Clinical trial NCT00034853: Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
Official title: A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Juvenile Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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;
timeFrame: week 12
Secondary outcomes:
measure: 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
timeFrame: weeks 4, 8, 12, 18, and 24
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: 107.235.23 Arkansas Children's Hospital
state: Arkansas
city: Madera
country: United States
facility: 107.235.17 Valley Children's Hospital
state: California
city: San Diego
country: United States
facility: 107.235.37
state: California
city: Denver
country: United States
facility: 107.235.4 Boehringer Ingelheim Investigational Site
state: Colorado
city: Hartford
country: United States
facility: 107.235.12 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Wilmington
country: United States
facility: 107.235.13 Alfred I. DuPont Hospital for Children
state: Delaware
city: Del Ray Beach
country: United States
facility: 107.235.36 Arthritis Associates Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: 107.235.21 Miami Children's Hospital
state: Florida
city: St. Petersberg
country: United States
facility: 107.235.38 Clinical Research Dept #7006
state: Florida
city: Chicago
country: United States
facility: 107.235.8 Boehringer Ingelheim Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: 107.235.7 Boehringer Ingelheim Investigational Site
state: Kansas
city: Louisville
country: United States
facility: 107.235.25 University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: 107.235.16 Children's Hospital - Department of Rheumatology
state: Louisiana
city: Boston
country: United States
facility: 107.235.26 Deparment of Rheumatology
state: Massachusetts
city: Rochester
country: United States
facility: 107.235.2 E15 Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: 107.235.18 Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: 107.235.9 Boehringer Ingelheim Investigational Site
state: Missouri
city: Omaha
country: United States
facility: 107.235.31 Department of Pediatrics
state: Nebraska
city: Livingston
country: United States
facility: 107.235.35 Arthritis and Rheumatic Disease Center
state: New Jersey
city: Buffalo
country: United States
facility: 107.235.24 The Children's Hospital of Buffalo
state: New York
city: New York
country: United States
facility: 107.235.19 Columbia Presbyterian Medical Center
state: New York
city: Oklahoma City
country: United States
facility: 107.235.22 Oklahoma Medical Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: 107.235.33 Healthcare Research Consultants
state: Oklahoma
city: Duncansville
country: United States
facility: 107.235.32 Arthritis and Osteoporosis Center
state: Pennsylvania
city: Providence
country: United States
facility: 107.235.39 Division of Ambulatory Pediatrics
state: Rhode Island
city: Dallas
country: United States
facility: 107.235.10 Texas Scottish Rite Hospital
state: Texas
city: Salt Lake CIty
country: United States
facility: 107.235.1 University of Utah School of Medicine
state: Utah
city: Seattle
country: United States
facility: 107.235.30 Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: 107.235.20 Medical College of Wisconsin
state: Wisconsin
city: Cerqueira César
country: Brazil
facility: 107.235.61
city: Santa Cecília
country: Brazil
facility: 107.235.62
city: Sao Paulo
country: Brazil
facility: 107.235.60
city: México, D.F.
country: Mexico
facility: 107.235.40
city: Kharkov
country: Ukraine
facility: 107.235.71 Institute of Children and Adolescents Health
city: Kiev
country: Ukraine
facility: 107.235.70 Children Clinical Hospital No. 1
city: Kiev
country: Ukraine
facility: 107.235.72 Institute of Pediatrics
city: Kiev
country: Ukraine
facility: 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: