Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Meloxicam; Naproxen

Criteria

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