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

NCT01624714 | Unknown Phase 1

• 1 other identifier: NPI-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Treatment Refractory

Outcome Measures

Primary Outcomes (2)

• Change in Neurostatus Expanded Disability Status Scale

  Baseline and every 6 months over 5 years

• Change in MS Severity Scale

  Baseline and every 6 months for 5 years

Secondary Outcomes (4)

• Change in annualized relapse rate

  Every 6 months during study

• Number of treatment days with high dose corticosteroids

  Every 6 months during study

• Rate of serious adverse events

  Duration of study

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

  Baseline and yearly X 5 years

Study Arms (2)

Alemtuzumab Naive

EXPERIMENTAL

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

Drug: Alemtuzumab; Drug: Alemtuzumab immunotherapy

Alemtuzumab Experienced

EXPERIMENTAL

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

Drug: Alemtuzumab; Drug: Alemtuzumab immunotherapy

Interventions

Alemtuzumab DRUG

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

Also known as: Campath, Lemtrada

Alemtuzumab Experienced; Alemtuzumab Naive

Alemtuzumab immunotherapy 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; Alemtuzumab Naive

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Forrester Hunter, MD, PhD: lead

Study Sites (1)

Advanced Neurosciences Institute

Franklin, Tennessee, 37064, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Samuel F Hunter, MD

  Advanced Neurosciences Institute (ANI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 21, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

US (1)