A Study of Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Condition(s) targeted: Arthritis, Juvenile Rheumatoid

Intervention: meloxicam oral suspension (Drug); naproxen oral suspension (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

Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis

Official title: Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)

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

Primary outcome: ACR Pediatric 30 (composite endpoint) at 12 weeks (end of double blind treatment period): invest. global assessment of dis. act. parent global assessment of overalll well-being, no. of active and swollen jts, functional disability index (CHAQ), ESR.

Secondary outcome: Each of the individual core set outcome criteria that makes up the ACR Ped 30, investigator and parent global assessment of efficacy, withdrawals due to inadequate efficacy and acetaminophen consumption (rescue medication)

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

Boehringer Ingelheim Investigational Site, Sao Paulo, Brazil

Instituto de Crianca / Hospital das Clínicas-FMUSP, Mooca / São Paulo, Brazil

Boehringer Ingelheim Investigational Site, Santa Cecília, Brazil

Boehringer Ingelheim Investigational Site, México, D.F., Mexico

Children Clinical Hospital No. 1, Kiev, Ukraine

Institute of Children and Adolescents Health, Kharkov, Ukraine

Institute of Pediatrics, Kiev, Ukraine

2nd Children Specialized Clinical Hospital "OHMADIT", Kiev, Ukraine

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

Attn: Kathy Schilling, Madera, California, United States

Boehringer Ingelheim Investigational Site, San Diego, California, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Attn: Denise Axsmith, Financial Analyst, Wilmington, Delaware, United States

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

Boehringer Ingelheim Investigational Site, Del Ray Beach, Florida, United States

Clinical Research Dept #7006, St. Petersberg, Florida, United States

Attn: Philip Soina, CRA, Chicago, Illinois, United States

University of Kansas Medical Center Research Institute, Inc., Kansas City, Kansas, United States

University of Louisville, Louisville, Kentucky, United States

Children's Hospital - Department of Rheumatology, New Orleans, Louisiana, United States

Deparment of Rheumatology, Boston, Massachusetts, United States

Mayo Clinic, Rochester, Minnesota, United States

St. Louis University, St. Louis, Missouri, United States

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

Attn: David Clouthier, Omaha, Nebraska, United States

Boehringer Ingelheim Investigational Site, Livingston, New Jersey, United States

Columbia University, New York, New York, United States

The Children's Hospital of Buffalo, Buffalo, New York, United States

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Duncansville, Pennsylvania, United States

Division of Ambulatory Pediatrics, Providence, Rhode Island, United States

Texas Scottish Rite Hospital, Dallas, Texas, United States

Boehringer Ingelheim Investigational Site, Salt LAke City, Utah, United States

Children's Hospital, Seattle, Washington, United States

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Starting date: November 2000
Ending date: May 2004
Last updated: April 23, 2008