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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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2012-000540-10-FI |
Date of registration:
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19/08/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis
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Scientific title:
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Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM |
Date of first enrolment:
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23/09/2015 |
Target sample size:
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1100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000540-10 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Belarus
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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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Czech Republic
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Finland
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France
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Georgia
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Germany
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Greece
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Hungary
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Israel
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Italy
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Latvia
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Lithuania
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Mexico
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Spain
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Sweden
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Turkey
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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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Clinical Trial Disclosure Desk
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Address:
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Gewerbestrasse 16
4123
Allschwil
Switzerland |
Telephone:
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Email:
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clinical-trials-disclosure@its.jnj.com |
Affiliation:
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Actelion Pharmaceuticals Ltd |
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Name:
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Clinical Trial Disclosure Desk
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Address:
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Gewerbestrasse 16
4123
Allschwil
Switzerland |
Telephone:
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Email:
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clinical-trials-disclosure@its.jnj.com |
Affiliation:
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Actelion Pharmaceuticals Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses). Subjects must have active disease evidenced by one or more MS attacks with onset within the period of 12 to 1 months prior to baseline EDSS assessment, or by two or more MS attacks with onset within the 24 to 1 months prior to baseline EDSS assessment, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to baseline EDSS assessment. Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, ocular) or lactating or pregnant women are not eligible to enter the study. Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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relapsing multiple sclerosis
MedDRA version: 20.0
Level: PT
Classification code 10063400
Term: Secondary progressive multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0
Level: PT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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Product Name: Ponesimod Product Code: ACT-128800 Pharmaceutical Form: Capsule INN or Proposed INN: Ponesimod Current Sponsor code: ACT-128800 Other descriptive name: PONESIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product Name: Ponesimod Product Code: ACT-128800 Pharmaceutical Form: Tablet INN or Proposed INN: Ponesimod CAS Number: ACT-128800 Other descriptive name: PONESIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Trade Name: Aubagio® Product Name: Aubagio® Pharmaceutical Form: Tablet INN or Proposed INN: TERIFLUNOMIDE CAS Number: 108605-62-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 14- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Product Name: Ponesimod Product Code: ACT-128800 Pharmaceutical Form: Tablet INN or Proposed INN: Ponesimod CAS Number: ACT-128800 Other descriptive name: PONESIMOD Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: Ponesimod Product Code: ACT-1
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Primary Outcome(s)
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Main Objective: - To determine whether ponesimod is more efficacious than teriflunomide in terms of reducing relapses in subjects with RMS.
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Secondary Objective: - To assess the effect of ponesimod on disability accumulation and on other aspects of multiple sclerosis (MS) disease control - To assess the safety and tolerability of ponesimod in subjects with RMS.
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Timepoint(s) of evaluation of this end point: All relapses up to EOS will be included in the analysis, irrespective of any treatment discontinuations prior to study completion.
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Primary end point(s): Annualized relapse rate defined as the number of confirmed relapses per subject-year.
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Secondary Outcome(s)
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Secondary end point(s): 1. Change from baseline to Week 108 in fatigue-related symptoms as measured by the symptoms domain of the Fatigue Symptoms and Impact Questionnaire – Relapsing Multiple Sclerosis (FSIQ–RMS); 2. Cumulative number of combined unique active lesions (CUAL; defined as new Gd+ T1 lesions plus new or enlarging T2 lesions [without doublecounting of lesions]) from baseline to Week 108; 3. Time to 12-week confirmed disability accumulation (CDA) from baseline to EOS; 4. Time to 24-week CDA from baseline to EOS.
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Timepoint(s) of evaluation of this end point: 1: end of study 2, 4, 5: week 108 3: time to first confirmed relapse
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Secondary ID(s)
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2012-000540-10-DE
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AC-058B301
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Source(s) of Monetary Support
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Actelion Pharmaceuticals Ltd
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Ethics review
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Status: Approved
Approval date:
Contact:
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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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