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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Drug: Golimumab; Drug: Guselkumab Prefilled Syringe [Tremfya]

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. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Coordinator; Email: SpAProgram@pennmedicine.upenn.edu
• Study Contact Backup: Name: Kathleen Bush; Phone Number: 215-665-6332; Email: katbu@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Contact: Study Coordinator; Email: SpAProgram@pennmedicine.upenn.edu
      • Contact: Kathleen Bush; Email: katbu@upenn.edu
      • Principal Investigator: Alexis Ogdie-Beatty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GOL and Placebo; Golimumab (GOL) and placebo	Drug: Golimumab; Golimumab (GOL) 50 and placebo; Other Names: Simponi
Experimental: GUS and placebo (8 Weeks); Guselkumab (GUS) and placebo (8 Weeks)	Drug: Guselkumab Prefilled Syringe [Tremfya]; Guselkumab (GUS) and placebo; Other Names: Tremfya
Experimental: GUS and placebo (4 Weeks); Guselkumab (GUS) and placebo (4 Weeks)	Drug: Guselkumab Prefilled Syringe [Tremfya]; Guselkumab (GUS) and placebo; Other Names: Tremfya

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
DLQI	Dermatology Life Quality Index (DLQI). Calculated score of 0-30 where higher figures indicate worse status	6 and 12 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: psoriatic arthritis
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: 851448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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