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Clinical trial

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

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Last updated:20th Jan 2014
Identifier: NCT01877668

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


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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) Or Adalimumab In Subjects With Active Psoriatic Arthritis
Actual Study Start Date: January 20, 2014
Actual Primary Completion Date: December 18, 2015
Actual Study Completion Date: December 18, 2015

Arms:
- Experimental:
Tofacitinib 5 mgBID x 12 months
- Experimental: Tofacitinib 10 mg BID x 12 months
- Active Comparator: Adalimumab 40 mg q2 weeks x 12 months
- Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
- Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months


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 2017-07-06
Study type(s) Interventional
Expected enrolment 422
Study start date 2014-01-20
Estimated primary completion date 2015-12-18

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