Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

February 28, 2010

Study Completion Date

August 31, 2010

Conditions
MyositisDermatomyositisPolymyositisJuvenile Dermatomyositis
Interventions
DRUG

Rituximab

Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Group B - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum does of 1 gram at Weeks 8 and 9

DRUG

Placebo

"Treatment Group A: placebo infusion at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"

Trial Locations (31)

10021

Hospital for Special Surgery (Adult Site), New York

11042

North Shore Long Island Jewish Health System (Adult Site), Lake Success

15213

Children's Hospital of Pittsburgh (Pediatric Site), Pittsburgh

15261

University of Pittsburgh / UPMC (Adult Site), Pittsburgh

19104

Children's Hospital of Philadelphia (Pediatric Site), Philadelphia

University of Pennsylvania (Adult Site), Philadelphia

20892

National Institute of Health (Adult Site), Bethesda

National Institute of Health (Pediatric Site), Bethesda

27710

Duke University Medical Center (Pediatric Site), Durham

33136

University of Miami School of Medicine (Adult Site), Miami

33155

Miami Children's Hospital (Pediatric Site), Miami

35294

University of Alabama Arthritis Intervention Program (Adult Site), Birmingham

40536

Kentucky Clinic (Adult Site), Lexington

45229

Cincinnati's Children's Hospital (Pediatric Site), Cincinnati

48109

University of Michigan Health System (Adult Site), Ann Arbor

49546

Michigan State University (Adult and Pediatric Site), Grand Rapids

53226

Medical College of Wisconsin / Froedtert Memorial Luthern Hospital (Adult Site), Milwaukee

55905

Mayo Clinic (Adult Site), Rochester

Mayo Clinic (Pediatric Site), Rochester

66160

University of Kansas Medical Center (Adult Site), Kansas City

85006

Phoenix Neurological Associates, LTD (Adult Site), Phoenix

90048

Cedars-Sinai Medical Center (Adult Site), Los Angeles

94305

Stanford University (Adult Site), Stanford

Stanford University (Pediatric Site), Stanford

02115

Children's Hospital of Boston (Pediatric Site), Boston

02215

Beth Israel Deaconess Medical Center (Adult Site), Boston

75390-8884

University of Texas Southwestern Medical Center (Adult), Dallas

B3K 6R8

IWK Health Centre, Halifax

M5G 1X8

Hospital for Sick Children (Pediatric Site), Toronto

Unknown

Institute of Rheumatology, Prague

Karolinska Institute, Stockholm

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

collaborator

Genentech, Inc.

INDUSTRY

collaborator

Biogen

INDUSTRY

lead

University of Pittsburgh

OTHER