Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tofacitinib — DRUG
  tablets, 5 mg BID x 6 months
• Tofacitinib — DRUG
  tablets, 10 mg BID x 6 months
• Placebo — OTHER
  tablets, to match tofacitinib 5 mg BID x 3 months
• Tofacitinib — DRUG
  tablets, 5 mg BID x 3 months
• Placebo — OTHER
  tablets, to match tofacitinib 10 mg BID x 3 months
• Tofacitinib — DRUG
  tablets, 10 mg BID x 3 months

Study Details

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.

Key Dates

Start date

Aug 31, 2013

Status verified

Sep 2017

Primary completion

Apr 30, 2016

Completion

Apr 30, 2016

Study Design

Enrollment

395 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Sequence A
  Tofacitinib 5 mg BID for 6 months
• Experimental: Treatment Sequence B
  Tofacitinib 10 mg BID for 6 months
• Placebo Comparator: Treatment Sequence C
  Placebo for 3 months then tofacitinib 5 mg BID for 3 months
• Placebo Comparator: Treatment Sequence D
  Placebo for 3 months then tofacitinib 10 mg BID for 3 months

Primary Outcome Measure

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3 [ Time Frame: Month 3 ]

Locations (43)

Find similar trials in Birmingham, AL

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