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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
851 Broken Sound Parkway Northwest
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Phone: 561-939-0300
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2799 West Grand Boulevard
Detroit, Michigan 48202
Detroit, Michigan 48202
Phone: 313-916-7202
Click here to add this to my saved trials
Click here to add this to my saved trials
101 Forrest Crossing Boulevard
Franklin, Tennessee 37064
Franklin, Tennessee 37064
Phone: 615-791-5470
Click here to add this to my saved trials
Heidelberg, Victoria
Phone: +61 3 9496 5000
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
301 North Maitland Avenue
Maitland, Florida 32751
Maitland, Florida 32751
Phone: 407-647-5996
Click here to add this to my saved trials
240 East 38th Street
New York, New York 10016
New York, New York 10016
Phone: 646-501-7500
Click here to add this to my saved trials
5 East 98th Street
New York, New York 10029
New York, New York 10029
Phone: 212-241-6854
Click here to add this to my saved trials
535 Northwest 9th Street
Oklahoma City, Oklahoma 73102
Oklahoma City, Oklahoma 73102
Phone: 405-534-5349
Click here to add this to my saved trials
8 Mirror Lake Drive
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Phone: 386-676-6340
Click here to add this to my saved trials
Overland Park, Kansas 66213
Phone: 913-827-4202
Click here to add this to my saved trials
Click here to add this to my saved trials
900 Walnut Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Phone: 215-955-6871
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Torrance, California 90502
Phone: 310-222-3897
Click here to add this to my saved trials
Click here to add this to my saved trials