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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03486457
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Treatment Sequence A

Tofacitinib 5 mg BID for 6 months

Placebo Comparator: Treatment Sequence B

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

Interventions

Drug: - Tofacitinib

tablets, 5 mg BID x 6 months

Other: - Placebo

tablets, to match tofacitinib 5 mg BID x 3 months

Drug: - Tofacitinib

tablets, 5 mg BID x 3 months

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bengbu, Anhui, China

Status

Active, not recruiting

Address

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004

Site Contact

Clinical Trial Finder