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MK0812 / Duration of Treatment: 12 Weeks

Phase 2

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Merck & Company, Inc.|Last Updated: Oct 20, 2015

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment149
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00542022Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)PHASE2 COMPLETED 149Jun 1, 2004May 1, 2005Oct 20, 2015 -
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Study Endpoints
Primary Endpoints
MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count
12 weeks
Secondary Endpoints
MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MK0812 / Duration of Treatment: 12 WeeksDRUG -
Comparator: placebo (unspecified) / Duration of Treatment: 12 WeeksDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed * Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints * Excepting rhe...

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