Rheumatoid Arthritis Clinical Trial
Official title:
Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ministry of Social Affairs and Health |
Study type | Observational |
This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.
Status | Completed |
Enrollment | 151 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients, >/= 18 years of age - rheumatoid arthritis - treatment with rituximab Exclusion Criteria: - unable/unwilling to give informed consent to data collection |
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 | Efficacy: DAS28 | 29 months | No | |
Secondary | Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) | 29 months | No | |
Secondary | Safety: serious and non-serious adverse events | 29 months | No |
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