An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01071798
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).

Key Dates

Start date
Jan 31, 2010
Status verified
Jan 2016
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
1,653 participants (actual)

Arms

  • Arm: Main Analysis Set
    Participants who received at least one cycle of rituximab

Primary Outcome Measure

DAS28 Score [ Time Frame: at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle ]

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