Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects
The purpose of this study is to treat prospectively documented clinic patients with treatment-refractory multiple sclerosis that are naïve to alemtuzumab. Alemtuzumab shows efficacy and rate of serious adverse events (SAEs) which is equivalent or better than standard of care treatment strategies used previously for treatment-refractory multiple sclerosis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple Sclerosis|
- Change in Neurostatus Expanded Disability Status Scale [ Time Frame: Baseline and every 6 months over 5 years ] [ Designated as safety issue: Yes ]
- Change in MS Severity Scale [ Time Frame: Baseline and every 6 months for 5 years ] [ Designated as safety issue: Yes ]
- Change in annualized relapse rate [ Time Frame: Every 6 months during study ] [ Designated as safety issue: Yes ]
- Number of treatment days with high dose corticosteroids [ Time Frame: Every 6 months during study ] [ Designated as safety issue: Yes ]
- Rate of serious adverse events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- MRI-based cerebral volumes and burden of disease (in selected subjects) [ Time Frame: Baseline and yearly X 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Hypothesis Alemtuzumab manifests efficacy (e.g. improved MS Severity score, and treatment stability in relapse rate and Expanded Disability Status Scale [EDSS] progression) and serious adverse events (SAEs) equivalent or better than standard of care treatment strategies used prior to treatment for treatment-refractory multiple sclerosis.
Objectives Treat prospectively documented clinic patients treatment-refractory multiple sclerosis that are naïve to alemtuzumab.
Obtain retrospective disability, relapse, and adverse events in alemtuzumab-experienced subjects previously treated outside of clinical trial settings for treatment-refractory MS.
Obtain prospective safety and efficacy data for multiple sclerosis symptoms, disability, and adverse effects following the use of alemtuzumab for treatment-refractory MS in a population with exposures to prior cytotoxic and monoclonal antibody therapy.
Transition alemtuzumab-experienced clinic patients into a clinical trial setting for additional treatment with alemtuzumab as needed for refractory MS.
Coprimary outcomes will be: change in EDSS and converted EDSS to MS Severity scale.
Secondary outcomes: changes in annualized relapse rate, days of high dose corticosteroids, MRI-based cerebral volumes and burden of disease (in selected subjects), serious adverse events, and corticosteroid use. A questionnaire will be used to assess patient satisfaction with alemtuzumab as compared to prior therapies.
Safety outcomes will be assessed and tabulated.
|Contact: Samuel F Hunter, MD||(615) 791-5470|
|United States, Tennessee|
|Advanced Neurosciences Institute||Not yet recruiting|
|Franklin, Tennessee, United States, 37064|
|Contact: Samuel F Hunter, MD 615-791-5470|
|Principal Investigator: Samuel F Hunter, MD|
|Principal Investigator:||Samuel F Hunter, MD||Advanced Neurosciences Institute (ANI)|