An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Sponsor
Hoffmann-La Roche
Study ID
NCT01641952
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Study Details

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.

Key Dates

Start date
Oct 31, 2011
Status verified
Jul 2016
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
505 participants (actual)

Arms

  • Arm: Rituximab
    Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Primary Outcome Measure

Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria [ Time Frame: Week 20 ]

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