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
Recruitment status was Active, not recruiting
This is the first comparison of efficacy of Betaseron and Copaxone for treatment of relapsing forms of MS.
Drug: Betaserone or Copaxone, MRI and Gadolinum
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The primary outcome measure is the number of "combined active" lesions by monthly MRI at the conclusion of the study.
- The number of enhancing lesions.
- The number of new lesions on long TR.
- The number of "combined active" disease free patients.
|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 "combined-active" lesions by monthly MRI at the conclusion of the study, which includes contrast enhancing lesions and non-enhancing lesions on long TR scans that have appeared since the most recent examination. Several secondary MRI outcome measures are studied in addition to the number of enhancing lesions and the number of new lesions on long TR images. We will examine the number of patients who remain "combined-active disease-free" for the duration of the study and the number of "combined-active disease-free" scans. Apart from these traditional methods of analysis by a reader who will be blinded to patient clinical status and therapy, objective volumetric analysis will be carried out. Making use of both automated and manual techniques, we will determine the overall burden of disease (the volume of lesions on long TR scans), the burden of active disease (the volume of brain enhancement) and the burden of chronic disease (the volume of lesions that are markedly hypointense on T1). 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).
|United States, New Jersey|
|New Jersey Medical School|
|Newark, New Jersey, United States, 07103|
|Principal Investigator:||Diego Cadavid, MD||MD|