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R788

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Rigel Pharmaceuticals, Inc.|Last Updated: Apr 20, 2009

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 Enrollment189
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00326339Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)PHASE2 COMPLETED 189Aug 1, 2006Dec 1, 2007Apr 20, 200938 United States, Mexico
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Study Endpoints
Primary Endpoints
The Primary Efficacy parameter is ACR20 response rate at 3 months post dosing.
12 weeks
Secondary Endpoints
ACR 20/50 responses over time
12 weeks
Disease Activity Score (DAS) at baseline and endpoint
12 Weeks
Mean changes (SDs) from baseline in Swollen Joint Count (28 joint count)
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALR788 50 mg PO bid
2EXPERIMENTALR788 100 mg PO bid
3EXPERIMENTALR788 150 mg PO bid
4PLACEBO_COMPARATORPlacebo PO bid
Interventions
NameTypeDescription
R788DRUGR788 50 mg, 100 mg, or 150 mg PO bid
PlaceboDRUGPlacebo PO bid
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Patients must give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study. 2. Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) ...

Countries:United StatesMexico
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