Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    500
  • sponsor
    Pfizer
Updated on 24 July 2021
tofacitinib
arthritis
DMARD

Summary

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Arthritis
Clinical Study IdentifierNCT04517669
SponsorPfizer
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must meet all of the following inclusion criteria
to be eligible for inclusion in the study
Patients aged 18 years
Moderate to severe PsA disease activity diagnosed
Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
Patients are treatment nave to tofacitinib on the date of providing informed consent
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
Patients on DMARDs must have not had a treatment change in the past 3 months

Exclusion Criteria

Patients meeting any of the following criteria will not be
included in the study
Contraindications according to the Xeljanz (tofacitinib) Prescribing Information
Receipt of any investigational drug within 3 months before study inclusion
Patient is pregnant or breastfeeding
Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
Active treatment for a malignancy
Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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