An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT02552940
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUGParticipants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Study Details
This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.
Key Dates
- Start date
- Oct 31, 2015
- Status verified
- May 2018
- Primary completion
- Oct 23, 2017
- Completion
- Oct 23, 2017
Study Design
- Enrollment
- 140 participants (actual)
Arms
- Arm: Rheumatoid Arthritis participants treated with Tocilizumab SCParticipants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
Primary Outcome Measure
Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl) [ Time Frame: Up to Week 24 ]
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