Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
Arthritis, Juvenile Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid
Eligibility 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
Sites / Locations
- 107.235.23 Arkansas Children's Hospital
- 107.235.17 Valley Children's Hospital
- 107.235.37
- 107.235.4 Boehringer Ingelheim Investigational Site
- 107.235.12 Boehringer Ingelheim Investigational Site
- 107.235.13 Alfred I. DuPont Hospital for Children
- 107.235.36 Arthritis Associates Clinical Research of South Florida
- 107.235.21 Miami Children's Hospital
- 107.235.38 Clinical Research Dept #7006
- 107.235.8 Boehringer Ingelheim Investigational Site
- 107.235.7 Boehringer Ingelheim Investigational Site
- 107.235.25 University of Louisville
- 107.235.16 Children's Hospital - Department of Rheumatology
- 107.235.26 Deparment of Rheumatology
- 107.235.2 E15 Mayo Clinic
- 107.235.18 Washington University School of Medicine
- 107.235.9 Boehringer Ingelheim Investigational Site
- 107.235.31 Department of Pediatrics
- 107.235.35 Arthritis and Rheumatic Disease Center
- 107.235.24 The Children's Hospital of Buffalo
- 107.235.19 Columbia Presbyterian Medical Center
- 107.235.22 Oklahoma Medical Research Foundation
- 107.235.33 Healthcare Research Consultants
- 107.235.32 Arthritis and Osteoporosis Center
- 107.235.39 Division of Ambulatory Pediatrics
- 107.235.10 Texas Scottish Rite Hospital
- 107.235.1 University of Utah School of Medicine
- 107.235.30 Children's Hospital
- 107.235.20 Medical College of Wisconsin
- 107.235.61
- 107.235.62
- 107.235.60
- 107.235.40
- 107.235.71 Institute of Children and Adolescents Health
- 107.235.70 Children Clinical Hospital No. 1
- 107.235.72 Institute of Pediatrics
- 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"