GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

PHASE3CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

August 31, 2005

Study Completion Date

August 31, 2005

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Prasterone (GL701)

"There were 4 arms to the study:~During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study."

Trial Locations (22)

10461

Albert Einstein Medical School, The Bronx

11030

North Shore University Hospital, Division of Rheumatology, Manhasset

11203

SUNY Downstate Medical Center, Brooklyn

14000

Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z., Mexico City

15261

University of Pittsburgh, Pittsburgh

16635

Altoona Center for Clinical Research, Duncansville

21205

Johns Hopkins University, Baltimore

23462

Sentara Medical Group DBA, Virginia Beach

33334

Center for Rheumatology, Immunology and Arthritis, Fort Lauderdale

33614

Tampa Medical Group, P.A., Tampa

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

65804

St. John's Medical Research Group, Springfield

74114

Oklahoma Center for Arthritis Therapy, Tulsa

85724

University of Arizona, Tucson

90048

Wallace Rheumatic Study Center, Los Angeles

92270

Lifestyles Health Science Center, Rancho Mirage

94578

East Bay Rheumatology Group, San Leandro

97201

Oregon Health & Science University, Portland

98104

Seattle Rheumatology Associates, Seattle

92093-0943

University of California San Diego, San Diego

32806-6264

Rheumatology Associates of Central Florida, Orlando

Sponsors
All Listed Sponsors
lead

Genelabs Technologies

INDUSTRY