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:
PerCuro Clinical Research Ltd
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 23, 2009 | ||||||||
| Last Updated Date | September 23, 2010 | ||||||||
| Start Date ICMJE | May 2007 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00984711 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice | ||||||||
| Official Title ICMJE | A Phase IV, Post-marketing, Observational Study of Rituxan in Rheumatoid Arthritis Patients in Routine Clinical Practice | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Subjects with active rheumatoid arthritis |
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| Condition ICMJE | Rheumatoid Arthritis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 19 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00984711 | ||||||||
| Other Study ID Numbers ICMJE | ML21427 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christopher Atkins MD, PerCuro Clinical Research Ltd. | ||||||||
| Study Sponsor ICMJE | PerCuro Clinical Research Ltd | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | PerCuro Clinical Research Ltd | ||||||||
| Verification Date | September 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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