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

This study is currently recruiting participants.
Verified September 2010 by PerCuro Clinical Research Ltd
Sponsor:
Information provided by:
PerCuro Clinical Research Ltd
ClinicalTrials.gov Identifier:
NCT00984711
First received: September 23, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with active rheumatoid arthritis

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984711

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

Locations
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
Investigators
Principal Investigator: Christopher Atkins, MD PerCuro Clinical Research Ltd
  More Information

No publications provided

Responsible Party: Christopher Atkins MD, PerCuro Clinical Research Ltd.
ClinicalTrials.gov Identifier: NCT00984711     History of Changes
Other Study ID Numbers: ML21427
Study First Received: September 23, 2009
Last Updated: September 23, 2010
Health Authority: Canada: Western Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013