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Rebif

Phase 3

Clinically Isolated Syndrome | Small molecule | Other |Merck & Company, Inc.|Last Updated: Dec 27, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00287079A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated SyndromePHASE3 COMPLETED 35Oct 1, 2005Nov 1, 2008Dec 27, 20131 Canada
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Study Endpoints
Primary Endpoints
Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
Up to Week 96

CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.

Secondary Endpoints
Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
Up to Week 96
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Up to Week 96
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Study Design & Arms
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rebif®EXPERIMENTAL -
No TreatmentOTHER -
Interventions
NameTypeDescription
Rebif®DRUG44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No TreatmentOTHERNo treatment for 96 weeks
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Eligibility Criteria
Age Range18 Months — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must have experienced a first clinical episode suggestive of demyelinating disease * Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS) * Subject must be greater than or equal to 18 years ...

Countries:Canada
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