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

Pfizer logo

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

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

Trial documents
2

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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