CompletedPhase 4

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

8 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: Baseline to Month 24

Trial details

NCT IDNCT01395316

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

Results submitted2018-11-13

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