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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 December 2021 |
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Main ID: |
NCT03737812 |
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Date of registration:
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06/11/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis |
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Date of first enrolment:
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February 27, 2019 |
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Target sample size:
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123 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03737812 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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ABBVIE INC. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing
secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24
months.
- Evidence of physical disability according to Expanded Disability Status Scale (EDSS)
or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.
Exclusion Criteria:
- Treatment with any of the following within the 6 months prior to Screening:
natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil;
intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral,
or intrathecal corticosteroids for the purposes of disease modification.
- Treatment with the following within 1 year prior to Screening: cyclophosphamide or
alemtuzumab.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis (MS)
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Intervention(s)
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Drug: placebo
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Drug: elezanumab
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Primary Outcome(s)
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Mean Overall Response Score (ORS)
[Time Frame: Week 52]
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Secondary Outcome(s)
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Disability Improvement Response Rate
[Time Frame: Week 52]
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Overall Response Score (ORS)
[Time Frame: Up to Week 36]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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