Comparison of Alemtuzumab and Rebif (registered trademark) Efficacy in Multiple Sclerosis, Study One

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2008
INTERVENTION: alemtuzumab; 12 mg per day administered through intravenous therapy (IV), once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive days at Month 12 CONDITION: Multiple Sclerosis, Relapsing‐Remitting PRIMARY OUTCOME: Relapse Rate based on patient report with physician confirmation of objective neurologic changes Time to Sustained Accumulation of Disability (SAD) based on increases in scores on the Expanded Disability Status Scale (EDSS) lasting at least 6 months SECONDARY OUTCOME: Acquisition of disability as measured by change from baseline in Multiple Sclerosis Functional Composite (MSFC) Change from baseline in EDSS Percent change from baseline in magnetic resonance imaging (MRI) T2‐weighted hyperintense lesion volume at Year 2 Proportion of patients who are relapse free at Year 2 Safety, based on adverse event reporting and laboratory testing. These are safety provisions outlined in the protocol and not secondary outcomes. INCLUSION CRITERIA: 1. Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years 2. Onset of MS symptoms within 5 years 3. EDSS score 0.0 to 3.0 4. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months
Epistemonikos ID: 559c74b8073a83484ee45a0c77857759e6f17712
First added on: Aug 21, 2024