Rheumatoid Arthritis Clinical Trial
Official title:
An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Observational |
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.
Status | Completed |
Enrollment | 51 |
Est. completion date | May 2014 |
Est. primary completion date | May 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 - Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011 Exclusion Criteria: - RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B - Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients on RoActemra/Actemra treatment at 6 months | approximately 2.5 years | No | |
Secondary | Rates of dose modifications/interruptions | approximately 2.5 years | No | |
Secondary | Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment | approximately 2.5 years | No | |
Secondary | Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR | approximately 2.5 years | No | |
Secondary | Efficacy: Monotherapy versus combination therapy | approximately 2.5 years | No | |
Secondary | Safety: Incidence of adverse events | approximately 2.5 years | No | |
Secondary | Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales | approximately 2.5 years | No |
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