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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.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT03737812
Date of registration: 06/11/2018
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Scientific title: 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
Date of first enrolment: February 27, 2019
Target sample size: 123
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03737812
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     AbbVie Inc.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Multiple Sclerosis (MS)
Intervention(s)
Drug: elezanumab
Drug: placebo
Primary Outcome(s)
Mean Overall Response Score (ORS) [Time Frame: Week 52]
Secondary Outcome(s)
Disability Improvement Response Rate [Time Frame: Week 52]
Overall Response Score (ORS) [Time Frame: Up to Week 36]
Secondary ID(s)
M14-397
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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