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MTX

Phase 3

Psoriasis | Small molecule | Immunology |Abbott Laboratories|Last Updated: Jul 17, 2008

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment271
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00235820Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 271Jul 1, 2005 -Jul 17, 20081 United States
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Study Endpoints
Primary Endpoints
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Week 16
Safety parameters
Every Study Visit
Secondary Endpoints
Physician Global Assessment
Baseline - Week 16
PASI 50/90/100
Baseline - Week 16
DLQI
Baseline - Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
adalimumabDRUG40 mg every other week following an 80 mg dose
MTXDRUGMTX 7.5 to 25 mg once weekly
placebo adalimumab, placebo MTXDRUGplacebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis * Subject is a candidate for systemic therapy or pho...

Countries:United States
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