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VX-702

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Vertex Pharmaceuticals Incorporated|Last Updated: Dec 7, 2007

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00395577A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702PHASE2 COMPLETED 120Nov 1, 2006Jul 1, 2007Dec 7, 200717 Bulgaria, Croatia +4
NCT00205478Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702PHASE2 COMPLETED 300Jun 1, 2005Feb 1, 2006Dec 7, 200743 Bulgaria, Croatia +7
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Study Endpoints
Primary Endpoints
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
The primary endpoint for the study is the ACR20 response at Week 12.
Secondary Endpoints
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
VX-702DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Adult patients 18 to 75 years of age with active RA * Must have been taking MTX for at least 6 months * No concurrent DMARD treatment (other than a stable dose of MTX) Exclusion Criteria: * Planned major surgery (e.g., joint replacement) within the duration of the treatment ...

Countries:BulgariaCroatiaPolandRussiaSerbia and MontenegroSloveniaCzechiaSlovakiaUkraine
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