A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT02693210
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
  • Methotrexate — DRUG
    Participants will receive \>= 10 mg/week methotrexate orally up to 24 weeks
  • Placebo Cyclophosphamide — OTHER
    Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
  • Placebo Methotrexate — OTHER
    Participants will receive weekly oral placebo in place of Methotrexate
  • Placebo Rituximab — OTHER
    Participants will receive placebo in place of rituximab on days 1 and 15
  • Rituximab — DRUG
    Participants will receive 1g infusions of rituximab on Days 1 and 15

Study Details

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.

Key Dates

Start date
Feb 28, 2001
Status verified
Oct 2016
Primary completion
Aug 31, 2002
Completion
Aug 31, 2004

Study Design

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

Arms

  • Active Comparator: Group A: Methotrexate
    Participants will receive methotrexate at dosage \>=10 milligrams per week (mg/week) orally as determined by the investigator. They also receive placebo infusion on days 1 and 15 in place of rituximab and on Days 3 and 17 in place of cyclophosphamide.
  • Experimental: Group B: Rituximab Monotherapy
    Participants will receive 1 g intravenous infusions of rituximab on Days 1 and 15. They also receive Weekly placebo orally instead of methotrexate and placebo infusion in place of cyclophosphamide on Days 3 and 17.
  • Experimental: Group C: Rituximab and Cyclophosphamide
    Participants will receive 1g IV infusion of rituximab on Days 1 and 15 and 750 mg infusion of Cyclophosphamide on Days 3 and 17. They also receive weekly oral placebo in place of methotrexate.
  • Experimental: Group D: Methotrexate and Rituximab
    Participants will receive \>=10 mg/week methotrexate orally along with 2 times 1 gram (g) rituximab IV infusions on Days 1 and 15. Participants will also receive placebo infusions on Days 3 and 17 in place of cyclophosphamide.

Primary Outcome Measure

Percentage of participants achieving American College of Rheumatology (ACR) 50 response at Week 24 [ Time Frame: Week 24 ]

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