Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Biogen Idec |
---|---|
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00771043 |
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
Condition | Intervention | Phase |
---|---|---|
Relapsing-Remitting Multiple Sclerosis |
Drug: TYSABRI and AVONEX |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a |
Estimated Enrollment: | 50 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TYSABRI: No Intervention |
Drug: TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.
|
AVONEX: No Intervention |
Drug: TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Research Site | |
Los Angeles, California, United States, 90033 | |
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, O6510 | |
United States, Maryland | |
Research Site | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Research Site | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Research Site | |
East Lansing, Michigan, United States, 48824 | |
United States, Mississippi | |
Research Site | |
Jackson, Mississippi, United States, 39216 | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19104 | |
Research Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Research Site | |
Dallas, Texas, United States, 75390 |
Responsible Party: | Biogen Idec ( Richard Kim, MD ) |
Study ID Numbers: | US 010-07-NAT |
Study First Received: | October 7, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00771043 |
Health Authority: | United States: Institutional Review Board |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta 1a Interferon-beta |
Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Antiviral Agents Pharmacologic Actions |