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Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice

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ClinicalTrials.gov Identifier: NCT00984711
Recruitment Status : Unknown
Verified September 2010 by PerCuro Clinical Research Ltd.
Recruitment status was:  Recruiting
First Posted : September 25, 2009
Last Update Posted : September 24, 2010
Information provided by:
PerCuro Clinical Research Ltd

Brief Summary:
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.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Post-marketing, Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice
Study Start Date : May 2007
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with active rheumatoid arthritis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984711

Contact: Leeanna Bulinckx, RN, BScN 250-382-6270
Contact: Chantal Vaillancourt, RN, BScN 250-382-6270

Canada, British Columbia
PerCuro Clinical Research Ltd. Recruiting
Victoria, British Columbia, Canada, V8V 3P9
Principal Investigator: Christopher J Atkins, MD         
Sponsors and Collaborators
PerCuro Clinical Research Ltd
Principal Investigator: Christopher Atkins, MD PerCuro Clinical Research Ltd

Responsible Party: Christopher Atkins MD, PerCuro Clinical Research Ltd.
ClinicalTrials.gov Identifier: NCT00984711     History of Changes
Other Study ID Numbers: ML21427
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents