Rheumatoid Arthritis
Conditions
Brief summary
This prospective, multi-center observational study will assess the long-term efficacy and safety of RoActemra/Actemra in daily practice in patients with active moderate to severe rheumatoid arthritis who have an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. Data will be collected from patients initiated on RoActemra/Actemra treatment according to label by decision of the treating physician. Anticipated time for data collection from each patient will be 2 years.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Active moderate to severe rheumatoid arthritis * Inadequate response or intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists * Prescription of RoActemra/Actemra according to label
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with clinical remission defined as disease activity score DAS28 < 2.6 | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with good or moderate response according to EULAR criteria | 5 years |
| Time to good or moderate response according to EULAR criteria | 5 years |
| Factors related to response (C-reactive protein, rheumatoid factor, inadequate response to DMARDs or anti-TNF, duration of illness) | 5 years |
| Time to DAS28 remission | 5 years |
| Safety: Incidence of adverse events | 5 years |
| Efficacy of other possible RA therapies in case of inadequate response to RoActemra/Actemra (DAS28, EULAR criteria) | 5 years |
| Safety of other possible RA therapies in case of inadequate response to RoActemra/Actemra (adverse events) | 5 years |
| Dose-modifications and discontinuations of RoActemra/Actemra | 5 years |
Countries
Germany
Outcome results
None listed