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Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients

Phase 3
18 Years
50 Years
Open (Enrolling by invite only)
Relapsing Remitting Multiple Sclerosis

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Trial Information

Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients

Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous
System (CNS). There are many forms of MS; although the majority are Relapsing Remitting
(RRMS) representing approximately 80% of the cases. The disease appears to be more
inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and
an increase in inflammatory bio-assay markers.

Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and
B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and
sustained lymphocyte depletion and is approved for the treatment of B-cell chronic
lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.

There are two parts to this Investigator Sponsored Trial (IST):

1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.

2. To provide serum samples for the University of Southern California (USC) ICAM125
lymphocyte recovery study.

Inclusion Criteria:

- Signed, informed consent form

- Age 18 to 50 years old (inclusive)

- 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 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.

Exclusion Criteria:

- Received prior therapy for MS other than corticosteroids within 28 days of screening;
e.g., interferon's, 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 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

- Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or
active tuberculosis.

- Infection with hepatitis B virus or hepatitis C virus

- Of childbearing potential with a positive serum pregnancy test

- Unwilling to agree to use a reliable and acceptable contraceptive method throughout
the study period

- Major psychiatric disorder that is not adequately controlled by treatment

- Epileptic seizures that are not adequately controlled by treatment

- Major systemic disease or other illness that would, in the opinion of the
Investigator, compromise patient safety or interfere with the interpretation of study

- Medical, psychiatric, cognitive, or other conditions

- Confirmed platelet count the lower limit of normal (LLN) of the evaluating laboratory
at Screening or documented at 100,000/L within the past year on a sample without

- Prior history of invasive fungal infections

- Cervical high risk human papilloma virus (HPV) positivity or abnormal cervical
cytology other than abnormal squamous cells of undetermined significance (ASCUS).

- Seropositive for Trypanosoma cruzi or the Human T-lymphotropic virus type I or type
II (HTLV-I/II) (testing required in endemic regions only)

- Any other illness or infection (latent or active) that, in the Investigator's
opinion, could be exacerbated by alemtuzumab treatment

- Any hepatic or renal function value grade 2 or higher at Screening, with the
exception of hyperbilirubinemia due to Gilbert's syndrome.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in normal appearing white matter from baseline through month 24.

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Anthony Traboulsee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of British Columbia


Canada: Health Canada

Study ID:




Start Date:

March 2011

Completion Date:

February 2018

Related Keywords:

  • Relapsing Remitting Multiple Sclerosis
  • Multiple Sclerosis
  • MS
  • Relapsing Remitting Multiple Sclerosis
  • RRMS
  • Alemtuzumab
  • Demyelination
  • Remyelination
  • Tolerogenic
  • T cells
  • Demyelinating Autoimmune Diseases, CNS
  • Autoimmune Diseases of the Nervous System
  • Nervous System Diseases
  • Demyelinating Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting