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PF-04171327

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Sep 4, 2024

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 Trials2
Total Enrollment409
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01393639Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid ArthritisPHASE2 COMPLETED 323Sep 27, 2011Jun 9, 2014Sep 4, 202493 United States, Bulgaria +16
NCT00938587A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid ArthritisPHASE2 COMPLETED 86Oct 7, 2009Jul 29, 2010Nov 22, 202341 United States, Czechia +11
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
Week 8

ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
Week 8

Change from baseline in P1NP at week 8 is presented in this outcome measure.

Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
Week 8

Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14
Baseline, Day 14

DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (\<) 10 milligram per liter \[mg/L\], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 \[very well condition\] to 100 \[very poor condition\], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (\<=) 3.2 implied low disease activity; greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.

Secondary Endpoints
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, and 12 (taper period)
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, 6, 8, and 12 (taper period)
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
Weeks 2, 4, 6, 8, and 12 (taper period)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-04171327 1 mg QDEXPERIMENTAL -
PF-04171327 5 mg QDEXPERIMENTAL -
PF-04171327 10 mg QDEXPERIMENTAL -
PF-04171327 15 mg QDEXPERIMENTAL -
prednisone 5 mg QDACTIVE_COMPARATOR -
prednisone 10 mg QDACTIVE_COMPARATOR -
placeboPLACEBO_COMPARATOR -
PF-04171327 10 mgEXPERIMENTAL -
PF-04171327 25 mgEXPERIMENTAL -
PrednisoneACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PF-04171327DRUG1 mg tablet once daily (QD) for 8 weeks
prednisoneDRUG5 mg capsule once daily for 8 weeks
placeboOTHERplacebo (tablet or capsule) once daily (QD) for 8 weeks
PF-04171327 10 mgDRUGPF-04171327 10 mg tablet every day for 14 days
Prednisone PlaceboOTHERPlacebo for Prednisone 5 mg tablet every day for 14 days
PF-04171327 25 mgDRUGPF-04171327 25 mg tablet every day for 14 days
Prednisone 5 mgDRUGPrednisone 5 mg tablet every day for 14 days
Placebo for PF-04171327OTHERPlacebo for PF-04171327 every day for 14 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites93

Inclusion Criteria: * Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of an...

Countries:United StatesBulgariaColombiaCzechiaGermanyHungaryIndiaMalaysiaMexicoPolandRomaniaRussiaSerbiaSlovakiaSouth AfricaSouth KoreaSpainUkraineHong KongSingaporeTaiwanTurkey (Türkiye)
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