Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Key facts

Study ID

NCT01976364

Run by

Pfizer

People needed

686

Starts

2014-02-17

Expected to finish

2019-05-20

Last updated by the study team

2020-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous participation in qualifying PsA study involving tofacitinib

You may not qualify if…

• Time from End of Study visit of qualifying study is >3 months.
• Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.
• Sub-study Inclusion Criteria:
• Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study
• Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
• Sub-study Exclusion Criteria:
• Subjects who are receiving methotrexate by a route other than oral

Where it is running

• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Glendale, Arizona, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Stanford Anatomic Pathology and Clinical Lab — Stanford, California, United States
• Stanford Health Care Department of Pharmacy lnvestigational Drug Services — Stanford, California, United States
• Stanford University Hospitals and Clinics — Stanford, California, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• Rheumatology Associates of Central Florida, PA — Orlando, Florida, United States
• Millennium Research — Ormond Beach, Florida, United States
• Arthritis Center, Inc. — Palm Harbour, Florida, United States
• Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Florida Medical Clinic, P.A. — Zephyrhills, Florida, United States
• St. Luke's Clinic - Rheumatology — Boise, Idaho, United States
• St. Luke's Intermountain Research Center — Boise, Idaho, United States
• Bluegrass Community Research, Inc. — Lexington, Kentucky, United States
• Klein and Associates, M.D., P.A. — Hagerstown, Maryland, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• St. Paul Rheumatology, P.A. — Eagan, Minnesota, United States
• Clayton Medical Research — St Louis, Missouri, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Rheumatology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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