NCT02627768

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

Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 991 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-17
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2015-12-11
• Last updated: 2021-06-21

Locations

66 sites across 7 countries: Belgium, France, Greece, Netherlands, Russia, Spain, United Kingdom