An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01613027
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — BIOLOGICAL
    Rituximab administered according to prescribing information and normal clinical practice.

Study Details

This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.

Key Dates

Start date
Feb 29, 2012
Status verified
Aug 2016
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
135 participants (actual)

Arms

  • Arm: Rituximab
    Rituximab administered according to prescribing information and normal clinical practice.

Primary Outcome Measure

Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 [ Time Frame: Baseline, Month 6, Month 12 ]

Related Studies