Advanced MRI Measures of Repair in Alemtuzumab Treated Patients (NCT01307332) | Clinical Trial Compass
CompletedPhase 3
Advanced MRI Measures of Repair in Alemtuzumab Treated Patients
Canada27 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) count \<LLN at Screening; if abnormal cell count(s) return to within normal limits, eligibility may be reassessed
* Seropositivity for human immunodeficiency virus (HIV)
* Si…
What they're measuring
1
Changes in normal appearing white matter from baseline through month 24.