Clinical trial NCT04517669: Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice
Official title: A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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)

Primary outcomes:
measure: Proportion of patients achievinglow disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2
timeFrame: at 6 months
Secondary outcomes:
measure: Proportion of patients achieving low disease activity (LDA) defined as psoriatic arthritis disease activity score (PASDAS) score ≤3.2
timeFrame: at 3 and 12 Months
measure: Proportion of patients achieving minimal disease activity (MDA) defined as at least 5 of 7 criteria met
timeFrame: Months 3, 6, 12
measure: Proportion of patients achieving remission defined as psoriatic arthritis disease activity score (PASDAS) score ≤1.9
timeFrame: Months 3, 6, 12
measure: Proportion of patients achieving remission defined as disease activity in psoriatic arthritis (DAPSA) score ≤4.0
timeFrame: Months 3, 6,12
measure: Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID12) score
timeFrame: Months 3, 6,12
measure: Change from baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) score
timeFrame: Months 3, 6,12
measure: Proportion of patients achieving low disease activity (LDA) at Months 3, 6, and 12 based on presence of prognostic factors
timeFrame: Months 3, 6, 12
measure: Change from baseline in quality of life (QoL) using Patient reported outcomes (PRO ) scores
timeFrame: Months 3, 6,12
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Genk
country: Belgium
facility: Nova Reuma Społka Partnerska
city: Hjørring
country: Denmark
facility: Sygehus Vendsyssel Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Joensuu
country: Finland
facility: Pohjois-Kymen sairaala
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Besancon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougier
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante de Lyon
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Metz Tessy
country: France
facility: CHR d'Annecy
city: Nice
country: France
facility: Hopital Pasteur
city: Orleans Cedex 2
country: France
facility: CHR Orleans
city: Paris cedex 14
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Toulouse
country: France
facility: Hopital Purpan
city: Tours Cedex
country: France
facility: CHU Tours - Hôpital Trousseau
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Ein Kerem
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center - Ein Kerem
city: Kfar- Sava
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Mc Belinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tiberias
country: Israel
facility: The Baruch Padeh Medical Center - Poriya
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente, Haaksbergerstraat
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Vigo
country: Spain
facility: C.H. Universitario de Vigo- Hospital Meixoeiro
state: Galicia
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Cadiz
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Lund
country: Sweden
facility: Lund University
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus, Malmö
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
city: Umeå
country: Sweden
facility: Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: