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Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

Primary Purpose

Psoriatic Arthritis

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Guselkumab
Golimumab
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Psoriatic arthritis meeting CASPAR criteria; Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints (this captures the majority of patients switching therapy in our cohort); At least one active psoriasis plaque; Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy; If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Only use of a single OSM/csDMARD is allowed. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks and remain on a stable dose during the study; age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA). Exclusion Criteria: Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); An adverse event the precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi; Use of moderate to high dose glucocorticoids (>10 mg). Already meet the primary outcome at screening or baseline

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

GOL (4 Weeks)

GUS (8 Weeks)

GUS (4 Weeks)

Arm Description

Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks

Guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks

GUS 100 mg every 4 weeks

Outcomes

Primary Outcome Measures

cDAPSA
Disease Activity in Psoriatic Arthritis: a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity.
IGA Psoriasis
Investigator global assessment (IGA) of psoriasis

Secondary Outcome Measures

PSAID-12
Psoriatic Arthritis Impact of Disease Questionnaire

Full Information

First Posted
November 18, 2022
Last Updated
November 18, 2022
Sponsor
University of Pennsylvania
Collaborators
Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05631457
Brief Title
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)
Official Title
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial is a double-blinded randomized study with three arms: Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks, guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks, and GUS 100 mg every 4 weeks. It will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi
Detailed Description
The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i), is more effective than switching to another TNFi. The proposed trial will test two important management questions. The recommended first biologic therapy for PsA is typically a TNFi, concordant with the ACR/NPF treatment guidelines, but it remains unknown whether, after inadequate response to a first TNFi (TNF IR), switching to a new MOA or a second TNFi is more effective in PsA.5, 9 We hypothesize that switching to a new MOA is more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in the clinical practice setting among patients who are TNF IR. GUS was approved by the FDA in July 2020 for active PsA and, as with other new to market therapies, is currently used primarily in patients who have failed prior biologics. However, the two pivotal RCTs enrolled mostly biologic naïve patients.10, 11 Furthermore, in a European study, patients who had failed a TNFi had a lower response to GUS q8 weeks than those who were TNF naïve. We hypothesize that patients who are TNF IR may need more frequent dosing of the drug. The proposed randomized trial will employ a trial design that is novel to PsA in three ways: 1) We will use a composite measure as the primary outcome that was specifically designed for PsA (supported by evidence from our preliminary data); 2) We will apply a pragmatic approach to assessing therapy effectiveness by recruiting a patient population that is representative of patients seen in clinical practice and enrolling patients at the time of the switch rather than requiring a washout (as drugs are prescribed in clinical practice); 3) We will utilize remote monitoring of intermediate outcomes, reducing the number of visits over the course of one year. The proposed trial addresses important knowledge gaps in the management of PsA, trial designs in PsA, and builds on a longitudinal cohort study to define outcome measures for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
psoriatic arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind randomized controlled trial comparing three active treatment arms.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GOL (4 Weeks)
Arm Type
Active Comparator
Arm Description
Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks
Arm Title
GUS (8 Weeks)
Arm Type
Active Comparator
Arm Description
Guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks
Arm Title
GUS (4 Weeks)
Arm Type
Experimental
Arm Description
GUS 100 mg every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
Tremfya
Intervention Description
Three interventions will be tested: Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks (a TNFi at the approved dose for active PsA), guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks (dose approved for moderate-to-severe plaque psoriasis and active PsA; a placebo injection will be given on the 'off' month), and GUS 100 mg every 4 weeks (dose tested in DISCOVER 1 and 2 but not currently FDA approved).
Intervention Type
Drug
Intervention Name(s)
Golimumab
Other Intervention Name(s)
Simponi
Intervention Description
Three interventions will be tested: Golimumab (GOL) 50 mg subcutaneous injection every 4 weeks (a TNFi at the approved dose for active PsA), guselkumab (GUS) 100 mg subcutaneous injection every 8 weeks (dose approved for moderate-to-severe plaque psoriasis and active PsA; a placebo injection will be given on the 'off' month), and GUS 100 mg every 4 weeks (dose tested in DISCOVER 1 and 2 but not currently FDA approved).
Primary Outcome Measure Information:
Title
cDAPSA
Description
Disease Activity in Psoriatic Arthritis: a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity.
Time Frame
12 Months
Title
IGA Psoriasis
Description
Investigator global assessment (IGA) of psoriasis
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
PSAID-12
Description
Psoriatic Arthritis Impact of Disease Questionnaire
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Psoriatic arthritis meeting CASPAR criteria; Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1 swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints (this captures the majority of patients switching therapy in our cohort); At least one active psoriasis plaque; Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy; If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Only use of a single OSM/csDMARD is allowed. If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks and remain on a stable dose during the study; age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA). Exclusion Criteria: Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); An adverse event the precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi; Use of moderate to high dose glucocorticoids (>10 mg). Already meet the primary outcome at screening or baseline
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Bush
Phone
215-665-6332
Email
katbu@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Email
SpAProgram@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Bush
Email
katbu@upenn.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
SpAProgram@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients (EVOLUTION)

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