Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Other: Placebo; Drug: Tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03486457

A3921234

Details and patient eligibility

About

This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese patients
• Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
• Active plaque psoriasis at screening
• Inadequate response to at least one conventional synthetic DMARD

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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204 participants in 2 patient groups, including a placebo group

Treatment Sequence A

Experimental group

Description:

Tofacitinib 5 mg BID for 6 months

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

Treatment Sequence B

Placebo Comparator group

Description:

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Treatment:

Drug: Tofacitinib

Other: Placebo

Drug: Tofacitinib