Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IV, Post-marketing, Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice
This study was designed to gather data regarding the efficacy and safety of Rituxan in clinical practice whereby patients may present with concomitant medical conditions, medications as well as varying presentations of rheumatoid arthritis not always captured within the "purer" population seen in an industry sponsored clinical trial.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects with active rheumatoid arthritis as defined by ACR criteria - > 18 years of age at time of consent - Able to start RITUXAN therapy per the approved product monograph within approximately 30 days of confirmed enrollment Exclusion Criteria: - Known Type 1 hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary cell proteins or to any component of RITXAN as per approved Product monograph - Presence of any significant and or uncontrolled medical condition, which in the Investigator's opinion, precludes the use of RITUXAN as outlined in the Product Monograph |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | PerCuro Clinical Research Ltd. | Victoria | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| PerCuro Clinical Research Ltd |
Canada,
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