A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

Sponsor
Hoffmann-La Roche
Study ID
NCT01617005
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Study Details

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

Key Dates

Start date
May 31, 2012
Status verified
Oct 2016
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
50 participants (actual)

Arms

  • Arm: Tocilizumab in Moderate to Severe Active RA
    Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to Week 24 ]

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