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Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis (OPTIMUM)

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ClinicalTrials.gov Identifier: NCT02425644
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Description
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Brief Summary:
International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: ponesimod Drug: teriflunomide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 4, 2015
Estimated Primary Completion Date : April 17, 2019
Estimated Study Completion Date : May 15, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ponesimod
20 mg administered orally once daily in the morning
 Drug: ponesimod
20 mg
Other Name: ACT-128800
Active Comparator: teriflunomide
14 mg administered orally once daily in the morning
 Drug: teriflunomide
14 mg


Outcome Measures
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Primary Outcome Measures :
  1. Annualized relapse rate (ARR) [ Time Frame: baseline to end of treatment (week 108) ]
    defined as the number of confirmed relapses per subject-year


Secondary Outcome Measures :
  1. Time to 12-week confirmed disability accumulation (CDA) [ Time Frame: baseline to end of treatment (week 108) ]
  2. Percent change in brain volume (PCBV) [ Time Frame: baseline to end of treatment (week 108) ]
  3. Time to first confirmed relapse [ Time Frame: baseline to end of treatment (week 108) ]
  4. Cumulative number of combined unique active lesions [ Time Frame: baseline to end of treatment (week 108) ]
    (CUAL; defined as new Gd+ T1 lesions plus new or enlarging T2 lesions [without double-counting of lesions])

  5. Change from baseline to Week 108 in fatigue-related symptoms [ Time Frame: baseline to end of treatment (week 108) ]
    measured by the symptoms domain of the Fatigue Symptoms and Impact Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 randomization, or by two or more MS attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

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.

Exclusion Criteria:

Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425644


  Show 162 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Ewa Lindenstrøm, MD, PhD Actelion
More Information
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02425644     History of Changes
Other Study ID Numbers: AC-058B301
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Actelion:
relapsing multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases