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MK-0873

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Merck & Company, Inc.|Last Updated: Jul 30, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00132769A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)PHASE2 COMPLETED 106Jan 1, 2005Nov 1, 2005Jul 30, 2015 -
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Study Endpoints
Primary Endpoints
Change From Baseline in Swollen Joint Count
Baseline and the average of Treatment Weeks 8, 10 and 12

Swollen joint count (SJC) was determined by assessing 66 joints (33 right side, 33 left side) for swelling using the following grading system: 0=Absent, 1=Detectable synovial thickening without loss of bony contours, 2=Loss of distinctiveness of bony contours, or 3=Bulging synovial proliferation with cystic characteristics. The total number of joints graded 1, 2, or 3 were then counted to yield the SJC. SJC ranged from 1-66, with increasing score indicating greater number of swollen joints. SJC was averaged over weeks 8, 10 and 12 to yield a Treatment Period Mean. Change from Baseline = Treatment Period Mean SJC - Baseline SJC.

Secondary Endpoints
Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
Baseline and the average of Treatment Weeks 8, 10 and 12
Change From Baseline in Tender Joint Count
Baseline and the average of Treatment Weeks 8, 10 and 12
Patient Global Assessment of Disease Activity
The average of Treatment Weeks 8, 10 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-0873EXPERIMENTALMK-0873 1.25 mg twice daily for 12 weeks
PlaceboPLACEBO_COMPARATORMatching placebo to MK-0873 1.25 mg twice daily for 12 weeks
Interventions
NameTypeDescription
MK-0873DRUGMK-0873 1.25 mg twice daily for 12 weeks
Comparator: PlaceboDRUGMatching placebo to MK-0873 1.25 mg twice daily for 12 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications * Other criteria also apply Exclusion Criteria: * Other major illnesses * Past history of certain other disorders * Certain prohibited medication...

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