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Clinical Trials/NCT01075477
NCT01075477
Completed
Not Applicable

Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Hoffmann-La Roche0 sites151 target enrollmentSeptember 2009
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ConditionsRheumatoid Arthritis
Interventionsrituximab [Mabthera/Rituxan]
Drugsrituximab [Mabthera/Rituxan]

Overview

Phase
Not Applicable
Intervention
rituximab [Mabthera/Rituxan]
Conditions
Rheumatoid Arthritis
Sponsor
Hoffmann-La Roche
Enrollment
151
Primary Endpoint
Efficacy: DAS28
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2011
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •adult patients, \>/= 18 years of age
  • •rheumatoid arthritis
  • •treatment with rituximab

Exclusion Criteria

  • •unable/unwilling to give informed consent to data collection

Arms & Interventions

Cohort

Intervention: rituximab [Mabthera/Rituxan]

Outcomes

Primary Outcomes

Efficacy: DAS28

Time Frame: 29 months

Secondary Outcomes

  • Safety: serious and non-serious adverse events(29 months)
  • Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS)(29 months)

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