Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (OPAL BEYOND)
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
Actual Study Start Date: August 2013
Actual Primary Completion Date: April 2016
Actual Study Completion Date: April 2016
Arms:
- Experimental: Treatment Sequence A
- Experimental: Treatment Sequence B
- Placebo Comparator: Treatment Sequence C
- Placebo Comparator: Treatment Sequence D
Related journals:
- Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors.
- Tofacitinib in psoriatic arthritis.
Category | Value |
---|---|
Date last updated at source | 2017-09-15 |
Study type(s) | Interventional |
Expected enrolment | 395 |
Study start date | 2013-08-01 |
Estimated primary completion date | 2016-04-01 |