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dose level 1

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Nov 2, 2018

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00838565Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid ArthritisPHASE1 COMPLETED 41May 20, 2009Feb 2, 2012Nov 2, 20188 United States, South Korea +1
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Positive Anti-drug Antibodies Response
Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Maximum Observed Serum Concentration (Cmax): Day 1
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Maximum Observed Serum Concentration (Cmax): Day 28
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Maximum Observed Serum Concentration (Cmax): Day 56
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose

AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).

Serum Decay Half-Life (t1/2): Day 56
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

Serum decay half-life is the time measured for the serum concentration to decrease by one half.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
PF-04236921EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUGintravenous infusion on three consecutive months
dose level 1DRUGintravenous infusion on three consecutive months
dose level 2DRUGintravenous infusion on three consecutive months
dose level 3DRUGintravenous infusion on three consecutive months
dose level 4DRUGintravenous infusion on 3 consecutive months
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Rheumatoid Arthritis on a stable dose of methotrexate * Rheumatoid Arthritis disease activity as assessed by blood tests Exclusion Criteria: * Serious or uncontrolled medical conditions * Current or recent treatment with disease-modifying drugs other than methotrexate includ...

Countries:United StatesSouth KoreaSpain
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