A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis

Study Purpose

The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

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
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria - Must be starting either STELARA or any new approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilar) as a new biologic disease-modifying antirheumatic drug (bDMARD) therapy in a first, second or third line of bDMARD therapy for PsA at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit - Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

- Participant is starting STELARA or a TNFi therapy as fourth or further line of biologic treatment - Participant is unwilling or unable to participate in long-term data collection - Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point - Participant is currently enrolled in an interventional study

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.	NCT02627768
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	Belgium, France, Greece, Italy, Netherlands, Russian Federation, Spain, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis
Study Website:	View Trial Website

Additional Details

This is a prospective, observational, cohort study to collect data on adult participants who have a confirmed diagnosis of psoriatic arthritis (PsA) and are starting either STELARA or a new TNFi as a new therapy in a first, second, or third line of biologic disease-modifying antirheumatic drug (bDMARD) therapy. Approximately 1,400 participants will be enrolled into this study, with 700 participants who are receiving STELARA at study entry and 700 participants who are receiving a new TNFi therapy at study entry. Recruitment into the study will continue for approximately 2 years (with the possibility to extend this period if the patient enrollment target is not reached), with a 3-year follow-up period. For each participant, the follow-up period will continue for 3 years (36 months) after inclusion into the study. Participants will primarily be assessed for parameters of treatment retention, clinical response, effectiveness and safety over an observational period of 36 months.

Arms & Interventions

Arms

: Cohort 1: Ustekinumab Treatment

Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.

: Cohort 2: TNFi Treatment

Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.

Interventions

Drug: - No Intervention

Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab or a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy will be observed.

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

Reumaclinic Genk-Hasselt, Genk, Belgium

Status

Recruiting

Address

Reumaclinic Genk-Hasselt

Genk, , 3600

Site Contact

Clinical Trial Finder