A Retrospective Observational Study on the Use of Biologics in Monotherapy in Patients With Rheumatoid Arthritis
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01834807
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This retrospective, observational, multi-center study will evaluate the use of biological agents (e.g. RoActemra/Actemra \[tocilizumab\]) in monotherapy in patients with rheumatoid arthritis. Data from medical record files will be collected of patients currently treated with a biologic in monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Diagnosis of rheumatoid arthritis
- Currently receiving a biologic agent in monotherapy (corticosteroids and/or non-steroidal anti-inflammatory drugs are permitted)
Exclusion Criteria
- Concomitant treatment with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis
- Patients that have started their current monotherapy before 01/01/2009
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment schedule/duration of biological agents used in monotherapy in routine clinical practice approximately 1 year Type of biological agents used in monotherapy in routine clinical practice approximately 1 year
- Secondary Outcome Measures
Name Time Method Quality of life: HAQ-DI score approximately 1 year Efficacy: Response according to DAS28-ESR/CRP, CDAJ/SDAI, SJC (28) and TJC (28) and other parameters of composite scores approximately 1 year Safety of biologics used in monotherapy: Incidence of adverse events approximately 1 year