Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Medicine and Dentistry New Jersey |
---|---|
Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00176592 |
This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Betaserone or Copaxone, MRI and Gadolinum |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Phase IV, Rater-Blinded, Randomized Study, Comparing the Effects of 250 Mg of Betaseron With 20 Mg of Copaxone in Patients With the Relapsing-Remitting or Clinically Isolated Forms of Multiple Sclerosis Using 3 Tesla MRI With Triple-Dose Gadolinium |
Estimated Enrollment: | 75 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | January 2006 |
We propose to perform a head to head comparison of Interferon beta and Copaxone for treatment of patients with CIS and RR forms of MS using acute changes on MRI as primary outcome. The study will be performed at the two clinical practice sites of the Multiple Sclerosis Center at UMDNJ-New Jersey Medical School, One of the two FDA approved preparations of higher dose interferon beta (Betaseron) will be compared at standard dose (250 ug SQ QOD) with Copaxone (at 20mg SC QD) in 70 to 80 patients. Although the current approved plan is to perform monthly MRIs for 1 year followed by another MRI at 2 years, the protocol has been changed to continue performing monthly MRIs during the second year of the study for all patients who complete their first year and up to January 31, 2006 when the study will end. The study uses brain imaging with 3 Tesla MRI with triple dose Gadolinium for primary and secondary outcomes and several clinical and cognitive measures for secondary outcomes. The sample size was estimated to detect a 40-50% difference in the number of active MS lesions by MRI between the two arms at 1 year follow up, consistent with the primary outcome measure. The primary outcome measure is the number of
Another MRI outcome measures will be detection of diffusion anisotropy differences, MR spectroscopy, and magnetization transfer ratio as summarized in Appendix 5. These new techniques have shown promise for detecting disease that cannot be detected with conventional MRI (13, 37). In addition to MRI, several clinical and cognitive outcome measures will be used for secondary analysis. These include the number and severity of relapses measured by different methods, and change in disability measured by the Expanded Disability Status Scale (EDSS), the Scripps Neurological Rating Scale, and the Multiple Sclerosis Functional Composite (MSFC). The cognitive measures will be the subject’s neurocognitive function measured by standard neurocognitive examination obtained by a licensed neuropsychologist and the Cognitive Stability Index (CSI), a novel Internet-based test of cognitive function in addition to the PASAT (which is a component of the MSFC).
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients must meet all of the following criteria at the time of the baseline visit in order to enter the trial:
Presently meet one of the two following forms of multiple sclerosis:
A clinically isolated syndrome consistent with CNS demyelination confirmed on ophthalmologic or neurological examination with onset within 6 months prior to study entry. In addition, the following two criteria should be met: a- As evidence of dissemination in space, there should be two or more brain MRI lesions ≥ 3 mm in size at least one of which should be ovoid and/or periventricular in location; and b- As evidence of dissemination in time, if the CIS is acute (≤1 month) there should be one or more non-enhancing lesion or if the CIS is not acute (older than 1 month) the MRI should show one or more enhancing lesions.
7.3.2 Exclusion criteria
Patients were not permitted into the study if they met any of the following criteria:
Table 2. Prohibited treatments and washout periods
Washout Period Treatment(s) No use for at least one year before entry into the study · Any of the Interferons for > 6 months· Glatiramer acetate (Copaxone) for > 6 months. No prior use allowed · Total lymphoid irradiation· Anti-lymphocyte monoclonal antibody (e.g. anti-CD4, anti-CD52 (Campath-1H) · Mitoxantrone,cyclophosphamide, Azathioprine, IVIG, cyclosporine A.
6 months before screening visit · Any investigational drug 21 days before screening visit · Systemic corticosteroids· ACTH Screening visit through Study Day 1 · Investigational drugs· Systemic corticosteroids· ACTH
United States, New Jersey | |
New Jersey Medical School | |
Newark, New Jersey, United States, 07103 |
Principal Investigator: | Diego Cadavid, MD | MD |
Study ID Numbers: | M167-2002 |
Study First Received: | September 13, 2005 |
Last Updated: | October 5, 2005 |
ClinicalTrials.gov Identifier: | NCT00176592 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Brain Betaserone Copaxone MRI |
Copolymer 1 Autoimmune Diseases Multiple Sclerosis Immunologic Factors Demyelinating Diseases Adjuvants, Immunologic |
Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Sclerosis Immunosuppressive Agents Autoimmune Diseases of the Nervous System |
Autoimmune Diseases Demyelinating Diseases Immune System Diseases Immunologic Factors Nervous System Diseases Physiological Effects of Drugs Adjuvants, Immunologic Sclerosis |
Immunosuppressive Agents Pharmacologic Actions Copolymer 1 Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |