Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology, Multiple Sclerosis |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 3/22/2019 |
Start Date: | March 30, 2017 |
End Date: | March 31, 2020 |
Contact: | CTD Clinical Trial Disclosure Desk |
Email: | clinical-trials-disclosure@its.jnj.com |
Phone: | +41 (0)61 565 65 65 |
Multicenter, Randomized, Double-blind, Parallel-group, add-on, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)
This clinical study compares the efficacy, safety, and tolerability of therapy with ponesimod
vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
vs placebo in subjects with active RMS who are treated with DMF (Tecfidera®).
Inclusion Criteria:
- Signed informed consent prior to initiation of any study-mandated procedure.
- Women of childbearing potential must have a negative pregnancy test and use reliable
methods of contraception
- Presenting with a diagnosis of MS as defined by the revised (2010) McDonald Diagnostic
Criteria for MS with relapsing course from onset (i.e., relapsing-remitting multiple
sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) with superimposed
relapses).
- Ongoing treatment with DMF for at least 6 months prior to screening
- Active disease after at least 3 months of DMF treatment
- Ambulatory and with an EDSS score between 0 and 6.0 (inclusive).
Exclusion Criteria:
- Lactating or pregnant women and women intending to become pregnant during the study.
- Presenting with a diagnosis of MS with progressive course from onset (i.e., primary
progressive MS or progressive relapsing MS).
- Evidence of a relapse of MS with onset within 30 days prior to baseline EDSS
assessment.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol.
We found this trial at
30
sites
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Phone: 212-662-3647
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Phone: 303-724-2187
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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851 Broken Sound Parkway Northwest
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Phone: 561-939-0300
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2799 West Grand Boulevard
Detroit, Michigan 48202
Detroit, Michigan 48202
Phone: 313-916-7202
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101 Forrest Crossing Boulevard
Franklin, Tennessee 37064
Franklin, Tennessee 37064
Phone: 615-791-5470
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Heidelberg, Victoria
Phone: +61 3 9496 5000
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-588-6980
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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301 North Maitland Avenue
Maitland, Florida 32751
Maitland, Florida 32751
Phone: 407-647-5996
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240 East 38th Street
New York, New York 10016
New York, New York 10016
Phone: 646-501-7500
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5 East 98th Street
New York, New York 10029
New York, New York 10029
Phone: 212-241-6854
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535 Northwest 9th Street
Oklahoma City, Oklahoma 73102
Oklahoma City, Oklahoma 73102
Phone: 405-534-5349
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8 Mirror Lake Drive
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Phone: 386-676-6340
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Overland Park, Kansas 66213
Phone: 913-827-4202
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900 Walnut Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Phone: 215-955-6871
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Torrance, California 90502
Phone: 310-222-3897
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