Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Biogen Idec |
---|---|
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00818038 |
A recent report has demonstrated improvements in QoL parameters in patients receiving TYSABRI® (Rudick et al, 2007). This observation, coupled with anecdotal reports and our own experience, lead us to hypothesize that TYSABRI® will have a demonstrable beneficial effect on improving patient's bladder function as defined by changes in baseline to month 6 scores on the UDI-6 and also on patient reported incontinence episodes and micturitions per day.
Condition |
---|
Relapsing Remitting Multiple Sclerosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of Bladder Function in Relapsing Remitting Multiple Sclerosis Patients Treated With Natalizumab (TYSABRI) |
Estimated Enrollment: | 30 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
TYSABRI naive
Patients who are newly prescribed TYSABRI®, but have not received their first infusion, will be invited to participate.
|
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Men and women 18 years or older with relapsing remitting multiple sclerosis who have never received an infusion of TYSABRI.
Inclusion Criteria:
Patients are eligible to be screened for this study if all of the following criteria are met:
Patients will be selected for enrollment if all of the following criteria are met:
Screening Visit urinary incontinence defined as:
Exclusion Criteria:
Candidates will be excluded from study screening if any of the following exclusion criteria exist:
Patients will be determined as screen failures if any of the following criteria apply:
Abnormal blood tests, performed at the screening visit, which exceed any of the limits defined below:
United States, Utah | |
John Foley, MD | Recruiting |
Salt Lake City, Utah, United States, 84103 | |
Contact: Olivia Derridinger 801-408-4584 | |
United States, Wisconsin | |
Bhupendra Khatri, MD | Recruiting |
Milwaukee, Wisconsin, United States, 53215 | |
Contact: Jennifer Fink 414-649-5097 |
Responsible Party: | Biogen Idec, Inc ( Richard Kim, MD ) |
Study ID Numbers: | US 006-08-NAT |
Study First Received: | January 5, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00818038 History of Changes |
Health Authority: | United States: Institutional Review Board |
MS RRMS Relapsing Remitting |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |