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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Other: Placebo; Drug: PF-06700841

Study type: Interventional

Funder types: Industry

Identifiers

NCT03963401

B7931030

2018-004241-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 6 patient groups, including a placebo group

PF-06700841 60 mg once daily

Experimental group

Description:

PF-06700841 60 mg once daily for 52 weeks

Treatment:

Drug: PF-06700841

PF-06700841 30 mg once daily

Experimental group

Description:

PF-06700841 30 mg once daily for 52 weeks

Treatment:

Drug: PF-06700841

PF-06700841 10 mg once daily followed by 60 mg once daily

Experimental group

Description:

PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52

Treatment:

Drug: PF-06700841

PF-06700841 10 mg once daily followed by 30 mg once daily

Experimental group

Description:

PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52

Treatment:

Drug: PF-06700841

Placebo once daily followed by 60 mg once daily

Placebo Comparator group

Description:

Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52

Treatment:

Other: Placebo

Placebo once daily followed by 30 mg once daily

Placebo Comparator group

Description:

Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52

Treatment:

Other: Placebo