Rheumatoid Arthritis Clinical Trial
Official title:
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Observational |
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.
Status | Completed |
Enrollment | 183 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline - RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing - Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis Exclusion Criteria: - Rheumatic autoimmune disease other than RA - Participation in interventional clinical trials during the observational period |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment | 12 months | No | |
Secondary | Frequency of withdrawal (according to reasons) | 12 months | No | |
Secondary | Frequency of dose modifications | 12 months | No | |
Secondary | Change in disease activity (DAS28) | from baseline to Month 6 or withdrawal, whichever comes first | No |
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