Rheumatoid Arthritis
Conditions
Brief summary
This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
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 * Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria * Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit. * Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed
Exclusion criteria
* Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics * Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit * Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use * Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra * Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra * History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients on RoActemra/Actemra at 6 months | approximately 20 months |
Secondary
| Measure | Time frame |
|---|---|
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment | approximately 20 months |
| Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR | approximately 20 months |
| Physician Global Assessment of disease activity | approximately 20 months |
| Rates of dose modifications/interruptions | approximately 20 months |
| Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) | approximately 20 months |
| Time to reduction/withdrawal of corticosteroids | approximately 20 months |
| Safety: Incidence of adverse events\n | approximately 20 months |
| Patient reported outcomes: Health Assessment Questionnaires | approximately 20 months |
Countries
Portugal
Outcome results
None listed