An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT01384461
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)
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Exclusion Criteria
- History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
- Active, severe infection or history of recurrent clinically significant infection
- Pregnancy
- Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
- Methotrexate intolerance
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events 12 months
- Secondary Outcome Measures
Name Time Method Pain: Visual Analogue Scale (VAS) pain scale 12 months Physical Function: Health Assessments Questionnaire (HAQ) 12 months Efficacy: Disease Activity Score (DAS 28) 12 months Incidence of patients with all-cause discontinuation of tocilizumab 12 months