere with conduct of clinical trial weight of 9 kg or less pregnancy or breast feeding females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study history of bleeding disorder, gastrointestinal bleeding, or cerebrovascular bleeding peptic ulcer past 6 months more than 1 disease modifying anti-rheumatic drug (DMARD) or change in DMARD during 3 months prior change corticosteroids during 1 month prior systemic corticosteroids greater than 10 mg/d, hydroxychloroquine greater than 10/mg/d, cyclosporine greater than 5 mg/kg/d., methotrexate greater than 15 mg/m2/wk, cytotoxic agents, gold, D-penicilamine, sulfasalazine, glucosamine, and investigational products etanercept during 1 month prior; infliximab during 2 months prior; intra-articular corticosteroids during 1 month prior patients requiring concomitant other NSAID including topical (excluding ophthalmic) requirement for use of other NSAIDs, anticoagulants, phenothiazine, lithium, or ACTH insufficient effect or intolerability to naproxen or meloxicam known or suspected hypersensitivity to trial meds or their excipients requirement of chronic H2 antagonist history of asthma, nasal polyps, angioneurotic edema, or urticaria with aspirin or NSAIDs planned surgical procedures during study investigational drug exposure during this trial or within 30 days (or 6 half lives, whichever greater) prior previous participation in this trial patients with known drug or alcohol abuse patient, parent or legal representative unable to understand and to comply with protocol

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: meloxicam oral suspension|nan|
|Drug: naproxen oral suspension|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | weeks 4, 8, 12, 18, and 24 |