Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Arthritis, Juvenile Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034853
• Other study ID #: 107.235
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2002
• Last updated: October 31, 2013
• Start date: December 2000

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of HealthBrazil: Ministry of HealthMexico: Ministry of HealthUkraine: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00274482

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid
• Arthritis, Rheumatoid

Intervention

Drug:
• meloxicam oral suspension

• naproxen oral suspension

Locations

Country	Name	City	State
Brazil	107.235.61	Cerqueira César
Brazil	107.235.62	Santa Cecília
Brazil	107.235.60	Sao Paulo
Mexico	107.235.40	México, D.F.
Ukraine	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	107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"	Kiev
United States	107.235.26 Deparment of Rheumatology	Boston	Massachusetts
United States	107.235.24 The Children's Hospital of Buffalo	Buffalo	New York
United States	107.235.8 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	107.235.10 Texas Scottish Rite Hospital	Dallas	Texas
United States	107.235.36 Arthritis Associates Clinical Research of South Florida	Del Ray Beach	Florida
United States	107.235.4 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	107.235.32 Arthritis and Osteoporosis Center	Duncansville	Pennsylvania
United States	107.235.12 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	107.235.7 Boehringer Ingelheim Investigational Site	Kansas City	Kansas
United States	107.235.23 Arkansas Children's Hospital	Little Rock	Arkansas
United States	107.235.35 Arthritis and Rheumatic Disease Center	Livingston	New Jersey
United States	107.235.25 University of Louisville	Louisville	Kentucky
United States	107.235.17 Valley Children's Hospital	Madera	California
United States	107.235.21 Miami Children's Hospital	Miami	Florida
United States	107.235.20 Medical College of Wisconsin	Milwaukee	Wisconsin
United States	107.235.16 Children's Hospital - Department of Rheumatology	New Orleans	Louisiana
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	107.235.31 Department of Pediatrics	Omaha	Nebraska
United States	107.235.39 Division of Ambulatory Pediatrics	Providence	Rhode Island
United States	107.235.2 E15 Mayo Clinic	Rochester	Minnesota
United States	107.235.1 University of Utah School of Medicine	Salt Lake CIty	Utah
United States	107.235.37	San Diego	California
United States	107.235.30 Children's Hospital	Seattle	Washington
United States	107.235.18 Washington University School of Medicine	St. Louis	Missouri
United States	107.235.9 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	107.235.38 Clinical Research Dept #7006	St. Petersberg	Florida
United States	107.235.33 Healthcare Research Consultants	Tulsa	Oklahoma
United States	107.235.13 Alfred I. DuPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Brazil,  Mexico,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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