Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis

NCT01395316 | Completed Phase 4 Results DMC

• 1 other identifier: 10-490B
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Diffusion and Myelin Fraction Water Changes on Magnetic Resonance Imaging (MRI)

  Changes in normal appearing white matter from baseline through month 24. The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.

  Baseline to Month 24

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

Single arm, single cohort study, all subjects will be dosed with alemtuzumab.

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.

Also known as: CamPath, MabPath

Alemtuzumab

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed, informed consent form (ICF)
• Age 18 to 50 years old (inclusive) as of signing the ICF
• Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening
• Onset of MS symptoms (as determined by a neurologist) within 15 years of screening
• EDSS score 0.0 to 5.0 (inclusive)
• \>=2 MS attacks (first episode or relapse) occurring in the 24 months prior to screening, with \>=1 attack in the 12 months prior to screening, with objective neurological signs confirmed by a physician
• Subjects previously enrolled and randomized to interferon beta 1a in the CARE-MS 323 and 324 studies, and who will be treated with Alemtuzumab through the CARE-MS extension study will be eligible to participate in the immunology and MRI studies of this protocol.

You may not qualify if:

• Received prior therapy for MS other than corticosteroids within 28 days of screening; e.g., interferons, IV immunoglobulin, and glatiramer acetate
• Exposure to natalizumab within 6 months of screening
• Any prior exposure to mitoxantrone, mycophenolate mofetil, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, rituximab, or any other immunosuppressive agent other than systemic corticosteroid treatment
• Has any progressive form of MS
• History of malignancy (exception for basal cell skin carcinoma)
• Previous hypersensitivity reaction to other immunoglobulin product
• Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
• CD4+, CD8+, or CD19+ (i.e., absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3) count \<LLN at Screening; if abnormal cell count(s) return to within normal limits, eligibility may be reassessed
• Seropositivity for human immunodeficiency virus (HIV)
• Significant autoimmune disease (e.g, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders; vasculitis; inflammatory bowel disease; severe psoriasis)
• Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies
• Active infection, e.g, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
• Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis. Patients will be assessed for this risk based on a screening questionnaire.
• Infection with hepatitis B virus or hepatitis C virus
• Of childbearing potential with a positive serum pregnancy test

Sponsors & Collaborators

• University of Chicago: lead
• Genzyme, a Sanofi Company: collaborator

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

Results Point of Contact

• Title: Dr. Adil Javed
• Organization: University of Chicago

ajaved@neurology.bsd.uchicago.edu

Study Officials

• Adil Javed, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: July 1, 2017
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-11