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

Psoriatic Arthritis Clinical Trial

Official title:

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05631457
• Other study ID #: 851448
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2023
• Est. completion date: May 2025

Study information

• Verified date: December 2022
• Source: University of Pennsylvania
• Contact: Kathleen Bush
• Phone: 215-665-6332
• Email: katbu[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial is a double-blinded randomized study that 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.

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. Switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in the clinical practice setting among patients who are TNF IR.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Psoriatic arthritis meeting CASPAR criteria;

2. 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

3. At least one active psoriasis plaque;

4. 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;

5. 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.

6. 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;

7. age 18-80

Exclusion Criteria:

1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i);

2. An adverse event that 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;

3. Use of moderate to high dose glucocorticoids (>10 mg).

4. Already meet the primary outcome at screening or baseline

5. Currently pregnant or actively trying to conceive

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Guselkumab Prefilled Syringe [Tremfya]
Guselkumab (GUS) and placebo
• Golimumab
Golimumab (GOL) 50 and placebo

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cDAPSA	Clinical 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. Scale from 0-154 where higher figures indicate worse status. Remission is considered =4 and low disease activity >4 to =13	12 Months
Primary	IGA Psoriasis	Investigator global assessment (IGA) of psoriasis. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe)	12 Months
Secondary	PSAID-12	Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status	6 and 12 months
Secondary	HAQ-DI	THE HEALTH ASSESSMENT QUESTIONNAIRE (HAQ) DISABILITY INDEX (DI). Calculated score of 0-3 where higher figures indicate worse status	6 and 12 months
Secondary	DLQI	Dermatology Life Quality Index (DLQI). Calculated score of 0-30 where higher figures indicate worse status	6 and 12 months