| A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
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| A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
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| 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.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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| Psoriatic Arthritis
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- 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.
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- Experimental: PF-06700841 60 mg once daily
PF-06700841 60 mg once daily for 52 weeks
Intervention: Drug: PF-06700841
- Experimental: PF-06700841 30 mg once daily
PF-06700841 30 mg once daily for 52 weeks
Intervention: Drug: PF-06700841
- Experimental: PF-06700841 10 mg once daily followed by 60 mg once daily
PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52
Intervention: Drug: PF-06700841
- Experimental: PF-06700841 10 mg once daily followed by 30 mg once daily
PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52
Intervention: Drug: PF-06700841
- Placebo Comparator: Placebo once daily followed by 60 mg once daily
Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52
Intervention: Other: Placebo
- Placebo Comparator: Placebo once daily followed by 30 mg once daily
Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
Intervention: Other: Placebo
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Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
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| Recruiting
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| 196
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Same as current
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| January 12, 2021
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| April 6, 2020 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
- Active plaque psoriasis at screening and baseline.
Exclusion Criteria:
- Non-plaque forms of psoriasis (with exception of nail psoriasis).
- History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA.
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| Sexes Eligible for Study: |
All |
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| 18 Years to 75 Years (Adult, Older Adult)
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| No
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| Australia, Belarus, Bulgaria, Czechia, Estonia, Hungary, Lithuania, Poland, Russian Federation, Serbia, Slovakia, Spain
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| NCT03963401
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B7931030
2018-004241-16 ( EudraCT Number )
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| Yes
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| Studies a U.S. FDA-regulated Drug Product: |
No |
| Studies a U.S. FDA-regulated Device Product: |
No |
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| February 2020
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