A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Study Purpose

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

Recruitment Criteria

Accepts Healthy Volunteers

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

Unknown
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
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have a confirmed diagnosis of PsA as determined by a rheumatologist with reference to Classification criteria for Psoriatic Arthritis (CASPAR) - Start guselkumab or any approved IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy for the indication of PsA as part of standard clinical practice (according to local label, local regulations, and/or reimbursement requirements) at the time of enrollment into the observational study or within a maximum of 2 months after the initial baseline visit or after repeated baseline data collection.
  • - Sign a participation agreement/Informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements.
  • - Able to read, understand, and intend to comply with completion of all Electronic patient-reported outcome (ePRO) instruments.
  • - The treatment decision must be taken by the participating rheumatologist prior to, and independently of the participant's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations.

Exclusion Criteria:

  • - Start guselkumab or an IL-17i therapy as fifth or further line of biologic treatment.
  • - Have already taken a specific IL-17i or IL-23i treatment and are planning on re-taking that specific treatment again.
  • - Unwilling or unable to participate in long-term data collection.
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study (that is, signing of informed consent) - Currently enrolled in any interventional study or any Janssen-sponsored observational clinical study (contemporary participation into observational studies or registries not sponsored by Janssen is acceptable)

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.

NCT05049798
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.

Janssen Pharmaceutica N.V., Belgium
Principal Investigator

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

Janssen Pharmaceutica N.V., Belgium Clinical Trial
Principal Investigator Affiliation Janssen Pharmaceutica N.V., Belgium
Agency Class

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

Industry
Overall Status Recruiting
Countries Austria, France, Germany, Italy, Russian Federation, Spain, Sweden, United Kingdom
Conditions

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

Arthritis, Psoriatic
Study Website: View Trial Website
Arms & Interventions

Arms

: Cohort 1: Guselkumab

Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of Psoriatic Arthritis (PsA) who are starting guselkumab as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice.

: Cohort 2: Interleukin-17 inhibitor (IL-17i)

Data as available from participant's source medical records will be collected for adult participants with a confirmed diagnosis of PsA who are starting IL-17i as a first, second, third, or fourth line of PsA biologic therapy either as monotherapy or with other medications per routine clinical practice.

Interventions

Drug: - Guselkumab

Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with guselkumab, will be observed according to standard clinical practice.

Drug: - IL-17i

Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with IL-17i, will be observed according to standard clinical practice.

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

Barmherzige Brüder Krankenhaus Graz, Graz, Austria

Status

Not yet recruiting

Address

Barmherzige Brüder Krankenhaus Graz

Graz, , 8020

Praxis Prim. Priv.Doz. Dr. Burkhard Leeb, Hollabrunn, Austria

Status

Withdrawn

Address

Praxis Prim. Priv.Doz. Dr. Burkhard Leeb

Hollabrunn, , 2020

Kepler Universitätsklinikum GmbH, Linz, Austria

Status

Not yet recruiting

Address

Kepler Universitätsklinikum GmbH

Linz, , 4021

LK Weinviertel Stockerau, Stockerau, Austria

Status

Withdrawn

Address

LK Weinviertel Stockerau

Stockerau, , 2000

Medizinische Universität Wien, Vienna, Austria

Status

Recruiting

Address

Medizinische Universität Wien

Vienna, , 1090

Wien, Austria

Status

Recruiting

Address

Evang. Krankenhaus Gemein. Betriebgesm. Mbh

Wien, , A-1100

Hôpital Pellegrin CHU Bordeaux, Bordeaux, France

Status

Not yet recruiting

Address

Hôpital Pellegrin CHU Bordeaux

Bordeaux, ,

Creteil, France

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

Creteil, , 94000

Hôpital Pitié-Salpétrière, Paris, France

Status

Not yet recruiting

Address

Hôpital Pitié-Salpétrière

Paris, , 75651

Hopital Purpan, Toulouse, France

Status

Not yet recruiting

Address

Hopital Purpan

Toulouse, , 31059

Rheuma-Praxis Bayreuth, Bayreuth, Germany

Status

Recruiting

Address

Rheuma-Praxis Bayreuth

Bayreuth, , 95444

Rheumatologische Schwerpunktpraxis, Berlin, Germany

Status

Recruiting

Address

Rheumatologische Schwerpunktpraxis

Berlin, , 12161

Burghausen, Germany

Status

Withdrawn

Address

Schwerpunktpraxis für Rheumatologie und Klinische Immunologi

Burghausen, , 84489

Universitätsklinikum Düsseldorf, Dusseldorf, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Düsseldorf

Dusseldorf, , 40225

Universitatsklinikum Frankfurt, Frankfurt, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt, , 60590

Rheumapraxis Dr. Liebhaber, Halle-Saale, Germany

Status

Not yet recruiting

Address

Rheumapraxis Dr. Liebhaber

Halle-Saale, , 6128

Hamburg, Germany

Status

Recruiting

Address

Praxis fur Klinische Studien und Praxis fur Orthopadie

Hamburg, , 22415

Rheumatologie im Struenseehaus, Hamburg, Germany

Status

Recruiting

Address

Rheumatologie im Struenseehaus

Hamburg, , 22767

Rheumazentrum Ruhrgebiet, Herne, Germany

Status

Recruiting

Address

Rheumazentrum Ruhrgebiet

Herne, , 44649

Krankenhaus Porz am Rhein, Koln, Germany

Status

Not yet recruiting

Address

Krankenhaus Porz am Rhein

Koln, , 51149

Rheumatologische Praxis, Leipzig, Germany

Status

Recruiting

Address

Rheumatologische Praxis

Leipzig, , 04109

Rheumatologische Praxis, Magdeburg, Germany

Status

Recruiting

Address

Rheumatologische Praxis

Magdeburg, , 39104

Praxiszentrum St. Bonifatius, München, Germany

Status

Recruiting

Address

Praxiszentrum St. Bonifatius

München, , 81541

Praxis Thilo Klopsch, Neubrandenburg, Germany

Status

Recruiting

Address

Praxis Thilo Klopsch

Neubrandenburg, , 17033

Rheumazentrum Ratingen, Ratingen, Germany

Status

Not yet recruiting

Address

Rheumazentrum Ratingen

Ratingen, , 40878

Vogelsang-Gommern, Germany

Status

Not yet recruiting

Address

Immunologisches Zentrum Vogelsang-Gommern GmbH

Vogelsang-Gommern, , 39245

Campobasso, Italy

Status

Not yet recruiting

Address

Ospedale Regionale Cardarelli-Università degli Studi del Mol

Campobasso, , 86100

Istituto Clinico Humanitas, Rozzano, Italy

Status

Not yet recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20156

Torino, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , 10126

SBEU HPE Kemerovo State Medical Academy, Kemerovo, Russian Federation

Status

Not yet recruiting

Address

SBEU HPE Kemerovo State Medical Academy

Kemerovo, , G4 0SF

Moscow, Russian Federation

Status

Not yet recruiting

Address

Bakoulev Scientific Center For Cardiovascular Surgery Rams

Moscow, , 121552

Moscow, Russian Federation

Status

Not yet recruiting

Address

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, , 190068

Saint Petersburg, Russian Federation

Status

Not yet recruiting

Address

North-Western State Medical University named I.I. Mechnikov

Saint Petersburg, ,

City Hospital #3, Tomsk, Russian Federation

Status

Not yet recruiting

Address

City Hospital #3

Tomsk, , 634045

Hosp. Univ. A Coruña, A Coruña, Spain

Status

Not yet recruiting

Address

Hosp. Univ. A Coruña

A Coruña, , 15006

Hosp. Clinic I Provincial de Barcelona, Barcelona, Spain

Status

Not yet recruiting

Address

Hosp. Clinic I Provincial de Barcelona

Barcelona, , 08036

Hosp. Univ. de Basurto, Bilbao, Spain

Status

Not yet recruiting

Address

Hosp. Univ. de Basurto

Bilbao, , 48013

Hosp. Gral. Univ. de Castellon, Castellon, Spain

Status

Not yet recruiting

Address

Hosp. Gral. Univ. de Castellon

Castellon, , 12004

Hosp. Gral. Univ. de Elche, Elche, Spain

Status

Not yet recruiting

Address

Hosp. Gral. Univ. de Elche

Elche, , 03203

Complejo hospitalario de Granada, Granada, Spain

Status

Not yet recruiting

Address

Complejo hospitalario de Granada

Granada, , 18016

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Univ. de Getafe, Madrid, Spain

Status

Not yet recruiting

Address

Hosp. Univ. de Getafe

Madrid, , 28905

Hosp. Univ. Central de Asturias, Oviedo, Spain

Status

Not yet recruiting

Address

Hosp. Univ. Central de Asturias

Oviedo, , 33011

Universitetssjukhuset Örebro, Orebro, Sweden

Status

Recruiting

Address

Universitetssjukhuset Örebro

Orebro, , 70185

Stockholm, Sweden

Status

Recruiting

Address

Akademiskt Specialistcentrum centrum för reumatologi

Stockholm, , 113 65

Akademiska Sjukhuset, Uppsala, Sweden

Status

Recruiting

Address

Akademiska Sjukhuset

Uppsala, , 75185

Nevill Hall Hospital, Abergavenny, United Kingdom

Status

Not yet recruiting

Address

Nevill Hall Hospital

Abergavenny, , NP7 7EG

Wolfson Centre Royal United Hospitals, Bath, United Kingdom

Status

Not yet recruiting

Address

Wolfson Centre Royal United Hospitals

Bath, , BA1 3NG

Glasgow Royal Infirmary, Glasgow, United Kingdom

Status

Not yet recruiting

Address

Glasgow Royal Infirmary

Glasgow, , 650029

Hull Royal Infirmary, Hull, United Kingdom

Status

Not yet recruiting

Address

Hull Royal Infirmary

Hull, , HU3 2JZ

Chapel Allerton Hospital, Leeds, United Kingdom

Status

Not yet recruiting

Address

Chapel Allerton Hospital

Leeds, , LS7 4SA

Kings College Hospital, London, United Kingdom

Status

Not yet recruiting

Address

Kings College Hospital

London, , SE5 9RS

Manchester, United Kingdom

Status

Not yet recruiting

Address

Central Manchester University Hospitals NHS Foundation Trust

Manchester, , M13 9WL

Newcastle Upon Tyne, United Kingdom

Status

Not yet recruiting

Address

The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit

Newcastle Upon Tyne, , NE7 7DN

Southampton General Hospital, Southampton, United Kingdom

Status

Not yet recruiting

Address

Southampton General Hospital

Southampton, , SO16 6YD

Haywood Hospital, Staffordshire, United Kingdom

Status

Not yet recruiting

Address

Haywood Hospital

Staffordshire, , ST6 7AG

Stamford and Rutland hospital, Stamford, United Kingdom

Status

Not yet recruiting

Address

Stamford and Rutland hospital

Stamford, , PE9 1UA

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