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Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

NCT01882439 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 395

Last updated 2017-09-15

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Tofacitinib

tablets, 5 mg BID x 6 months

DRUG

Tofacitinib

tablets, 10 mg BID x 6 months

OTHER

Placebo

tablets, to match tofacitinib 5 mg BID x 3 months

DRUG

Tofacitinib

tablets, 5 mg BID x 3 months

OTHER

Placebo

tablets, to match tofacitinib 10 mg BID x 3 months

DRUG

Tofacitinib

tablets, 10 mg BID x 3 months

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01882439 on ClinicalTrials.gov