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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Tocilizumab in RA patient treatment?
How does Tocilizumab compare to TNF inhibitors in managing rheumatoid arthritis?
Which biomarkers predict response to Tocilizumab in RA patients?
What are the adverse events associated with Tocilizumab in RA clinical practice?
Are there combination therapies with Tocilizumab for RA that improve efficacy?