A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

Sponsor
Genentech, Inc.
Study ID
NCT00299130
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Folate — DRUG
    A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
  • Methotrexate — DRUG
    A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
  • Methylprednisolone — DRUG
    Intravenous infusion
  • Placebo — DRUG
    Placebo to rituximab intravenous infusion
  • Rituximab — DRUG
    Intravenous infusion

Study Details

This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).

Key Dates

Start date
Oct 31, 2005
Status verified
Mar 2017
Primary completion
Jun 30, 2008
Completion
Jul 31, 2013

Study Design

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

Arms

  • Active Comparator: Placebo + methotrexate (MTX)
    Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
  • Experimental: Rituximab 2 x 0.5 g + MTX
    Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
  • Experimental: Rituximab 2 x 1.0 g + MTX
    Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

Primary Outcome Measure

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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