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

NCT04517669

CompletedN/A

Sponsor: Pfizer

Conditions: Psoriatic Arthritis

Countries: Belgium, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden

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

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients aged ≥ 18 years
2. Moderate to severe PsA disease activity diagnosed
3. 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
4. Patients are treatment naïve to tofacitinib on the date of providing informed consent
5. 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
6. 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:

1. Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
2. Receipt of any investigational drug within 3 months before study inclusion
3. Patient is pregnant or breastfeeding
4. Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
5. Active treatment for a malignancy
6. Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
Locations (41)
  • Aalst, Belgium
  • Bruges, Belgium
  • Genk, Belgium
  • Hjørring, Denmark
  • Turku, Finland
  • Besançon, France
  • Cahors, France
  • Caluire-et-Cuire, France
  • Clermont-Ferrand, France
  • Nice, France
  • Orléans, France
  • Toulouse, France
  • Tours, France
  • Ashkelon, Israel
  • Beersheba, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Jerusalem, Israel
  • Jerusalem, Israel
  • Nahariya, Israel
  • Ramat Gan, Israel
  • Ramat Gan, Israel
  • Tel Aviv, Israel
  • Tiberias, Israel
  • Enschede, Netherlands
  • Leeuwarden, Netherlands
  • Vigo, Galicia, Spain
  • Cadiz, Spain
  • Cadiz, Spain
  • + 11 more on CT.gov