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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8 March 2021 |
Main ID: |
NCT04032158 |
Date of registration:
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23/07/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
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Scientific title:
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A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety |
Date of first enrolment:
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August 26, 2019 |
Target sample size:
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3 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT04032158 |
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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Austria
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Belgium
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Bosnia and Herzegovina
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Bulgaria
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Canada
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Croatia
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Czechia
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Estonia
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France
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Georgia
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Germany
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Hungary
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Israel
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Italy
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Korea, Republic of
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Mexico
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Montenegro
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Poland
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Russian Federation
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Serbia
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Spain
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Taiwan
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Ukraine
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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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Medical Responsible |
Address:
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Telephone:
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Email:
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Affiliation:
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria: - Participants are diagnosed with RMS (relapsing-remitting multiple
sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in
accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with one or
more documented relapses within the 2 years before Screening with either: a. one relapse
which occurred within the last year prior to randomization, OR b. the presence of at least
1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization -
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Baseline.
Participants with an EDSS score <= 2 at Screening are only eligible for participation if
their disease duration (time since onset of symptoms) is no more than 10 years -
Participants are neurologically stable for >= 30 days prior to both screening and baseline
- Female participants must be neither pregnant nor breast-feeding and must lack
child-bearing potential, as defined by either: post-menopausal or surgically sterile or use
an effective method of contraception for the duration of the study - Participants have
given written informed consent prior to any study-related procedure - Other protocol
defined inclusion criteria could apply Exclusion Criteria: - Participants diagnosed with
Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a).
Participants with Primary Progressive MS. b). Participants with secondary progressive MS
without evidence of relapse.
- Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at
screening.
- Immunologic disorder other than MS, or any other condition requiring oral, intravenous
(IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of
well-controlled Type 2 diabetes mellitus or well controlled thyroid disease.
- Other protocol defined exclusion criteria could apply.
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-remitting Multiple Sclerosis
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Intervention(s)
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Drug: Avonex®
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Drug: Placebo
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Drug: Evobrutinib
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Primary Outcome(s)
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Annualized Relapse Rate (ARR)
[Time Frame: At Week 96]
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Secondary Outcome(s)
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Absolute Concentrations of Immunoglobulin (Ig) Levels
[Time Frame: Baseline up to Week 100]
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Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)
[Time Frame: Baseline up to Week 100]
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Total Number of New or Enlarging T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans
[Time Frame: At Weeks 24, 48, and 96]
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Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score
[Time Frame: Baseline, Week 96]
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Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score
[Time Frame: Baseline, Week 96]
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Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans
[Time Frame: At Weeks 24, 48, and 96]
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Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
[Time Frame: Baseline up to 96 weeks]
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Change From Baseline in Immunoglobulin (Ig) Levels
[Time Frame: Baseline up to Week 100]
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Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
[Time Frame: Baseline up to 96 weeks]
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
[Time Frame: Baseline up to Week 100]
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Secondary ID(s)
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MS200527_0073
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2018-004701-11
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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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