A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

Arthritis, Psoriatic Clinical Trial

— PsABIOnd  

Official title:

Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049798
• Other study ID #: CR108938
• Secondary ID: CNTO1959PSA4001
• Status: Recruiting
• Start date: August 25, 2021
• Est. completion date: December 7, 2027

Study information

• Verified date: April 2024
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

Description:

Psoriatic arthritis (PsA) is a seronegative inflammatory spondylarthritis associated with psoriasis (PsO), which can cause pain and swelling in the joints, sausage-shaped swelling of the fingers and toes (dactylitis), inflammation of the muscle- or tendon insertions at adjacent bone (enthesitis), as well as raised red patches or various other expressions of psoriasis on the skin. Guselkumab (TREMFYA) is a fully human immunoglobulin G1 lambda (IgG1) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL) 23 with high specificity and affinity, blocking IL-23 binding. Binding of guselkumab to the IL-23p19 subunit blocks the subsequent binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine production. Participants with confirmed diagnosis of PsA who are starting guselkumab or any marketed interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of PsA biologic therapy per standard clinical practice will be enrolled in the main study. The aim of main study is to document the use of guselkumab and approved IL-17i therapies in routine clinical practice in patients with PsA who are starting guselkumab or an IL-17i as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy. The overall duration of the main study, including recruitment and follow-up, is expected to be about 6 years. Participants who are starting guselkumab or an IL-17i treatment per routine clinical practice in the main study, and who meet the selection criteria for both the main study and substudy, will be consecutively offered entry into the substudy (a select number) at the time of enrollment into the main study. The substudy aims to collect additional data, continuously or with increased frequency, on the impact of guselkumab or IL-17i on patient mood, physical activity, sleep disturbance, disease symptoms, and health-related quality-of-life (HRQoL). Total duration of the substudy will be approximately 26-30 weeks consisting of a pre-treatment period of up to 14 days before the first dose of guselkumab or IL-17i in the main study and a 24-week (plus [+] up to 4 weeks follow-up) observation period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1330
• Est. completion date: December 7, 2027
• Est. primary completion date: December 1, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Main study:

• Have a confirmed diagnosis of PsA as determined by a rheumatologist with reference to Classification criteria for Psoriatic Arthritis (CASPAR)
• Start guselkumab or any approved interleukin-17 inhibitor (IL-17i) as a first, second, third, or fourth line of biologic disease-modifying antirheumatic drugs (bDMARD) therapy for the indication of PsA as part of standard clinical practice (according to local label, local regulations, and/or reimbursement requirements) at the time of enrollment into the observational study or within a maximum of 2 months after the initial baseline visit or after repeated baseline data collection
• Sign a participation agreement/Informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
• Able to read, understand, and intend to comply with completion of all Electronic patient-reported outcome (ePRO) instruments
• The treatment decision must be taken by the participating rheumatologist prior to, and independently of the participant's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations

Substudy:

• Must sign the substudy ICF allowing data collection in accordance with local requirements
• Is scheduled to receive guselkumab or IL-17i, per routine clinical practice, in the main study
• Currently using or is willing to use wearables and/or commercial applications to track their disease within the course of their normal daily activities Exclusion Criteria:

Main study:

• Start guselkumab or an IL-17i therapy as fifth or further line of biologic treatment
• Have already taken a specific IL-17i or IL-23i treatment and are planning on re-taking that specific treatment again
• Unwilling or unable to participate in long-term data collection
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study (that is, signing of informed consent)
• Currently enrolled in any interventional study or any Janssen-sponsored observational clinical study (contemporary participation into observational studies or registries not sponsored by Janssen is acceptable)

Substudy:

• Have an insufficient command of language to interact effectively with the smartphone application, in the opinion of the investigator at each site
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the well-being) or that could prevent, limit, or confound assessment
• Unwilling or unable to comply with substudy assessments

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Guselkumab
Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with guselkumab, will be observed according to standard clinical practice.
• IL-17i
Participants will not receive any intervention as a part of this study. Participants who are initiating the treatment with IL-17i, will be observed according to standard clinical practice.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital J. M. Ramos Mejía	Buenos Aires
Argentina	OMI	Ciudad Autónoma de Buenos Aires
Argentina	Hospital Cordoba	Córdoba
Argentina	MR Medicina Reumatologica	San Fernando Buenos Aires
Australia	The Queen Elizabeth Hospital	Adelaide
Australia	Footscray Hospital, Western Health	Footscray
Australia	Royal North Shore Hospital	St Leonards
Austria	LKH-Univ. Klinikum Graz	Graz
Austria	Kepler Universitätsklinikum GmbH	Linz
Austria	Medizinische Universitat Wien	Vienna
Austria	Evang. Krankenhaus Gemein. Betriebgesm. Mbh	Wien
Belgium	AZ Sint-Jan	Brugge
Belgium	Hopital Erasme	Brussel
Belgium	Reumaclinic Genk-Hasselt	Genk
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège - Domaine Universitaire du Sart Tilman	Liège
Canada	Private Practice - Dr. Pauline Boulos	Dundas	Ontario
Canada	Markham Rheumatology Hub	Markham	Ontario
Canada	Brandusa Florica Medicine Professional Corporation	Mississauga	Ontario
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	The Waterside Clinic	Orillia	Ontario
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.	Quebec
Canada	Centre de sante et services sociaux (CSSS) de Rimouski-Neigette - Hopital regional - Rimouski	Rimouski	Quebec
Canada	Community Rheumatology Care	Saskatoon	Saskatchewan
Canada	Rheumatology Associates of Saskatoon	Saskatoon	Saskatchewan
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Riverside Professional Center	Sydney	Nova Scotia
Canada	Centre de Recherche Musculo Squelettique	Trois Rivieres	Quebec
Canada	Artus Health Centre	Vancouver	British Columbia
Canada	Dr. Sabeen Anwar Medicine Professional Corporation	Windsor	Ontario
Canada	Manitoba Clinic	Winnipeg	Manitoba
Colombia	BIOMAB	Bogota
Colombia	Servimed S A S	Bucaramanga
Colombia	Clinisalud del Sur	Medellin
Colombia	Funcentra	Montería
France	Hôpital Avicenne	Bobigny
France	Centre Hospitalier de Cholet	Cholet
France	Hôpital Gabriel Montpied	Clermont Ferrand
France	Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor	Creteil
France	CHU Grenoble	Echirolles
France	CHRU HOPITAL ROGER SALENGRO Consultation Appareil locomoteur	Lille
France	Centre Orthopedique Santy	Lyon
France	Clinique de l'Infirmerie Protestante de Lyon	Lyon
France	Hôpital Saint Roch	Nice
France	CHR Orléans - Nouvel Hôpital Orléans La Source	Orléans
France	Hôpital Bichat	Paris
France	Hôpital Lariboisière - Centre Viggo Petersen	Paris
France	Hôpital Pitié-Salpétrière	Paris
France	Hopital Saint-Antoine	Paris
France	CHRU Hôpital de Hautepierre	Strasbourg Cedex
France	Hopital Purpan	Toulouse
Germany	Praxis für Rheumatologie	Amberg
Germany	Rheuma-Praxis Bayreuth	Bayreuth
Germany	Rheumatologische Schwerpunktpraxis	Berlin
Germany	Rheumatologische Schwerpunktpraxis	Berlin
Germany	Universitätsklinikum Düsseldorf	Dusseldorf
Germany	Service Rheuma Erfurt	Erfurt
Germany	Universitatsklinikum Frankfurt	Frankfurt
Germany	Rheumapraxis Dr. Liebhaber	Halle-Saale
Germany	Praxis fur Klinische Studien und Praxis fur Orthopadie	Hamburg
Germany	Rheumatologie im Struenseehaus	Hamburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Krankenhaus Porz am Rhein	Koln
Germany	Rheumatologische Praxis	Leipzig
Germany	Rheumatologische Praxis	Magdeburg
Germany	Praxiszentrum St. Bonifatius	München
Germany	Praxis Thilo Klopsch	Neubrandenburg
Germany	Knappschaftsklinikum Saar GmbH Klinik für Rheumatologie	Püttlingen
Germany	Rheumazentrum Ratingen	Ratingen
Germany	Rheumatologisch-immunologische Arztpraxis	Templin
Germany	Immunologisches Zentrum Vogelsang-Gommern GmbH	Vogelsang-Gommern
Greece	Athens Navy Hospital	Athens
Greece	Evangelismos General Hospital of Athens	Athens
Greece	General Hospital 'Gennimatas'	Athens
Greece	Hippokration General Hospital of Athens, B' Internal Medicine Clinic,	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	University Hospital of Ioannina	Ioannina
Greece	'Agios Andreas' General Hospital of Patras	Patra
Greece	University General Hospital of Rio Patras	Patras
Greece	Ippokrateio Hospital	Thessaloniki
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari
Italy	Ospedale Regionale Cardarelli-Università degli Studi del Mol	Campobasso
Italy	Universita della Magna grecia	Catanzaro
Italy	AOU Careggi	Firenze
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Seconda Univesità degli Studi di Napoli, AOU	Napoli
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale	Potenza
Italy	Universita Cattolica del Sacro Cuore	Rome
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino
Italy	Azienda Ospedaliero Universitaria S.Maria Della Misericordia	Udine
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Japan	Kita-harima Medical Center	Hyogo
Japan	Toho University Medical Center, Ohashi Hospital	Meguro-ku
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital	Osaka
Japan	Hokkaido University Hospital	Sapporo
Japan	Kyorin University Hospital	Tokyo
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Medical Care & Research SA de CV	Merida
Mexico	Consultorio de Reumatologia	Mexico
Mexico	Hospital Puerta de Hierro	Zapopan
Netherlands	Academisch Medisch Centrum Universiteit van Amsterdam	Amsterdam
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Elkerliek Ziekenhuis	Helmond
Russian Federation	SBEU HPE Kemerovo State Medical Academy	Kemerovo
Russian Federation	Bakoulev Scientific Center For Cardiovascular Surgery Rams	Moscow
Russian Federation	FGBU Research Institute of Rheumatology named V.A.Nasonova	Moscow
Russian Federation	City Hospital #3	Tomsk
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp. Punta de Europa	Algeciras / Cadiz
Spain	Hosp. Clinic de Barcelona	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. de Basurto	Bilbao
Spain	Hosp. Reina Sofia	Cordoba
Spain	Complejo hospitalario de Granada	Granada
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. de Getafe	Madrid
Spain	Hosp. Univ. Central de Asturias	Oviedo
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Virgen Del Rocio	Sevilla
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Universitetssjukhuset i Lund	Lund
Sweden	Universitetssjukhuset Orebro	Orebro
Sweden	Akademiskt Specialistcentrum centrum för reumatologi	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	HFR Fribourg - Hôpital Cantonal	Fribourg
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
United Kingdom	NHS Grampian - Aberdeen Royal Infirmary (ARI)	Aberdeen
United Kingdom	Nevill Hall Hospital	Abergavenny
United Kingdom	University Hospital Monklands	Airdrie
United Kingdom	Wolfson Centre Royal United Hospitals	Bath
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Chapel Allerton Hospital	Leeds
United Kingdom	Kings College Hospital	London
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit	Newcastle Upon Tyne
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	Shirley Caldwell	Salford
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Haywood Hospital	Staffordshire
United Kingdom	Stamford and Rutland hospital	Stamford
United Kingdom	Wishaw General	Wishaw

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  Colombia,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Russian Federation,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Start and Stop Date of Guselkumab, as Applicable, For Each Participant	The start and stop date, (first and last administration date, respectively) of guselkumab, as applicable, for each participant will be collected to document treatment persistence.	Up to 39 months
Primary	The Start and Stop Date of Interleukin-17 Inhibitor (IL-17i), as Applicable, For Each Participant	The start and stop date (first and last administration date respectively) of IL-17i, as applicable, for each participant will be collected to document treatment persistence.	Up to 39 months
Secondary	Change from Baseline in 66 and 68 Joint Counts for Swelling and Tenderness, Respectively	Change from baseline in 66 and 68 joint counts for swelling and tenderness, respectively will be reported. Joints assessed include the distal interphalangeal, proximal interphalangeal, and metacarpophalangeal joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and proximal interphalangeal joints of the feet.	Baseline up to 39 months
Secondary	Change from Baseline in Rheumatologist's Global Assessment of Disease Activity-Psoriatic Arthritis (PGA-PsA)	The PGA-PsA will be documented using a Visual Analogue Scale (VAS) that ranges from "no PsA activity" (0 Millimeter [mm]) to "extremely active PsA" (100 mm).	Baseline up to 39 months
Secondary	Change from Baseline in Assessment of Dactylitis	The presence of and total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be documented.	Baseline up to 39 months
Secondary	Change from Baseline in Assessment of Enthesitis using Leeds Enthesitis Index (LEI)	The presence and a score of enthesitis will be documented using the LEI to evaluate the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: the lateral epicondyles (left and right), medial femoral condyles (left and right), and Achilles tendon insertions (left and right).	Baseline up to 39 months
Secondary	Change from Baseline in Nail Involvement	Nail involvement will be documented by recording the total number of nails of the hands and feet (that is, 0 to 20) with psoriatic nail changes.	Baseline up to 39 months
Secondary	Change from Baseline in Body Surface Area (BSA) Psoriasis (PSO) Skin Involvement	The BSA score indicates the surface area of the participant's body effected by psoriasis.	Baseline up to 39 months
Secondary	Change from Baseline in C-reactive Protein (CRP)	Change from baseline in CRP will be reported.	Baseline up to 39 months
Secondary	Change from Baseline in Minimal Disease Activity (MDA)/ Very Low Disease Activity (VLDA)	Change from Baseline in MDA/VLDA will be reported.	Baseline up to 39 months
Secondary	Change from Baseline in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA/DAPSA)	DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS (in centimeters), 66 and 68 joint counts for swelling and tenderness, respectively.	Baseline up to 39 months
Secondary	Response as a Measure of Clinical Improvement in cDAPSA/DAPSA	Response is defined as a clinical improvement in cDAPSA/DAPSA. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS (in centimeters), 66 and 68 joint counts for swelling and tenderness, respectively.	Up to 39 months
Secondary	Start and Stop Dates of All Treatments and the Sequence of Treatment Lines	Start and stop dates of all treatments and the sequence of treatment lines will be reported.	Up to 39 months
Secondary	Percentage of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 39 months
Secondary	BSA PSO Skin Involvement	The BSA score indicates the surface area of the participant's body affected by psoriasis.	Up to 39 months
Secondary	Rheumatic Disease Comorbidity Index	Number of comorbid medical conditions of the study participants for the Rheumatic Disease Comorbidity Index will be reported.	Up to 39 months
Secondary	Change from Baseline in Fibromyalgia Rapid Screening Tool (FiRST)	FiRST will be used to help determine whether participants have chronic widespread pain or fibromyalgia syndrome at entry into the study. The FiRST is a validated questionnaire consisting of a combination of 6 items that can detect chronic widespread pain.	Baseline up to 6 months
Secondary	Change from Baseline in European Quality of Life (EuroQoL) 5-Dimensions 5-Levels Questionnaire (EQ-5D-5L)	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems.	Baseline up to 39 months
Secondary	Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)	The functional status of the participants will be assessed by the HAQ-DI. This 20-question self-administered instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area.	Baseline up to 39 months
Secondary	Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12)	PsAID-12 is a validated, self-administered questionnaire that assesses the impact of PsA on participants' lives. It consists of 12 questions, each answered using a numerical rating scale. Questions related to pain, skin problems, work and/or leisure activities, discomfort, embarrassment and/or shame, social participation, and anger, fear, and uncertainty, and depression are scored from 0 (none) to 10 (extreme), functional capacity and sleep disturbance are scored from 0 (no difficulty) to 10 (extreme difficulty) and coping is scored from 0 (very well) to 10 (very poorly).	Baseline up to 39 months
Secondary	Change from Baseline in Patient Global Disease Activity Visual Analog Scale (VAS) Scores	The Patient Global Disease Activity VAS is a self-administered assessment with scores ranging from "very well" (0 mm) to "very poor" (100 mm) that assesses disease activity over the past week.	Baseline up to 39 months
Secondary	Change from Baseline in Pain VAS Score	The pain VAS is a self-administered assessment of average pain during the past week. The scale ranges from "no pain" (0 mm) to "the worst possible pain" (100 mm).	Baseline up to 39 months
Secondary	Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem) which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, morning stiffness severity.	Baseline up to 39 months
Secondary	Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP)	The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the CRP value.	Baseline up to 39 months
Secondary	Change from Baseline in Dermatology Life Quality Index (DLQI)	The DLQI is a dermatology-specific, validated, 10-question quality of life instrument used to measure the impact of skin disease on the quality of life of an affected person. Each question will address how much the participant's skin problem has affected their life and is scored as: 3 = very much, 2 = a lot, 1 = a little, 0 = not at all, or not relevant.	Baseline up to 39 months
Secondary	Change from Baseline in Patient Acceptable Symptom State (PASS)	The PASS measures the level of symptoms beyond which participants consider themselves well. The PASS addresses the concepts of low disease activity, partial remission in symptoms, and well-being.	Baseline up to 39 months
Secondary	Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI: PsA)	The WPAI: PsA is a validated, self-administered questionnaire that assesses work and activity impairment during the past 7 days. The WPAI: PsA produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI: PsA outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.	Baseline up to 39 months
Secondary	Change from Baseline in Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)	TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness, convenience, and side effects of the medication.	Baseline up to 39 months
Secondary	Number of Participants Switching or Stopping Treatment	Number of Participants switching or stopping treatment (including reasons for discontinuation) will be reported.	Up to 39 months