Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT04517669
- Lead Sponsor
- Pfizer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
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
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2 at 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (50)
Hadassah University Hospital - Ein Kerem
🇮🇱Jerusalem, Israel
Hadassah Hebrew University Medical Center - Ein Kerem
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar- Sava, Israel
Galilee Medical Center
🇮🇱Nahariya, Israel
Rabin Mc Belinson Campus
🇮🇱Petach Tikva, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
CHU Clermont Ferrand - Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hôpital Henri Mondor
🇫🇷Creteil, France
CHR d'Annecy
🇫🇷Metz Tessy, France
Hopital Pasteur
🇫🇷Nice, France
CHR Orleans
🇫🇷Orleans Cedex 2, France
Hôpital Cochin
🇫🇷Paris cedex 14, France
Hôpital Saint-Antoine
🇫🇷Paris, France
Hopital Purpan
🇫🇷Toulouse, France
CHU Tours - Hôpital Trousseau
🇫🇷Tours Cedex, France
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Bnai Zion Medical Center
🇮🇱Haifa, Israel
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Rambam Health Care Center
🇮🇱Haifa, Israel
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Quironsalud Infanta Luisa
🇪🇸Sevilla, Spain
Lund University
🇸🇪Lund, Sweden
Skånes Universitetssjukhus, Malmö
🇸🇪Malmö, Sweden
Karolinska University Hospital, Solna
🇸🇪Stockholm, Sweden
Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten
🇸🇪Umeå, Sweden
Algemeen Stedelijk Ziekenhuis
🇧🇪Aalst, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
Nova Reuma Społka Partnerska
🇧🇪Genk, Belgium
Sygehus Vendsyssel Hospital
🇩🇰Hjørring, Denmark
Helsinki University Hospital
🇫🇮Helsinki, Finland
Pohjois-Kymen sairaala
🇫🇮Joensuu, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Turku University Hospital
🇫🇮Turku, Finland
CHU Besançon - Hôpital Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier Jean Rougier
🇫🇷Cahors, France
Infirmerie Protestante de Lyon
🇫🇷Caluire Et Cuire, France
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
The Baruch Padeh Medical Center - Poriya
🇮🇱Tiberias, Israel
Medisch Spectrum Twente, Haaksbergerstraat
🇳🇱Enschede, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
C.H. Universitario de Vigo- Hospital Meixoeiro
🇪🇸Vigo, Galicia, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
Hospital de Especialidades de Jerez de la Frontera
🇪🇸Cadiz, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain