Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriatic Arthritis

In brief

This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Key facts

Study ID

NCT01877668

Run by

Pfizer

People needed

422

Starts

2014-01-20

Expected to finish

2015-12-18

Last updated by the study team

2017-07-06

Who can join

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

You may qualify if…

• Males or females, aged >= 18 years at time of consent.
• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
• Meet the Classification Criteria of PsA (CASPAR) at time of screening
• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
• Must not have taken a biologic Tumour Necrosis Factor Inhibitor
• Must have 3 or more swollen joints AND 3 or more tender joints
• Must have active psoriasis skin lesions

You may not qualify if…

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
• New York Heart Association Class III and IV congestive heart failure
• History of hypersensitivity or infusion reaction to biologic agents
• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Where it is running

• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Glendale, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• Advances In Medicine (X-Rays) — Rancho Mirage, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Millennium Research — Ormond Beach, Florida, United States
• Arthritis Center, Inc. — Palm Harbor, Florida, United States
• Klein & Associates, M.D., P.A. — Hagerstown, Maryland, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• St. Paul Rheumatology, PA — Eagan, Minnesota, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Dartmouth-Hitchcock Medical Center (DHMC) — Lebanon, New Hampshire, United States
• Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Low Country Rheumatology, PA — Charleston, South Carolina, United States
• Pioneer Research Solutions, Inc. — Houston, Texas, United States
• Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah — Salt Lake City, Utah, United States
• University of Utah Hospital & Clinics — Salt Lake City, Utah, United States
• Dynacare Laboratories (Specimen processing for shipment) — Seattle, Washington, United States
• Investigational Drug Service Pharmacy, Swedish Medical Center. — Seattle, Washington, United States
• Seattle Rheumatology Associates — Seattle, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States
• Rheumatology Research Unit — Maroochydore, Queensland, Australia
• Rheumatology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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