Arthritis, Juvenile Rheumatoid
Conditions
Brief summary
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)
Interventions
DRUGmeloxicam oral suspension
DRUGnaproxen oral suspension
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Brazil, Mexico, Ukraine, United States
Outcome results
None listed