Clinical trial NCT03336281: 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
Official title: Prospective, Multicenter, Non-interventional Study to Characterize Profile of Patient With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: Janssen Cilag S.A.S.
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of Psoriatic Arthritis (PsA) according to the clinical practice and for which a treatment with ustekinumab is indicated as a first (biological-naïve participants) or a second line (biological-experienced participants) of biological disease-modifying antirheumatic drugs (bDMARD) for PsA / psoriasis (PsO) will be observed depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Swelling of Joints at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With Swelling of Joints at Week 16
timeFrame: Week 16
measure: Number of Participants With Swelling of Joints at Week 28
timeFrame: Week 28
measure: Number of Participants With Tenderness of Joints at Baseline
timeFrame: Baseline (Week 0)
measure: Number of Participants With Tenderness of Joints at Week 16
timeFrame: Week 16
measure: Number of Participants With Tenderness of Joints at Week 28
timeFrame: Week 28
measure: Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good Response at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants Achieving EULAR Good Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving EULAR Good Response at Week 28
timeFrame: Week 28
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants Achieving MDA at Week 16
timeFrame: Week 16
measure: Percentage of Participants Achieving MDA at Week 28
timeFrame: Week 28
measure: Change from Baseline in Physician's Global Assessment of Disease Activity - Psoriatic Arthritis (PGA-PsA) Visual Analogue Scale (VAS) Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PGA-PsA VAS Scores at Week 28
timeFrame: Baseline and Week 28
measure: Change from Baseline in Patient's Global Assessment (PtGA-PsA) VAS Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in PtGA-PsA VAS Scores at Week 28
timeFrame: Baseline and Week 28
measure: Participant's Pain VAS Scores at Baseline
timeFrame: Baseline (Week 0)
measure: Participant's Pain VAS Scores at Week 16
timeFrame: Week 16
measure: Participant's Pain VAS Scores at Week 28
timeFrame: Week 28
measure: Percentage of Participants With Dactylitis at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With Dactylitis at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Dactylitis at Week 28
timeFrame: Week 28
measure: Change from Baseline in Dactylitis Count at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in Dactylitis Count at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of Participants With Dactylitis Complete Resolution at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With Dactylitis Complete Resolution at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Dactylitis Complete Resolution at Week 28
timeFrame: Week 28
measure: Percentage of Participants With Enthesitis at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With Enthesitis at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Enthesitis at Week 28
timeFrame: Week 28
measure: Change from Baseline in Enthesitis Score at Week 16
timeFrame: Baseline and Week 16
measure: Change from Baseline in Enthesitis Score at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of Participants With Enthesitis Complete Resolution at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Enthesitis Complete Resolution at Week 28
timeFrame: Week 28
measure: Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in ESR at Week 28
timeFrame: Baseline and Week 28
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in CRP at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of Participants With Psoriatic Arthritis (PsA) Extra-articular Manifestations at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With PsA Extra-articular Manifestations at Week 16
timeFrame: Week 16
measure: Percentage of Participants With PsA Extra-articular Manifestations at Week 28
timeFrame: Week 28
measure: Percentage of Participants With Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants With BSA PsO Skin Involvement at Week 16
timeFrame: Week 16
measure: Percentage of Participants With BSA PsO Skin Involvement at Week 28
timeFrame: Week 28
measure: Change From Baseline in Nail Involvement Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Nail Involvement Scores at Week 28
timeFrame: Baseline and Week 28
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 28
timeFrame: Baseline and Week 28
measure: Percentage of Participants Achieving HAQ-DI Response at Baseline
timeFrame: Baseline (Week 0)
measure: Percentage of Participants Achieving HAQ-DI Response
timeFrame: Week 16
measure: Percentage of Participants Achieving HAQ-DI Response at Week 28
timeFrame: Week 28
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Questionnaire Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in PsAID-12 Questionnaire Scores at Week 28
timeFrame: Baseline and Week 28
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 28
timeFrame: Baseline and Week 28
measure: Treatment Retention
timeFrame: Time from first ustekinumab administration to drug stop or switch or study withdrawal (approximately up to 28 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon Cedex 03
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Janssen Cilag S.A.S.
name: Janssen Cilag S.A.S., France Clinical Trial
role: STUDY_DIRECTOR
References: