An Observational Study of RoActemra/Actemra (Tocilizumab) in Rheumatoid Arthritis Patients
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01615419
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
- Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision
Exclusion Criteria
- RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- History of autoimmune disease or of any joint inflammatory disease other than RA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients on RoActemra/Actemra treatment at 6 months approximately 2 years
- Secondary Outcome Measures
Name Time Method Efficacy: Monotherapy versus combination therapy approximately 2 years Rates of dose modifications/interruptions approximately 2 years Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR approximately 2 years Use of disease-modifying anti-rheumatic drugs (DMARDs) approximately 2 years Clinical/demographic patient characteristics at initiation of treatment approximately 2 years