A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

May 10, 2005

Primary Completion Date

August 25, 2008

Study Completion Date

August 25, 2008

Conditions
Lupus Erythematosus, Systemic
Interventions
DRUG

Rituximab

Rituximab will be supplied as a sterile liquid for IV administration.

DRUG

Placebo

Placebo will be supplied as a sterile liquid for IV administration.

DRUG

Prednisone

DRUG

Acetaminophen

DRUG

Diphenhydramine

Trial Locations (65)

10003

NYU-Hosp for Joint Diseases; Rheum and Med, New York

10021

Hospital for Special Surgery, New York

11030

Feinstein Institute for Medical Research, Manhasset

11042

NS-LIJ Health Systems; Rheum-Allergy Clin Immu, Lake Success

11203

SUNY Downstate Medical Center., Brooklyn

11803

Long Island Osteo/Arth Center, Plainview

12206

Center for Rheumatology, State Uni. of New York, Albany

14127

Buffalo Rheumatology Associates, Orchard Park

14642

University of Rochester - Strong Memorial Hospital, Rochester

15213

University of Pittsburgh, Pittsburgh

16635

Altoona Arthritis & Osteo Center, Duncansville

18015

East Penn Rheumatology Associates, Pc, Bethlehem

19104

Uni of Pennslyvania Medical Center, Philadelphia

19141

Albert Einstein Medical Center, Philadelphia

20902

Center For Rheumatology & Bone Research, Wheaton

21205

Johns Hopkins Uni, Baltimore

22908

University of Virginia Med Ctr; Div of Ped Respiratory Med, Charlottesville

23298

Virginia Commonwealth University, Richmond

27514

University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services, Chapel Hill

27710

Duke Medical Center, Durham

27834

Physicians East Pa, Greenville

29425

Medical Univ of South Carolina, Charleston

30303

Emory Uni ; Division of Rheumatology, Atlanta

33180

Arthritis & Rheumatism; Disease Specialities, Aventura

33458

Family Arthritis Center, Jupiter

35294

Univ of Alabama School of Med; Clinical Immun Rheumatology, Birmingham

35801

Rheumatology Assoc of North AL, Huntsville

37404

Arthritis Associates PLLC, Chattanooga

40202

Kentuckiana Cancer Institute, Louisville

43210

Ohio State University; Division of Nephrology, Columbus

47714

Tri-State Arth & Rheum Center, Evansville

48109

University Of Michigan, Ann Arbor

48116

Michigan Arthritis Rsrch Ctr, Brighton

60611

Northwestern University, Chicago

60612

Rheumatology Associates, Chicago

60637

University of Chicago, Chicago

63110

Washington University; Rheumatology Division, St Louis

66160

Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum, Kansas City

71103

LA State Univ; Medicine, Shreveport

73103

Bone and Joint Hospital at St. Anthony Research Department, Oklahoma City

73104

Oklahoma Medical Research Foundation, Oklahoma City

74104

Oklahoma Center For Arthritis Therapy & Research, Tulsa

75231

Metroplex Clinical Research, Dallas

75246

Arthritis Centers of Texas, Dallas

77074

Houston Inst. For Clinical Research, Houston

77479

Texas Research Center, Sugar Land

79424

Arthritis & Osteoporosis Associates, LLP, Lubbock

80045

University of Colorado Denver, Aurora

83702

Intermountain Research Center, Boise

83814

Coeur D'Alene Arthritis Clinic, Coeur d'Alene

85253

Arizona Arthritis & Rheumatology Research, Pllc, Paradise Valley

90025

Univ of Calif., Los Angeles; Rheumatology, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

92037

Univ of California, San Diego, La Jolla

94304

Stanford University Med Ctr;Div of Immunology/Rheumatology, Palo Alto

94578

Eden Medical Center San Leandro Hospital, San Leandro

97224

Portland Medical Associates, Portland

98104

Seattle Rheumatology Assoc; Swedish Rheumatology Research, Seattle

98109

Seattle Cancer Care Alliance, Seattle

99204

Arthritis Northwest, Spokane, Spokane

94143-0111

Univ of Calif, San Francisco; Rheumatology, San Francisco

02111

Tufts - New England Medical Center, Boston

02215-5501

Dana-Farber Cancer Institute; Rheumatology, Boston

R3A1M4

Univ of Manitoba, Health Scien; Arthritis Centre, Winnipeg

N6A 4V2

St. Joseph'S Health Care Centre, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT00137969 - A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter