Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
Completed · Phase 3
Conditions studied: Arthritis, Juvenile Rheumatoid
In brief
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)
Key facts
- Study ID
- NCT00034853
- Run by
- Boehringer Ingelheim
- People needed
- 180
- Starts
- 2000-12-01
- Last updated by the study team
- 2013-11-01
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 107.235.23 Arkansas Children's Hospital — Little Rock, Arkansas, United States
- 107.235.17 Valley Children's Hospital — Madera, California, United States
- 107.235.37 — San Diego, California, United States
- 107.235.4 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
- 107.235.12 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
- 107.235.13 Alfred I. DuPont Hospital for Children — Wilmington, Delaware, United States
- 107.235.36 Arthritis Associates Clinical Research of South Florida — Delray Beach, Florida, United States
- 107.235.21 Miami Children's Hospital — Miami, Florida, United States
- 107.235.38 Clinical Research Dept #7006 — Saint Petersberg, Florida, United States
- 107.235.8 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
- 107.235.7 Boehringer Ingelheim Investigational Site — Kansas City, Kansas, United States
- 107.235.25 University of Louisville — Louisville, Kentucky, United States
- 107.235.16 Children's Hospital - Department of Rheumatology — New Orleans, Louisiana, United States
- 107.235.26 Deparment of Rheumatology — Boston, Massachusetts, United States
- 107.235.2 E15 Mayo Clinic — Rochester, Minnesota, United States
- 107.235.18 Washington University School of Medicine — St Louis, Missouri, United States
- 107.235.9 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
- 107.235.31 Department of Pediatrics — Omaha, Nebraska, United States
- 107.235.35 Arthritis and Rheumatic Disease Center — Livingston, New Jersey, United States
- 107.235.24 The Children's Hospital of Buffalo — Buffalo, New York, United States
- 107.235.19 Columbia Presbyterian Medical Center — New York, New York, United States
- 107.235.22 Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
- 107.235.33 Healthcare Research Consultants — Tulsa, Oklahoma, United States
- 107.235.32 Arthritis and Osteoporosis Center — Duncansville, Pennsylvania, United States
- 107.235.39 Division of Ambulatory Pediatrics — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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