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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04517669
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Denmark, Finland, France, Israel, Netherlands, Spain, Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Algemeen Stedelijk Ziekenhuis, Aalst, Belgium

Status

Recruiting

Address

Algemeen Stedelijk Ziekenhuis

Aalst, , 9300

AZ Sint-Jan, Brugge, Belgium

Status

Recruiting

Address

AZ Sint-Jan

Brugge, , 8000

Nova Reuma Społka Partnerska, Genk, Belgium

Status

Recruiting

Address

Nova Reuma Społka Partnerska

Genk, , 3600

Sygehus Vendsyssel Hospital, Hjørring, Denmark

Status

Recruiting

Address

Sygehus Vendsyssel Hospital

Hjørring, ,

Helsinki University Hospital, Helsinki, Finland

Status

Not yet recruiting

Address

Helsinki University Hospital

Helsinki, ,

Pohjois-Kymen sairaala, Joensuu, Finland

Status

Not yet recruiting

Address

Pohjois-Kymen sairaala

Joensuu, ,

Oulu University Hospital, Oulu, Finland

Status

Not yet recruiting

Address

Oulu University Hospital

Oulu, ,

Turku University Hospital, Turku, Finland

Status

Recruiting

Address

Turku University Hospital

Turku, ,

CHU Besançon - Hôpital Jean Minjoz, Besancon, France

Status

Recruiting

Address

CHU Besançon - Hôpital Jean Minjoz

Besancon, , 25000

Centre Hospitalier Jean Rougier, Cahors, France

Status

Recruiting

Address

Centre Hospitalier Jean Rougier

Cahors, , 46000

Infirmerie Protestante de Lyon, Caluire Et Cuire, France

Status

Recruiting

Address

Infirmerie Protestante de Lyon

Caluire Et Cuire, , 69300

Clermont-Ferrand, France

Status

Recruiting

Address

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, , 63000

Hôpital Henri Mondor, Creteil, France

Status

Not yet recruiting

Address

Hôpital Henri Mondor

Creteil, , 94010

CHR d'Annecy, Metz Tessy, France

Status

Not yet recruiting

Address

CHR d'Annecy

Metz Tessy, , 74370

Hopital Pasteur, Nice, France

Status

Recruiting

Address

Hopital Pasteur

Nice, , 6001

CHR Orleans, Orleans Cedex 2, France

Status

Recruiting

Address

CHR Orleans

Orleans Cedex 2, , 45067

Hôpital Cochin, Paris cedex 14, France

Status

Not yet recruiting

Address

Hôpital Cochin

Paris cedex 14, , 75679

Hôpital Saint-Antoine, Paris, France

Status

Not yet recruiting

Address

Hôpital Saint-Antoine

Paris, , 75012

Hopital Purpan, Toulouse, France

Status

Recruiting

Address

Hopital Purpan

Toulouse, , 31059

CHU Tours - Hôpital Trousseau, Tours Cedex, France

Status

Recruiting

Address

CHU Tours - Hôpital Trousseau

Tours Cedex, , 37044

Barzilai Medical Center, Ashkelon, Israel

Status

Recruiting

Address

Barzilai Medical Center

Ashkelon, ,

Soroka University Medical Center, Beer-Sheva, Israel

Status

Recruiting

Address

Soroka University Medical Center

Beer-Sheva, , 84001

Bnai Zion Medical Center, Haifa, Israel

Status

Recruiting

Address

Bnai Zion Medical Center

Haifa, , 31048

The Lady Davis Carmel Medical Center, Haifa, Israel

Status

Recruiting

Address

The Lady Davis Carmel Medical Center

Haifa, , 3436212

Rambam Health Care Center, Haifa, Israel

Status

Recruiting

Address

Rambam Health Care Center

Haifa, ,

Hadassah University Hospital - Ein Kerem, Jerusalem, Israel

Status

Recruiting

Address

Hadassah University Hospital - Ein Kerem

Jerusalem, , 246000

Jerusalem, Israel

Status

Recruiting

Address

Hadassah Hebrew University Medical Center - Ein Kerem

Jerusalem, , 91120

Meir Medical Center, Kfar- Sava, Israel

Status

Not yet recruiting

Address

Meir Medical Center

Kfar- Sava, ,

Galilee Medical Center, Nahariya, Israel

Status

Recruiting

Address

Galilee Medical Center

Nahariya, ,

Rabin Mc Belinson Campus, Petach Tikva, Israel

Status

Not yet recruiting

Address

Rabin Mc Belinson Campus

Petach Tikva, ,

Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Chaim Sheba Medical Center

Ramat Gan, , 52621

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, ,

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, ,

The Baruch Padeh Medical Center - Poriya, Tiberias, Israel

Status

Recruiting

Address

The Baruch Padeh Medical Center - Poriya

Tiberias, , 15208

Enschede, Netherlands

Status

Recruiting

Address

Medisch Spectrum Twente, Haaksbergerstraat

Enschede, , 7512 KZ

Medisch Centrum Leeuwarden, Leeuwarden, Netherlands

Status

Recruiting

Address

Medisch Centrum Leeuwarden

Leeuwarden, ,

Vigo, Galicia, Spain

Status

Recruiting

Address

C.H. Universitario de Vigo- Hospital Meixoeiro

Vigo, Galicia, 36200

Hospital Universitario Puerta del Mar, Cadiz, Spain

Status

Recruiting

Address

Hospital Universitario Puerta del Mar

Cadiz, , 11009

Cadiz, Spain

Status

Recruiting

Address

Hospital de Especialidades de Jerez de la Frontera

Cadiz, , 11407

Hospital Universitario Reina Sofia, Cordoba, Spain

Status

Recruiting

Address

Hospital Universitario Reina Sofia

Cordoba, , 14004

Hospital Universitario San Cecilio, Granada, Spain

Status

Recruiting

Address

Hospital Universitario San Cecilio

Granada, , 18012

Granada, Spain

Status

Recruiting

Address

Hospital Universitario Virgen de las Nieves

Granada, , 18014

Malaga, Spain

Status

Recruiting

Address

Hospital Regional Universitario de Malaga

Malaga, , 29010

Oviedo, Spain

Status

Recruiting

Address

Hospital Universitario Central de Asturias

Oviedo, , 33011

Hospital Universitario Virgen Macarena, Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena

Sevilla, , 41009

Hospital Quironsalud Infanta Luisa, Sevilla, Spain

Status

Recruiting

Address

Hospital Quironsalud Infanta Luisa

Sevilla, , 41010

Lund University, Lund, Sweden

Status

Recruiting

Address

Lund University

Lund, ,

Skånes Universitetssjukhus, Malmö, Malmö, Sweden

Status

Recruiting

Address

Skånes Universitetssjukhus, Malmö

Malmö, ,

Karolinska University Hospital, Solna, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital, Solna

Stockholm, ,

Umeå, Sweden

Status

Recruiting

Address

Norrlands University Hospital Umeå, Reumatologiska kliniken Västerbotten

Umeå, ,

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