Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

NCT00034853 | Completed Phase 3

• 1 other identifier: 107.235
• Study Type: interventional
• Target: 180
• Locations: 4 countries
• Sites: 37

Brief Summary

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

Conditions

Arthritis, Juvenile Rheumatoid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

meloxicam oral suspension DRUG

naproxen oral suspension DRUG

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (37)

107.235.23 Arkansas Children's Hospital

Little Rock, Arkansas, United States

Location

107.235.17 Valley Children's Hospital

Madera, California, United States

Location

107.235.37

San Diego, California, United States

Location

107.235.4 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

107.235.12 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

107.235.13 Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

Location

107.235.36 Arthritis Associates Clinical Research of South Florida

Delray Beach, Florida, United States

Location

107.235.21 Miami Children's Hospital

Miami, Florida, United States

Location

107.235.38 Clinical Research Dept #7006

Saint Petersberg, Florida, United States

Location

107.235.8 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

107.235.7 Boehringer Ingelheim Investigational Site

Kansas City, Kansas, United States

Location

107.235.25 University of Louisville

Louisville, Kentucky, United States

Location

107.235.16 Children's Hospital - Department of Rheumatology

New Orleans, Louisiana, United States

Location

107.235.26 Deparment of Rheumatology

Boston, Massachusetts, United States

Location

107.235.2 E15 Mayo Clinic

Rochester, Minnesota, United States

Location

107.235.18 Washington University School of Medicine

St Louis, Missouri, United States

Location

107.235.9 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

107.235.31 Department of Pediatrics

Omaha, Nebraska, United States

Location

107.235.35 Arthritis and Rheumatic Disease Center

Livingston, New Jersey, United States

Location

107.235.24 The Children's Hospital of Buffalo

Buffalo, New York, United States

Location

107.235.19 Columbia Presbyterian Medical Center

New York, New York, United States

Location

107.235.22 Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Location

107.235.33 Healthcare Research Consultants

Tulsa, Oklahoma, United States

Location

107.235.32 Arthritis and Osteoporosis Center

Duncansville, Pennsylvania, United States

Location

107.235.39 Division of Ambulatory Pediatrics

Providence, Rhode Island, United States

Location

107.235.10 Texas Scottish Rite Hospital

Dallas, Texas, United States

Location

107.235.1 University of Utah School of Medicine

Salt Lake City, Utah, United States

Location

107.235.30 Children's Hospital

Seattle, Washington, United States

Location

107.235.20 Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

107.235.61

Cerqueira César, Brazil

Location

107.235.62

Santa Cecília, Brazil

Location

107.235.60

São Paulo, Brazil

Location

107.235.40

México, D.F., Mexico

Location

107.235.71 Institute of Children and Adolescents Health

Kharkiv, Ukraine

Location

107.235.70 Children Clinical Hospital No. 1

Kiev, Ukraine

Location

107.235.72 Institute of Pediatrics

Kiev, Ukraine

Location

107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"

Kiev, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: December 1, 2000
• Primary Completion: June 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (29); BR (3); ME (1); UA (4)