A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab (PROUST)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Psoriatic Arthritis

Treatments: Drug: Ustekinumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03336281

CNTO1275PSO4058 (Other Identifier)

CR108343

Details and patient eligibility

About

The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant with a confirmed diagnosis of Psoriatic Arthritis (PsA) according to the dermatological and/or rheumatologic routine practice, using different diagnosis tools, example, the Classification criteria for Psoriatic Arthritis (CASPAR), or others
• Participant must be starting ustekinumab for PsA according to the local labelling, as a first (biological naïve participant), or second line (biological experienced participants) of bDMARD therapy: First line bDMARD therapy: The first line therapy includes all bio-naïve participants who start their ustekinumab as their first biologic treatment at the study start (within a maximum 1-month window after the baseline visit); Second line bDMARD therapy: The second line therapy includes participants who initiated ustekinumab as their second biologic therapy at the study start (within a maximum 1-month window after the baseline visit)
• Participant for which the ustekinumab treatment has been decided by the investigator prior to and independently of the participant's inclusion into the study
• Participant for which the first administration of the ustekinumab treatment will occur within the 4-week period from inclusion assessment
• Participant has signed an informed consent form

Exclusion criteria

• Participant starting ustekinumab as a third or further line of bDMARD therapy
• Already ustekinumab-experienced participants
• Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within at least 30 days before the start of the study or more according to the half-life of the investigational drug
• Participant has refused to participate in the study or unable to give his consent

Trial design

221 participants in 2 patient groups

Participants with Psoriatic Arthritis: Dermatologist Cohort

Description:

Participants who will receive ustekinumab (as a first or second line of biologic disease modifying anti-rheumatic drug \[bDMARD\] therapy) along with other co-medications as per clinical dematologist's discretion will be observed in this study. Ustekinumab will not be provided by the sponsor. The treatment by ustekinumab must have been decided by the physician prior to the decision to include the participant in the study. Only data available from a participant's source medical records will be collected. Additionally investigators will be asked to obtain (or record where available) Patient-Reported Outcome (PRO) data from participants participating in this study.

Treatment:

Drug: Ustekinumab

Participants with Psoriatic Arthritis: Rheumatologist Cohort

Description:

Participants who will receive ustekinumab (as a first or second line of bDMARD therapy) along with other co-medications as per clinical rheumatologist's discretion will be observed in this study. Ustekinumab will not be provided by the sponsor. The treatment by ustekinumab must have been decided by the physician prior to the decision to include the participant in the study. Only data available from a participant's source medical records will be collected. Additionally investigators will be asked to obtain (or record where available) PRO data from participants participating in this study.

Treatment:

Drug: Ustekinumab