NCT01976364

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 686 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Tofacitinib	Tofacitinib 5 mg tablet twice daily
DRUG	Tofacitinib	Tofactinib 10 mg tablet twice daily
DRUG	Methotrexate	Methotrexate 7.5-20 mg weekly
DRUG	Placebo Methotrexate	Placebo to match active methotrexate orally once a week

Timeline

• Start date: 2014-02-17
• Primary completion: 2019-05-20
• Completion: 2019-05-20
• First posted: 2013-11-05
• Last updated: 2020-05-21
• Results posted: 2020-05-21

Locations

153 sites across 16 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Germany, Hungary, Mexico, Poland, Russia, Slovakia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study