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

Pfizer logo

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

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

Trial contacts and locations

125

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Data sourced from clinicaltrials.gov

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