Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects

NCT ID: NCT01624714

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alemtuzumab Naive

Alemtuzumab Subjects (30) with prior treatment refractoriness and treatment experience EDSS 3.0-7.0 inclusive, without contraindications to alemtuzumab

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: DRUG

alemtuzumab 12 mg IV x 5 daily doses at baseline, alemtuzumab 12 mg IV x 3 daily doses at month 12

Alemtuzumab immunotherapy

Intervention Type: DRUG

Alemtuzumab 60 mg over 5 days for first annual cycle, then 36 mg over 3 days for subsequent annual cycle, and as needed cycles in subsequent years.

Alemtuzumab Experienced

Subjects with treatment refractory MS and prior alemtuzumab therapy (30)

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: DRUG

alemtuzumab 12 mg IV x 5 daily doses at baseline, alemtuzumab 12 mg IV x 3 daily doses at month 12

Alemtuzumab immunotherapy

Intervention Type: DRUG

Alemtuzumab 60 mg over 5 days for first annual cycle, then 36 mg over 3 days for subsequent annual cycle, and as needed cycles in subsequent years.

Interventions

Alemtuzumab

alemtuzumab 12 mg IV x 5 daily doses at baseline, alemtuzumab 12 mg IV x 3 daily doses at month 12

Intervention Type: DRUG

Alemtuzumab immunotherapy

Alemtuzumab 60 mg over 5 days for first annual cycle, then 36 mg over 3 days for subsequent annual cycle, and as needed cycles in subsequent years.

Intervention Type: DRUG

Other Intervention Names

Campath; Lemtrada

Eligibility Criteria

Inclusion Criteria

• This trial treats subjects with relapsing variants of MS, including relapsing-remitting, progressive-relapsing, transitional, or secondary progressive MS, not amenable to other aggressive therapy, prior relapses, EDSS 2.5-7.0 inclusive. Most will have generally moderate to severe disability at EDSS >3 (EDSS 2.5-3 if significant cognitive complaints or MRI activity). Alemtuzumab experienced subjects at any EDSS level previously treated with alemtuzumab outside of a clinical trial are also eligible.

• All clinic patients who have been treated with alemtuzumab with our clinic method will be offered participation in the study, and may leave the study if desired after collection of data. Subjects wishing to sign informed consent but who have moved out of the region and are unable to be seen personally may be interviewed by telephone and included in the database after signing informed consent.

Exclusion Criteria

• Subjects are excluded if they have purely slowly progressive or definite primary progressive MS (e.g. slowly progressive corticosteroid unresponsive myelopathy) with no documented recent relapses, advanced age (over 75 years), legal minor status, or a recognized contraindication to alemtuzumab (active infection, malignancy (other than considered surgical cures by oncologist or basal cell carcinoma), uncontrolled bleeding disorder, planned pregnancy in immediate future or unwillingness to use contraception, or if they are in another alemtuzumab clinical trial.
• Prior autoimmunity which is in remission or controlled will be considered at the investigator's discretion.
• Our clinic experience is that prior Grave's disease is not a contraindication to alemtuzumab therapy.
• We have not previously excluded patients from alemtuzumab on the basis of any humoral immune marker (e.g. anti-thyroid), and therefore do not plan to perform such testing in screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samuel Forrester Hunter, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Samuel Forrester Hunter, MD, PhD

President

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samuel F Hunter, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Neurosciences Institute (ANI)

Locations

Advanced Neurosciences Institute

Franklin, Tennessee, United States

Countries

United States

Other Identifiers

NPI-004

Identifier Type: -

Identifier Source: org_study_id