Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

• Status: Completed
• Trial end date: 2019-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Methotrexate; Tofacitinib

Criteria

Inclusion Criteria:

• Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

• 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