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

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04517669
• Other study ID #: A3921332
• Secondary ID: TOPSATI
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: July 22, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 22, 2024
• Est. primary completion date: July 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis	Aalst
Belgium	AZ Sint-Jan	Brugge
Belgium	Nova Reuma Spolka Partnerska	Genk
Denmark	Sygehus Vendsyssel Hospital	Hjørring
Finland	Helsinki University Hospital	Helsinki
Finland	Pohjois-Kymen sairaala	Joensuu
Finland	Oulu University Hospital	Oulu
Finland	Turku University Hospital	Turku
France	CHU Besançon - Hôpital Jean Minjoz	Besancon
France	Centre Hospitalier Jean Rougier	Cahors
France	Infirmerie Protestante de Lyon	Caluire Et Cuire
France	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 Saint-Antoine	Paris
France	Hôpital Cochin	Paris cedex 14
France	Hopital Purpan	Toulouse
France	CHU Tours - Hôpital Trousseau	Tours Cedex
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Center	Haifa
Israel	The Lady Davis Carmel Medical Center	Haifa
Israel	Hadassah Hebrew University Medical Center - Ein Kerem	Jerusalem
Israel	Hadassah University Hospital - 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	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	The Baruch Padeh Medical Center - Poriya	Tiberias
Netherlands	Medisch Spectrum Twente, Haaksbergerstraat	Enschede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Spain	Hospital de Especialidades de Jerez de la Frontera	Cadiz
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	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 Quironsalud Infanta Luisa	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	C.H. Universitario de Vigo- Hospital Meixoeiro	Vigo	Galicia
Sweden	Lund University	Lund
Sweden	Skånes Universitetssjukhus, Malmö	Malmö
Sweden	Karolinska University Hospital, Solna	Stockholm
Sweden	Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

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

External Links

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