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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