Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors (OPAL BEYOND)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Tofacitinib; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01882439

A3921125

2013-001368-46 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
• Active plaque psoriasis at screening
• Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion criteria

• Non-plaque forms of psoriasis (with exception of nail psoriasis)
• History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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395 participants in 4 patient groups, including a placebo group

Treatment Sequence A

Experimental group

Description:

Tofacitinib 5 mg BID for 6 months

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Treatment Sequence B

Experimental group

Description:

Tofacitinib 10 mg BID for 6 months

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Treatment Sequence C

Placebo Comparator group

Description:

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Other: Placebo

Other: Placebo

Drug: Tofacitinib

Treatment Sequence D

Placebo Comparator group

Description:

Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Treatment:

Drug: Tofacitinib

Drug: Tofacitinib

Drug: Tofacitinib

Other: Placebo

Other: Placebo

Drug: Tofacitinib