A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

Sponsor
Genentech, Inc.
Study ID
NCT00266227
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • placebo — DRUG
    Intravenous repeating dose
  • rituximab — DRUG
    Intravenous repeating dose
  • methotrexate — DRUG
    Oral or parenteral repeating dose
  • folate — DRUG
    Intravenous repeating dose

Study Details

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX).

Key Dates

Start date
Jan 31, 2006
Status verified
Sep 2013
Primary completion
Oct 31, 2007

Study Design

Enrollment
559 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Rituximab Retreatment
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
  • Placebo Comparator: Arm B: Placebo Retreatment
    1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.

Primary Outcome Measure

Retreated Subjects With an American College of Rheumatology 20% (ACR20) Response at Week 48 Relative to Baseline [ Time Frame: 48 Weeks ]

Related Studies