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Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
meloxicam oral suspension
naproxen oral suspension
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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"

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2002
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00034853
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
meloxicam oral suspension
Intervention Type
Drug
Intervention Name(s)
naproxen oral suspension
Primary Outcome Measure Information:
Title
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;
Time Frame
week 12
Secondary Outcome Measure Information:
Title
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
Time Frame
weeks 4, 8, 12, 18, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
107.235.23 Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
107.235.17 Valley Children's Hospital
City
Madera
State/Province
California
Country
United States
Facility Name
107.235.37
City
San Diego
State/Province
California
Country
United States
Facility Name
107.235.4 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
107.235.12 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
107.235.13 Alfred I. DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
Country
United States
Facility Name
107.235.36 Arthritis Associates Clinical Research of South Florida
City
Del Ray Beach
State/Province
Florida
Country
United States
Facility Name
107.235.21 Miami Children's Hospital
City
Miami
State/Province
Florida
Country
United States
Facility Name
107.235.38 Clinical Research Dept #7006
City
St. Petersberg
State/Province
Florida
Country
United States
Facility Name
107.235.8 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
107.235.7 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
107.235.25 University of Louisville
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
107.235.16 Children's Hospital - Department of Rheumatology
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
107.235.26 Deparment of Rheumatology
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
107.235.2 E15 Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
107.235.18 Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
107.235.9 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
107.235.31 Department of Pediatrics
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
107.235.35 Arthritis and Rheumatic Disease Center
City
Livingston
State/Province
New Jersey
Country
United States
Facility Name
107.235.24 The Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
Country
United States
Facility Name
107.235.19 Columbia Presbyterian Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
107.235.22 Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
107.235.33 Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
107.235.32 Arthritis and Osteoporosis Center
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
107.235.39 Division of Ambulatory Pediatrics
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
107.235.10 Texas Scottish Rite Hospital
City
Dallas
State/Province
Texas
Country
United States
Facility Name
107.235.1 University of Utah School of Medicine
City
Salt Lake CIty
State/Province
Utah
Country
United States
Facility Name
107.235.30 Children's Hospital
City
Seattle
State/Province
Washington
Country
United States
Facility Name
107.235.20 Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
107.235.61
City
Cerqueira César
Country
Brazil
Facility Name
107.235.62
City
Santa Cecília
Country
Brazil
Facility Name
107.235.60
City
Sao Paulo
Country
Brazil
Facility Name
107.235.40
City
México, D.F.
Country
Mexico
Facility Name
107.235.71 Institute of Children and Adolescents Health
City
Kharkov
Country
Ukraine
Facility Name
107.235.70 Children Clinical Hospital No. 1
City
Kiev
Country
Ukraine
Facility Name
107.235.72 Institute of Pediatrics
City
Kiev
Country
Ukraine
Facility Name
107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.235.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.235_literature.pdf
Description
Related Info

Learn more about this trial

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

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