Advanced MRI Measures of Repair in Alemtuzumab Treated Patients

• Status: Completed
• Trial end date: 2018-09-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Alemtuzumab

Criteria

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

• Neurostatus (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) countScreening; 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 results

• 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 clumping

• 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.