Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT02101307
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Patients at least 18 years of age
- Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria
- Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- Patient has given informed consent
- 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
- Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation 6 months
- Secondary Outcome Measures
Name Time Method Proportion of patients with systemic manifestation of RA At Baseline Efficacy as assessed by total joint count evaluation 6 months Health-related quality of life as assessed by questionnaire 6 months Treatment patterns during observation period, assessed by alteration in dosing regimen 6 months Record of RA treatment history 6 months Incidence of adverse events 6 months
Trial Locations
- Locations (25)
Peking University First Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
Beijing Union Hospital
🇨🇳Beijing, China
Xiangya Hospital of Centre-South University
🇨🇳Changsha, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Southwest Hospital , Third Military Medical University
🇨🇳Chongqing, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, China
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