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

NCT ID: NCT04517669

Last Updated: 2025-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2024-07-30

Brief Summary

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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

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Algemeen Stedelijk Ziekenhuis

Aalst, , Belgium

Site Status

AZ Sint-Jan

Bruges, , Belgium

Site Status

Nova Reuma Społka Partnerska

Genk, , Belgium

Site Status

Sygehus Vendsyssel Hospital

Hjørring, , Denmark

Site Status

Turku University Hospital

Turku, , Finland

Site Status

CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

Site Status

Centre Hospitalier Jean Rougier

Cahors, , France

Site Status

Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Site Status

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Hopital Pasteur

Nice, , France

Site Status

CHR Orleans

Orléans, , France

Site Status

Hopital Purpan

Toulouse, , France

Site Status

CHU Tours - Hôpital Trousseau

Tours, , France

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Bnai Zion Medical Center

Haifa, , Israel

Site Status

The Lady Davis Carmel Medical Center

Haifa, , Israel

Site Status

Rambam Health Care Center

Haifa, , Israel

Site Status

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Site Status

Hadassah Hebrew University Medical Center - Ein Kerem

Jerusalem, , Israel

Site Status

Galilee Medical Center

Nahariya, , Israel

Site Status

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

The Baruch Padeh Medical Center - Poriya

Tiberias, , Israel

Site Status

Medisch Spectrum Twente, Haaksbergerstraat

Enschede, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

C.H. Universitario de Vigo- Hospital Meixoeiro

Vigo, Galicia, Spain

Site Status

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status

Hospital de Especialidades de Jerez de la Frontera

Cadiz, , Spain

Site Status

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status

Hospital Universitario San Cecilio

Granada, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Regional Universitario de Malaga

Málaga, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Quironsalud Infanta Luisa

Seville, , Spain

Site Status

Lund University

Lund, , Sweden

Site Status

Skånes Universitetssjukhus, Malmö

Malmo, , Sweden

Site Status

Karolinska University Hospital, Solna

Stockholm, , Sweden

Site Status

Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

Umeå, , Sweden

Site Status

Countries

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Belgium Denmark Finland France Israel Netherlands Spain Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921332

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

Other Identifiers

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TOPSATI

Identifier Type: OTHER

Identifier Source: secondary_id

A3921332

Identifier Type: -

Identifier Source: org_study_id

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