A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)
Terminated
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01643863
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients on RoActemra/Actemra at 6 months approximately 20 months
- Secondary Outcome Measures
Name Time Method Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment approximately 20 months Rates of dose modifications/interruptions approximately 20 months Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) approximately 20 months Safety: Incidence of adverse events\n approximately 20 months Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR approximately 20 months Patient reported outcomes: Health Assessment Questionnaires approximately 20 months Time to reduction/withdrawal of corticosteroids approximately 20 months Physician Global Assessment of disease activity approximately 20 months