Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis

Sponsor
Frank Behrens
Study ID
NCT01244958
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    1000 mg Rituximab infusion
  • Placebo — DRUG
    infusion of Sodium citrate, Polysorbate, Sodium chloride

Study Details

Combination of rituximab (RTX) with several different chemotherapeutic regimes has proven synergistic effects in patients with either lymphoma or autoimmune diseases. First data of uncontrolled trials with the combination of RTX and leflunomide (LEF) are available.

Key Dates

Start date
Aug 31, 2010
Status verified
Mar 2016
Primary completion
Feb 28, 2015
Completion
Feb 28, 2015

Study Design

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

Arms

  • Active Comparator: Rituximab 1000 mg
    Administration of 1000 mg Rituximab in Part I, followed by either re-treatment with 1000 mg Rituximab or with 500 mg Rituximab in Part II of the study
  • Placebo Comparator: Placebo
    Administration of Placebo in Part I followed by re-treatment with either 1000 mg Rituximab or with 500 mg Rituximab in Part II of the study

Primary Outcome Measure

ACR 50 - Part I of the Study - 50% improvement of ACR defined disease activity [ Time Frame: Week 24 ]

Related Studies