Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy

Sponsor
Hoffmann-La Roche
Study ID
NCT01362062
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.

Key Dates

Start date
Oct 26, 2010
Status verified
Jun 2017
Primary completion
Jan 1, 2015
Completion
Jan 1, 2015

Study Design

Enrollment
110 participants (actual)

Arms

  • Arm: RA Cohort
    Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information will be observed for a total duration of 12 months.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Up to 12 months ]

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