Rheumatoid Arthritis Clinical Trial
Official title:
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Verified date | December 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients initiated on treatment with RoActemra/Actemra according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
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 revised (1987) ACR criteria - Initiated on RoActemra/Actemra treatment by the treating physician in accordance with the Canadian product monograph - Informed consent to data being subject to computerized data processing - Patient must fulfill the reimbursement criteria for treatment with RoActemra/Actemra under provincial or private health insurance coverage Exclusion Criteria: - Received RoActemra/Actemra prior to enrolment visit - Previously received RoActemra/Actemra in a clinical trial or for compassionate use - Enrolled in an ongoing clinical trial and/or received 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 - Participation in another clinical trial or industry sponsored observational study - History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients on RoActemra/Actemra treatment at Month 6 | approximately 21 months | No | |
Secondary | Percentage of patients on RoActemra/Actemra treatment at Month 12 | approximately 21 months | No | |
Secondary | Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment | approximately 21 months | No | |
Secondary | Rates of dose modifications/interruptions | approximately 21 months | No | |
Secondary | Change in total swollen and tender joint counts | from baseline to Month 12 | No | |
Secondary | Change in disease activity score (DAS 28) | from baseline to Month 12 | No | |
Secondary | Change in patient assessment of disease activity/pain/fatigue (VAS) | from baseline to Months 12 | No | |
Secondary | Change in physician global assessment of disease activity (VAS) | from baseline to Month 12 | No | |
Secondary | Change in duration of morning stiffness | from baseline to Month 12 | No | |
Secondary | Change in C-reactive protein/ESR | from baseline to Month 12 | No | |
Secondary | Percentage of patients achieving therapeutic response according to DAS28/EULAR/SDAI/CDAI criteria | approximately 21 months | No | |
Secondary | Use of concomitant medication (DMARDs, NSAIDs, corticosteroids) | approximately 21 months | No | |
Secondary | Efficacy: monotherapy versus combination therapy | approximately 21 months | No | |
Secondary | Safety: Incidence of adverse events | approximately 21 months | No | |
Secondary | Change in Quality of life: HAQ/MOS SF-36/Work Limitations Questionnaires | from baseline to Month 12 | No |
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