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

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alemtuzumab

Alemtuzumab immunotherapy

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Treatment Refractory

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Inclusion Criteria for Alemtuzumab Experienced Subjects:

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.

Sites / Locations

Advanced Neurosciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Alemtuzumab Naive

Alemtuzumab Experienced

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Neurostatus Expanded Disability Status Scale

Change in MS Severity Scale

Secondary Outcome Measures

Change in annualized relapse rate

Number of treatment days with high dose corticosteroids

Rate of serious adverse events

MRI-based cerebral volumes and burden of disease (in selected subjects)

Full Information

NCT ID

NCT01624714

First Posted

June 18, 2012

Last Updated

March 8, 2014

Sponsor

Samuel Forrester Hunter, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT01624714

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Samuel Forrester Hunter, MD, PhD

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Treatment Refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alemtuzumab Naive

Arm Type

Experimental

Arm Description

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

Arm Title

Alemtuzumab Experienced

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab

Other Intervention Name(s)

Campath, Lemtrada

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab immunotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Neurostatus Expanded Disability Status Scale

Time Frame

Baseline and every 6 months over 5 years

Title

Change in MS Severity Scale

Time Frame

Baseline and every 6 months for 5 years

Secondary Outcome Measure Information:

Title

Change in annualized relapse rate

Time Frame

Every 6 months during study

Title

Number of treatment days with high dose corticosteroids

Time Frame

Every 6 months during study

Title

Rate of serious adverse events

Time Frame

Duration of study

Title

MRI-based cerebral volumes and burden of disease (in selected subjects)

Time Frame

Baseline and yearly X 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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. Inclusion Criteria for Alemtuzumab Experienced Subjects: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel F Hunter, MD

Organizational Affiliation

Advanced Neurosciences Institute (ANI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Advanced Neurosciences Institute

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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