A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01462162
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.

Key Dates

Start date
Sep 30, 2011
Status verified
Sep 2016
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
122 participants (actual)

Arms

  • Arm: Rheumatoid Arthritis Participants
    Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center will be followed-up for 6 months.

Primary Outcome Measure

Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 [ Time Frame: Week 12 ]

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