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Clinical trial

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

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Last updated:17th Feb 2014
Identifier: NCT01976364

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.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 650 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The sub-study will be participant, care provider, investigator and outcomes assessor masked.
Primary Purpose: Treatment
Official Title: A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis
Actual Study Start Date: February 17, 2014
Estimated Primary Completion Date: August 1, 2019
Estimated Study Completion Date: August 1, 2019

- Experimental:

Category Value
Date last updated at source 2018-06-08
Study type(s) Interventional
Expected enrolment 650
Study start date 2014-02-17
Estimated primary completion date 2019-08-01

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