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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by PerCuro Clinical Research Ltd.
Recruitment status was:  Recruiting
Information provided by:
PerCuro Clinical Research Ltd Identifier:
First received: September 23, 2009
Last updated: September 23, 2010
Last verified: September 2010
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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by PerCuro Clinical Research Ltd:

Estimated Enrollment: 150
Study Start Date: May 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Christopher Atkins MD, PerCuro Clinical Research Ltd. Identifier: NCT00984711     History of Changes
Other Study ID Numbers: ML21427
Study First Received: September 23, 2009
Last Updated: September 23, 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 processed this record on September 21, 2017