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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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24 May 2021 |
Main ID: |
NCT02792231 |
Date of registration:
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02/06/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
ASCLEPIOS II |
Scientific title:
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A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis. |
Date of first enrolment:
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August 26, 2016 |
Target sample size:
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957 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02792231 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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Croatia
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Czechia
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Finland
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France
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Germany
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Hungary
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India
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Italy
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Latvia
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Lithuania
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Mexico
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Norway
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Peru
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Poland
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Portugal
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Russian Federation
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Slovakia
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South Africa
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Spain
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Switzerland
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Taiwan
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 to 55 years of age
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)
- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2
years or a positive gadolinium-enhancing MRI scan in previous year
- Expanded disability status scale (EDSS) score of 0 to 5.5
Exclusion Criteria:
- Primary progressive MS
- Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with
PML
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Multiple Scelrosis
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Intervention(s)
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Drug: Matching placebo of ofatumumab subcutaneous injections
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Drug: Teriflunomide-matching placebo capsules
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Drug: Teriflunomide capsule
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Drug: Ofatumumab subcutaneous injection
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Primary Outcome(s)
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Annualized Relapse Rate (ARR) (Confirmed Relapses)
[Time Frame: Baseline up to 2.5 years]
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Secondary Outcome(s)
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Number of Gd-enhancing T1 Lesions Per MRI Scan
[Time Frame: Baseline, yearly up to 2.5 years]
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6-month Confirmed Disability Improvement) (6mCDI ) Based on EDSS
[Time Frame: Baseline, every 3 months up to 2.5 years]
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Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline
[Time Frame: Baseline, months 12 and 24]
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Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate)
[Time Frame: Baseline, yearly up to 2.5 years]
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Neurofilament Light Chain (NfL) Concentration in Serum
[Time Frame: Month 3, 12, 24]
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3-month Confirmed Disability Worsening) (3mCDW) Based on EDSS
[Time Frame: Baseline, every 3 months up to 2.5 years]
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6-month Confirmed Disability Worsening (6mCDW) Based on EDSS
[Time Frame: Baseline, every 3 months up to 2.5 years]
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Secondary ID(s)
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COMB157G2302
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2015-005419-33
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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