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

A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis

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

Study Overview

• Status: Recruiting
• Conditions: Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • Algemeen Stedelijk Ziekenhuis
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Jan
  • Genk, Belgium, 3600
    • Recruiting
    • Nova Reuma Społka Partnerska
• Denmark
  • Hjørring, Denmark
    • Recruiting
    • Sygehus Vendsyssel Hospital
• Finland
  • Helsinki, Finland
    • Not yet recruiting
    • Helsinki University Hospital
  • Joensuu, Finland
    • Not yet recruiting
    • Pohjois-Kymen sairaala
  • Oulu, Finland
    • Not yet recruiting
    • Oulu University Hospital
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
• France
  • Besancon, France, 25000
    • Recruiting
    • CHU Besançon - Hôpital Jean Minjoz
  • Cahors, France, 46000
    • Recruiting
    • Centre Hospitalier Jean Rougier
  • Caluire Et Cuire, France, 69300
    • Recruiting
    • Infirmerie Protestante de Lyon
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Creteil, France, 94010
    • Not yet recruiting
    • Hopital Henri Mondor
  • Metz Tessy, France, 74370
    • Not yet recruiting
    • CHR d'Annecy
  • Nice, France, 6001
    • Recruiting
    • Hôpital Pasteur
  • Orleans Cedex 2, France, 45067
    • Recruiting
    • CHR Orleans
  • Paris, France, 75012
    • Not yet recruiting
    • Hopital Saint-Antoine
  • Paris cedex 14, France, 75679
    • Not yet recruiting
    • Hôpital Cochin
  • Toulouse, France, 31059
    • Recruiting
    • Hopital Purpan
  • Tours Cedex, France, 37044
    • Recruiting
    • CHU Tours - Hôpital Trousseau
• Israel
  • Ashkelon, Israel
    • Recruiting
    • Barzilai Medical Center
  • Beer-Sheva, Israel, 84001
    • Recruiting
    • Soroka University Medical Center
  • Haifa, Israel, 31048
    • Recruiting
    • Bnai Zion Medical Center
  • Haifa, Israel
    • Recruiting
    • Rambam Health Care Center
  • Haifa, Israel, 3436212
    • Recruiting
    • The Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 246000
    • Recruiting
    • Hadassah University Hospital - Ein Kerem
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Hebrew University Medical Center - Ein Kerem
  • Kfar- Sava, Israel
    • Not yet recruiting
    • Meir Medical Center
  • Nahariya, Israel
    • Recruiting
    • Galilee Medical Center
  • Petach Tikva, Israel
    • Not yet recruiting
    • Rabin Mc Belinson Campus
  • Ramat Gan, Israel, 52621
    • Recruiting
    • Chaim Sheba Medical Center
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center
  • Tiberias, Israel, 15208
    • Recruiting
    • The Baruch Padeh Medical Center - Poriya
• Netherlands
  • Enschede, Netherlands, 7512 KZ
    • Recruiting
    • Medisch Spectrum Twente, Haaksbergerstraat
  • Leeuwarden, Netherlands
    • Recruiting
    • Medisch Centrum Leeuwarden
• Spain
  • Cadiz, Spain, 11009
    • Recruiting
    • Hospital Universitario Puerta del Mar
  • Cadiz, Spain, 11407
    • Recruiting
    • Hospital de Especialidades de Jerez de la Frontera
  • Cordoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
  • Granada, Spain, 18012
    • Recruiting
    • Hospital Universitario San Cecilio
  • Malaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Málaga
  • Oviedo, Spain, 33011
    • Recruiting
    • Hospital Universitario Central de Asturias
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41010
    • Recruiting
    • Hospital Quironsalud Infanta Luisa
  • Galicia
    • Vigo, Galicia, Spain, 36200
      • Recruiting
      • C.H. Universitario de Vigo- Hospital Meixoeiro
• Sweden
  • Lund, Sweden
    • Recruiting
    • Lund University
  • Malmö, Sweden
    • Recruiting
    • Skånes Universitetssjukhus, Malmö
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital, Solna
  • Umeå, Sweden
    • Recruiting
    • Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving low disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2	at 3 and 12 Months
Proportion of patients achieving minimal disease activity (MDA) defined as at least 5 of 7 criteria met	Months 3, 6, 12
Proportion of patients achieving remission defined as psoriatic arthritis disease activity score (PASDAS) score ≤1.9	Months 3, 6, 12
Proportion of patients achieving remission defined as disease activity in psoriatic arthritis (DAPSA) score ≤4.0	Months 3, 6,12
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID12) score	Months 3, 6,12
Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) score	Months 3, 6,12
Proportion of patients achieving low disease activity (LDA) at Months 3, 6, and 12 based on presence of prognostic factors	Months 3, 6, 12
Change from baseline in quality of life (QoL) using Patient reported outcomes (PRO ) scores	Months 3, 6,12

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): July 22, 2024
• Study Completion (Estimated): July 22, 2024

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: A3921332; TOPSATI (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.