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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

Study Purpose

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.

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:

- 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 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.

 NCT03336281
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 Cilag S.A.S.
Principal Investigator

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

 Janssen Cilag S.A.S., France Clinical Trial
Principal Investigator Affiliation Janssen Cilag S.A.S.
Agency Class

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

 Industry
Overall Status Recruiting
Countries France
Conditions

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

 Psoriatic Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants with Psoriatic Arthritis: Dermatologist Cohort

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.

: Participants with Psoriatic Arthritis: Rheumatologist Cohort

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.

Interventions

Drug: - Ustekinumab

All participants will receive ustekinumab at study entry. Ustekinumab will not be provided by the sponsor. The treatment decision must have been taken by the investigator prior to, and independently of the participant's inclusion into the study following the standard clinical practice. Only data available from a participant's source medical records will be collected.

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

Hôpital Edouard Herriot, Lyon Cedex 03, France

Status

Recruiting

Address

Hôpital Edouard Herriot

Lyon Cedex 03, , 69437

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