Meloxicam Suspension in Juvenile Rheumatoid Arthritis (JRA)

Condition(s) targeted: Juvenile Rheumatoid Arthritis

Intervention: Meloxicam (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

The purpose of this 6 month study is to determine how safe and effective meloxicam oral suspension (liquid taken by mouth) is in children with JRA.

Official title: A 12 Wk Double-Blind Randomized Trial, With a 12 Wk Open-Label Extension, to Investigate Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With JRA.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: The primary aim of this trial is to compare the efficacy and safety of several doses of meloxicam oral suspension (0. 125 mg/kg and 0. 25 mg/kg with a 0. 125 mg/kg dose escalation at 4 weeks) administered once daily with naproxen oral suspension (10 mg/kg with a dose escalation to15 mg/kg at 4 weeks administered in divided doses twice daily) over a period of 12 weeks in the treatment of patients with JRA. The 12-week double-blind portion of the trial is followed by an open-label extension of meloxicam oral suspension at 0. 375 mg/kg/day to obtain additional safety information. A subgroup of patients will participate in a pharmacokinetic study at the conclusion of the open label extension phase.

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females 2-17 years old.

- Diagnosis of JRA for at least 6 weeks, onset of disease less than 16 years old.

- Current course of disease pauciarthritic, extended pauciarthritic, or polyarthritic.

- Active arthritis of at least 2 joints.

- Patient requires therapy with an NSAID.

- At screening, patient has at least 2 abnormal variables among the following: CHAQ,

ESR, Investigator’s Assessment of Overall Disease Activity, or Parent’s Assessment of Overall Well-Being.

Exclusion Criteria:

- Systemic course of JRA

- Weight less than 9kg

- History of bleeding disorders, gastrointestinal bleeding, peptic ulcer,

cerebrovascular bleeding, rheumatic conditions other than JRA, or any disease that could interfere with the trial or the child’s safety.

Hospital de Ninos, Buenos Aires 01430, Argentina

Epm Universidade Federal de Sao Paulo, Sao Paulo 04025, Brazil

Hospital General de Mexico, Mexico City 06726, Mexico

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States

Valley Children's Hospital, Rheumatology Dept., Madera, California 93738, United States

Children's Hospital Research Clinic, San Diego, California 92123, United States

Children's Hospital, Denver, Colorado 80218, United States

Miami Children's Hospital, Miami, Florida 33155, United States

Arthritis Association Clinical Research of So. Florida, Delray Beach, Florida 33484, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

University of Louisville, Dept. of Pediatrics, Louisville, Kentucky 40202, United States

Children's Hospital, Dept. of Rheumatology, New Orleans, Louisiana 70118, United States

Children's Hospital Medical Center, Dept. of Rheumatology, Boston, Massachusetts 02115, United States

E15 Mayo Clinic, Rochester, Minnesota 55905, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

Creighton University, Dept. of Pediatrics, Omaha, Nebraska 68178, United States

Arthritis and Rheumatic Disease Center, Livingston, New Jersey 07039, United States

Columbia Presbyterian Medical Center, New York, New York 10032, United States

The Children's Hospital of Buffalo, Div. of Allergy, Immunology and Rheumatology, Buffalo, New York 14222, United States

Oklahoma Medical Research Foundation, Div. of Rheumatology, Oklahoma City, Oklahoma 73104, United States

HealthCare Research Consultants, Tulsa, Oklahoma 74135, United States

Arthritis and Osteoporosis Center, Duncansville, Pennsylvania 16635, United States

Div. of Ambulatory Pediatrics, Hasbro Children's Hospital, Providence, Rhode Island 02903, United States

Texas Scottish Rite Hospital, Dept. of Pediatric Rheumatology, Dallas, Texas 75219, United States

University of Utah School of Medicine, Dept. of Pediatrics, Salt Lake City, Utah 84132, United States

Children's Hospital, Pediatric Rheumatology, Seattle, Washington 98105, United States

Medical College of Wisconsin, Dept. of Pediatrics, Milwaukee, Wisconsin 53226, United States

Starting date: December 2000
Ending date: June 2003
Last updated: March 27, 2006