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

Sponsor

Janssen Pharmaceutica N.V., Belgium (Industry)

Overall Status

Completed

CT.gov ID

NCT02627768

Collaborator

(none)

991

Enrollment

Locations

60.5

Actual Duration (Months)

14.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: No Intervention

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.

Study Design

Study Type:

Observational

Actual Enrollment :

991 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 17, 2015

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1: Ustekinumab Treatment Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.	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.
Cohort 2: TNFi Treatment Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.	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.

Arm

Intervention/Treatment

Cohort 1: Ustekinumab Treatment

Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.

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.

Cohort 2: TNFi Treatment

Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy.

Drug: No Intervention

Outcome Measures

Primary Outcome Measures

Time to Drug Stop or Switch [Up to Month 36]
Time taken to stop or switch the study drug is evaluated.
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Month 36 [Baseline and Month 36]
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0 = no disease activity to 100 = maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 less than or equal to (<=) 3.2 or a change from Baseline less than (<) -1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to <= 5.1 or a change from Baseline < -0.6 to greater than or equal to (>=) -1.2.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Scores at Month 36 [Baseline and Month 36]
The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on visual analog scale (VAS) (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Joints assessed include the distal interphalangeal (DIP), proximal interphalangeal (PIP), and metacarpophalangeal (MCP) joints of the hands; the wrist, elbow, shoulder, acromioclavicular, sternoclavicular, temporomandibular, hip (excluded for swelling), knee, ankle, and midtarsal joints; and the metatarsophalangeal and PIP joints of the feet. CRP level in milligrams per deciliters (mg/dL). Cut-off values for low and high disease activity are <= 14 and > 28 points, respectively, and for remission is <= 4 points.
Percentage of Participants Achieving Low Disease Activity Based on DAPSA Score [Month 36]
The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Cut-off values for low and high disease activity are <= 14 and > 28 points, respectively, and for remission is <= 4 points.
Percentage of Participants Achieving Remission Based on DAPSA Score [Month 36]
The DAPSA score will be calculated by the data collection tool and is the sum of the following: Participant's assessment of pain on VAS (in centimeters), Participant's Global Assessment of Disease Activity on VAS, 66 and 68 joint counts for swelling and tenderness, respectively. Cut-off values for low and high disease activity are <= 14 and > 28 points, respectively, and for remission is <= 4 points.
Change From Baseline in Physician's Global Assessment of Disease Activity (PGA-PsA) Measured on a Visual Analogue Scale at Month 36 [Baseline and Month 36]
Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Change From Baseline in Patient Global Assessment of Disease Activity (PtGA) at Month 36 [Baseline and Month 36]
The PtGA 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. Proposed categories for interpretation of the VAS score: <10 mm, low disease activity; >= 10 millimeter (mm) but <30 mm moderate disease activity; >= 30 mm but <60 mm high disease activity; >= 60 mm very high disease activity.
Percentage of Participants with Dactylitis Over Time [Up to Month 36]
The total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.
Percentage of Participants with Enthesitis Over Time [Up to Month 36]
Enthesitis will be documented using the Leeds Enthesitis Index (LEI). The LEI examination points include the lateral epicondyle (left and right), medial femoral condyle (left and right), and Achilles tendon insertion (left and right).
Change From Baseline in Nail Involvement Scores (Number Of Nails) at Month 36 [Baseline and Month 36]
Nail involvement will be evaluated by recording the total number of nails of the hands and feet (that is, 0 to 20) with PsA involvement.
Change From Baseline in C-Reactive Protein (CRP) at Month 36 [Baseline and Month 36]
C-Reactive Protein will be evaluated to measure the inflammation.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 36 [Baseline and Month 36]
Erythrocyte Sedimentation Rate will be evaluated to measure the inflammation.
Percentage of Participants With Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement [Month 36]
Psoriasis skin involvement will be documented using categories: <3 percentage (%), 3% to 10%, and >10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.
Change From Baseline in Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement at Month 36 [Baseline and Month 36]
Psoriasis skin involvement will be documented using categories: <3%, 3% to 10%, and >10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.
Percentage Change From Baseline in EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3L) Scores at Month 36 [Baseline and Month 36]
The EQ-5D-3L is a standardized measure of health status developed by the EuroQoL Group to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical economic evaluation of health care. The EQ 5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems.
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 36 [Baseline and Month 36]
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Percentage of Participants Achieving in the Health Assessment Questionnaire Disability Index (HAQ-DI) Response [Month 36]
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) at Month 36 [Baseline and Month 36]
The PsAID-12 is a validated, self-administered questionnaire developed by EULAR for use in clinical practice 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) and 10 (extreme difficulty) and coping is scored from 0 (very well) 10 (very poorly).
Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Month 36 [Baseline and Month 36]
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). This assessment should be completed prior to the tender and swollen joint examination.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores at Month 36 [Baseline and Month 36]
The BASDAI participant rated components over last 48 hours using 100 mm Visual Analog Scale; components 15: range 0=none to 100=very severe; component 6: range:0=0 hours to 100=2 hours or more. 1) Overall level of fatigue/tiredness experienced; 2) Overall level of AS neck,back or hip pain experienced; 3) Overall level of pain/swelling in joints other than neck, back or hips; 4) Overall level of discomfort from any areas tender to touch or pressure; 5) Overall level of morning stiffness from time of awakening; 6) Duration of morning stiffness from time of awakening, and morning stiffness sub-scale.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriatic Arthritis (WPAI:PsA) Scores at Month 36 [Baseline and Month 36]
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.
Percentage of Participants With Change in Employment Status [Month 36]
Change in the employment status of participants will be evaluated.

Secondary Outcome Measures

Number of Participants with Adverse Events (AEs) and Serious AEs [Screening up to follow-up (Approximately Month 39)]
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist according to ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria
Must be starting either STELARA or any new approved tumor necrosis factor alpha inhibitor (TNFi) (including TNFi biosimilar) as a new biologic disease-modifying antirheumatic drug (bDMARD) therapy in a first, second or third line of bDMARD therapy for PsA at the time of enrollment into the observational study or within a maximum 2-month window after the baseline visit
Must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

Participant is starting STELARA or a TNFi therapy as fourth or further line of biologic treatment
Participant is unwilling or unable to participate in long-term data collection
Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or the first data collection time point
Participant is currently enrolled in an interventional study

Contacts and Locations

Locations

	City	Country
1	Brussels	Belgium
2	Ceroux-Mousty	Belgium
3	Forest	Belgium
4	Genk	Belgium
5	Gilly	Belgium
6	Hasselt	Belgium
7	Leuven	Belgium
8	Liege	Belgium
9	Merksem	Belgium
10	Besancon	France
11	Bordeaux N/a	France
12	Clermont Ferrand	France
13	Corbeil	France
14	Creteil	France
15	Lille	France
16	Lyon cedex 03	France
17	Lyon	France
18	Marseille	France
19	Montpellier, Herault	France
20	Paris	France
21	Toulouse	France
22	Tours	France
23	Athens	Greece
24	Heraklion	Greece
25	Larissa	Greece
26	Patra	Greece
27	Thessaloniki	Greece
28	Voula Attica	Greece
29	Alkmaar	Netherlands
30	Amsterdam	Netherlands
31	Den Helder	Netherlands
32	Groningen	Netherlands
33	Rotterdam	Netherlands
34	Sneek	Netherlands
35	Utrecht	Netherlands
36	Kemerovo	Russian Federation
37	Khabarovsk	Russian Federation
38	Moscow	Russian Federation
39	Saint-Petersburg	Russian Federation
40	Saransk	Russian Federation
41	St.Petersburg	Russian Federation
42	Stavropol	Russian Federation
43	Barcelona	Spain
44	Bilbao	Spain
45	Getafe	Spain
46	Granada	Spain
47	Madrid	Spain
48	Mérida	Spain
49	Salamanca	Spain
50	San Sebastian	Spain
51	Valladolid	Spain
52	Vitoria	Spain
53	Abergavenny	United Kingdom
54	Bath	United Kingdom
55	Cambridge	United Kingdom
56	Cannock	United Kingdom
57	Christchurch	United Kingdom
58	Glasgow	United Kingdom
59	Leeds	United Kingdom
60	London	United Kingdom
61	Manchester	United Kingdom
62	Reading	United Kingdom
63	Salford	United Kingdom
64	Sheffield	United Kingdom
65	Stoke-on-Trent	United Kingdom
66	Wigan	United Kingdom
67	Wirral	United Kingdom
68	Wolverhampton	United Kingdom