Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
- Conditions
- Arthritis, Juvenile Rheumatoid
- Registration Number
- NCT00034853
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (37)
107.235.8 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
107.235.10 Texas Scottish Rite Hospital
🇺🇸Dallas, Texas, United States
107.235.7 Boehringer Ingelheim Investigational Site
🇺🇸Kansas City, Kansas, United States
107.235.33 Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
107.235.30 Children's Hospital
🇺🇸Seattle, Washington, 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
107.235.32 Arthritis and Osteoporosis Center
🇺🇸Duncansville, Pennsylvania, United States
107.235.24 The Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
107.235.20 Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
🇺🇦Kiev, Ukraine
107.235.60
🇧🇷Sao Paulo, Brazil
107.235.61
🇧🇷Cerqueira César, Brazil
107.235.1 University of Utah School of Medicine
🇺🇸Salt Lake CIty, Utah, United States
107.235.39 Division of Ambulatory Pediatrics
🇺🇸Providence, Rhode Island, United States
107.235.62
🇧🇷Santa Cecília, Brazil
107.235.17 Valley Children's Hospital
🇺🇸Madera, California, United States
107.235.26 Deparment of Rheumatology
🇺🇸Boston, Massachusetts, United States
107.235.37
🇺🇸San Diego, California, United States
107.235.4 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
107.235.36 Arthritis Associates Clinical Research of South Florida
🇺🇸Del Ray Beach, Florida, United States
107.235.12 Boehringer Ingelheim Investigational Site
🇺🇸Hartford, Connecticut, United States
107.235.38 Clinical Research Dept #7006
🇺🇸St. Petersberg, Florida, United States
107.235.21 Miami Children's Hospital
🇺🇸Miami, Florida, United States
107.235.16 Children's Hospital - Department of Rheumatology
🇺🇸New Orleans, Louisiana, United States
107.235.25 University of Louisville
🇺🇸Louisville, Kentucky, 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
107.235.31 Department of Pediatrics
🇺🇸Omaha, Nebraska, United States
107.235.9 Boehringer Ingelheim Investigational Site
🇺🇸St. Louis, Missouri, United States
107.235.23 Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
107.235.40
🇲🇽México, D.F., Mexico
107.235.35 Arthritis and Rheumatic Disease Center
🇺🇸Livingston, New Jersey, United States
107.235.13 Alfred I. DuPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
107.235.71 Institute of Children and Adolescents Health
🇺🇦Kharkov, Ukraine
107.235.70 Children Clinical Hospital No. 1
🇺🇦Kiev, Ukraine
107.235.72 Institute of Pediatrics
🇺🇦Kiev, Ukraine