Recent Updates
Recently added Catalysts

leflunomide

Phase 3

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Sanofi|Last Updated: Oct 13, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00596206Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid ArthritisPHASE3 COMPLETED 124 — — Dec 1, 2007Oct 1, 2009Oct 13, 20105 Czechia, Italy +3
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Clinical efficacy response rate using ACR 20 criteria in each initial dosing regimen group
at 3 month
Secondary Endpoints
Clinical efficacy response rate using ACR 50, ACR 70, DAS 28 efficacy criteria in each group of treatment
at 1 and 3 months
Clinical and biological safety using standard blood monitoring, TEAED and SAE in each group of treatment
From the Informed Consent Form (ICF) signature to the end of the study
Measure of acute phase response (ESR, CRP)
At 1 and 3 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL100 mg of leflunomide
2ACTIVE_COMPARATOR20 mg of leflunomide
Interventions
NameTypeDescription
leflunomideDRUG20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines) * Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs) Exclusion Criteria: * Patient presenting or having a history of other inflammator...

Countries:CzechiaItalyPortugalRomaniaSouth Korea
Unlock Eligibility Criteria