Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Arthritis, Juvenile Rheumatoid

Treatments: Drug: naproxen oral suspension; Drug: meloxicam oral suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034853

107.235

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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