Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

PHASE2TerminatedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

July 31, 2011

Conditions
Rheumatoid Arthritis
Interventions
BIOLOGICAL

IDEC-C2B8 (rituximab)

Participants will receive 500 mg rituximab on Day 1 and Day 15

DRUG

Placebo

Participants will receive placebo on Day 1 and Day 15

DRUG

Methotrexate

Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for at least 12 weeks immediately prior to Day 1, at a stable dose for at least 4 weeks and was continued for the study duration.

DRUG

Etanercept

Participants must have been treated with etanercept at 50 mg per week (25 mg twice per week or 50 mg once per week).

DRUG

Adalimumab

Participants must have been treated with adalimumab at 40 mg every other week for at least 12 weeks immediately prior to Day 1.

DRUG

Methylprednisolone

Methylprednisolone 100 mg IV was administered by slow infusion to be completed at least 30 minutes prior to each infusion of rituximab or placebo.

DIETARY_SUPPLEMENT

Folate

All subjects also received a stable dose of folate (≥5 mg per week).

Trial Locations (18)

16635

Research Site, Duncansville

33458

Research Site, Jupiter

34239

Research Site, Sarasota

35801

Research Site, Huntsville

44024

Research site, Chardon

44143

Research Site, Mayfield Village

49048

Research Site, Kalamazoo

63141

Research Site, St Louis

73103

Research Site, Oklahoma City

74135

Research Site, Tulsa

75231

Research Site, Dallas

77074

Research Site, Houston

78217

Research Site, San Antonio

83702

Research Site, Boise

84132

Research Site, Salt Lake City

85253

Research Site, Paradise Valley

92260

Research Site, Palm Desert

05401

Research Site, Burlington

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

Biogen

INDUSTRY