Recent Updates
Recently added Catalysts

PD 0360324

Phase 1

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: Jul 14, 2009

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00550355Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid ArthritisPHASE1 COMPLETED 78Aug 1, 2007Jun 1, 2009Jul 14, 200925 United States, Argentina +6
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Clinical safety laboratories
16 weeks
Vital signs
16 weeks
ECG
16 weeks
Incidence and severity of adverse events
16 weeks
Secondary Endpoints
Pharmacokinetic
16 weeks
Pharmacodynamic
16 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PD 0360324DRUG3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
PlaceboDRUG3 doses of Placebo administered over 12 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of RA for at least 6 months based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. * Must have been treated with methotrexate (≥7.5 mg/week to ≤25 mg/week) for at least 16 weeks immediately prior to enrollment. The dose of methotrexate must be s...

Countries:United StatesArgentinaBulgariaCzechiaMexicoPolandSlovakiaSpain
Unlock Eligibility Criteria