A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

PHASE2CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

January 23, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

May 28, 2012

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Rituximab

Rituximab was supplied in single-use vials.

DRUG

Methotrexate

DRUG

Methylprednisone

Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.

BIOLOGICAL

C. albicans

Patients received an intradermal injection of C. albicans (0.1 mL) on the volar surface of the forearm.

BIOLOGICAL

Tetanus toxoid adsorbed booster vaccine

Patients received an intramuscular injection of the tetanus toxoid adsorbed booster vaccine (1 mg in 0.5 mL) in the deltoid muscle.

BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Patients received an intramuscular injection of the 23-valent pneumococcal polysaccharide vaccine (0.5 mL) in the deltoid muscle.

BIOLOGICAL

Keyhole limpet hemocyanin

Patients received a subcutaneous injection of keyhole limpet hemocyanin (1 mg)

Trial Locations (34)

12206

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

14618

Aair Research Center, Rochester

14642

University of Rochester - Strong Memorial Hospital, Rochester

16635

Altoona Arthritis & Osteo Center, Duncansville

19104

University of Pennsylvania, Philadelphia

21224

Johns Hopkins University; Rheumatology, Baltimore

22205

Arthritis Clinic of Northern Virginia, Arlington

27834

Physicians East Pa, Greenville

29407

Rheumatology Associates, Charleston

29425

Medical University of S. Carolina, Charleston

33143

Center For Arthritis; Research Dept, South Miami

33484

Arthritis Associates of South Florida, Delray Beach

34684

The Arthritis Center, Palm Harbor

35294

Univ of Alabama at Birmingham, Birmingham

37343

Arthritis Associates, Hixson

40202

Kentuckiana Center For Better Bone & Joint Healthx, Louisville

48910

Justus Fiechtner MD - PP, Lansing

49009

Rheumatology, P.C.; Medical Arts Building, Kalamazoo

49048

Borgess Research Institute, Kalamazoo

60611

Northwestern University, Chicago

60637

Univ of Chicago, Chicago

62703

Springfield Clinic, Springfield

70458

Clinical Research Network, Slidell

73103

Health Research of Oklahoma, Llc, Oklahoma City

83702

Intermountain Orthopaedics, Boise

85253

Arizona Arthritis & Rheumatology Research, Pllc, Paradise Valley

85381

Sun Valley Arthritis Center, Peoria

91786

Inland Rheumatology; Clinical Trials, Inc., Upland

92260

Desert Medical Advances, Palm Desert

97239

Oregon Health Sciences Uni, Portland

99204

Arthritis Northwest, Spokane, Spokane

Unknown

Evanston Northwestern Healthcare, Evanston

02215

Dana Farber Cancer Institute, Boston

75231-4406

Arthritis Care & Diagnostic Center, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY