Rheumatoid Arthritis Clinical Trial
Official title:
Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program
This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in patients with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Patients who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 mg intravenously on Days 1 and 15 will be followed for 20 weeks.
Status | Completed |
Enrollment | 505 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Patients with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with SPC - Inadequate response to a single TNF inhibitor defined as change in DAS28-ESR <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy - Patients with a clinical and biological evaluation performed within 12 weeks prior to enrolment may be included Exclusion Criteria: - More than one previous anti-TNF therapies - Any other biological therapy apart from the one anti-TNF therapy - Hypersensitivity to rituximab or any of the excipients or to murine proteins - Active severe infections - Patients in a severely immunocompromised state - Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease - Women of childbearing potential not willing to use contraception - Pregnant or breastfeeding women - Participation in another trial |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in Disease Activity Score (DAS28-ESR) at Week 20 | approximately 2 years | No | |
Primary | Safety: Incidence of adverse events | approximately 2 years | No | |
Secondary | Quality of life: Health Assessment Questionnaire | approximately 2 years | No |
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