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JNJ-40346527

Phase 2

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Johnson & Johnson|Last Updated: Apr 8, 2014

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01597739A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug TherapyPHASE2 COMPLETED 96Jul 1, 2012Apr 1, 2013Apr 8, 201432 Argentina, Bulgaria +8
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Study Endpoints
Primary Endpoints
Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP)
Week 12

The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.

Secondary Endpoints
ACR 20 response
Week 12
DAS28 (using CRP) response
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-40346527EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
JNJ-40346527DRUGType=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
PlaceboDRUGForm=capsule; route=oral use; twice daily.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) for at least 6 months prior to screening * Have been positive for, or are positive at screening for, either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum * Have active RA with at least 6 swollen ...

Countries:ArgentinaBulgariaChileCzechiaHungaryPolandRussiaSingaporeSouth KoreaUkraine
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