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

This study is currently recruiting participants. (see Contacts and Locations)
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

September 23, 2009
September 23, 2010
May 2007
May 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00984711 on ClinicalTrials.gov Archive Site
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Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects with active rheumatoid arthritis

Rheumatoid Arthritis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Leeanna Bulinckx, RN, BScN 250-382-6270
Contact: Chantal Vaillancourt, RN, BScN 250-382-6270
Canada
 
NCT00984711
ML21427
No
Christopher Atkins MD, PerCuro Clinical Research Ltd.
PerCuro Clinical Research Ltd
Not Provided
Principal Investigator: Christopher Atkins, MD PerCuro Clinical Research Ltd
PerCuro Clinical Research Ltd
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP