A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis

NCT03963401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2021-08-04

Study results available
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Summary

This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.

Conditions

Interventions

DRUG

PF-06700841

Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.

OTHER

Placebo

Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2020-04-06
Completion
2021-01-15
FDA Drug
Yes

Countries

  • Australia
  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • Lithuania
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963401 on ClinicalTrials.gov