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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

NCT01976364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2020-05-21

Study results available
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Summary

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Conditions

  • Arthritis, Psoriatic

Interventions

DRUG

Tofacitinib

Tofacitinib 5 mg tablet twice daily

DRUG

Tofacitinib

Tofactinib 10 mg tablet twice daily

DRUG

Methotrexate

Methotrexate 7.5-20 mg weekly

DRUG

Placebo Methotrexate

Placebo to match active methotrexate orally once a week

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-17
Primary Completion
2019-05-20
Completion
2019-05-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01976364 on ClinicalTrials.gov