Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Sponsor
Hoffmann-La Roche
Study ID
NCT02809833
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab must be selected by the treating physician in advance of the study and will be not provided by the Sponsor. The dose/regimen are at the discretion of the prescriber. However, tocilizumab in the SmPC is specified as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.

Study Details

This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.

Key Dates

Start date
Jan 31, 2009
Status verified
Aug 2016
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
850 participants (actual)

Arms

  • Arm: Tocilizumab for RA in Routine Practice
    Participants from routine clinical practice in Germany who are receiving tocilizumab for RA according to SmPC are eligible.

Primary Outcome Measure

Percentage of Participants With Categorized Laboratory Data Available at Baseline [ Time Frame: Baseline ]

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