Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
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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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This study will enroll approximately 500 patients from rheumatologists and/or PsA specialist centers in 10 countries (Belgium, Czech Republic, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden, and Switzerland) over an enrollment period of 12 months. The above list of countries are anticipated to participate in this study, however additional countries may be included at a later time. Each patient will have up to 12 months of follow-up for a total study duration of 24 months. Consecutive patients attending a routine clinical visit will be invited to participate if they meet the eligibility criteria for the study and are to start on treatment with tofacitinib for active PsA.
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 naïve 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)
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.