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natalizumab treatment

Phase 1

Relapsing Forms of Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Sep 4, 2009

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
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00424788A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)EARLY_PHASE1 COMPLETED 12Jan 1, 2007Oct 1, 2007Sep 4, 20092 United States
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Plasma exchangePROCEDURE -
natalizumab treatmentDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * considered by the Investigator to be free of signs and symptoms suggestive of any serious opportunistic infection * willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta and glatiramer acetate) for th...

Countries:United States
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