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NCT05669833 | RECRUITING | Psoriatic Arthritis

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Sponsor:

University of Pennsylvania

Brief Summary:

The trial is an open-label 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.

Condition or disease

Psoriatic Arthritis

Intervention/treatment

Guselkumab

Golimumab

Phase

PHASE3

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) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that 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 a clinical practice setting among patients who are TNF IR.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
Actual Study Start Date : 2023-07-14
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Psoriatic arthritis meeting CASPAR criteria;
  • 2. Active psoriatic arthritis defined by at least 1 swollen joint;
  • 3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be \> 14 in patients without psoriasis.
  • 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 an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Use of up to two OSM/csDMARDs is allowed.
  • 6. If using NSAIDs, glucocorticoids (\<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to Screening/Baseline 1 and remain on a stable dose during the study;
  • 7. 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
  • 1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); prior exposure to a TYK2i is acceptable, but cannot be used during course of the study;
  • 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 meets the primary endpoint at Baseline; \[cDAPSA low disease activity ≤ 14; IGA of psoriasis 0/1\] In patients with psoriasis, cDAPSA can be 10-14 IF the Investigator Global Assessment of Psoriasis ≥ 2.
  • In patients without psoriasis, cDAPSA must be \> 14 to meet eligibility requirements.
  • 5. Currently pregnant or actively trying to conceive.
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Location Details

NCT05669833

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Family Arthritis Center

Loxahatchee Groves, Florida, United States, 33470

RECRUITING

United States, Florida

Healing Rheumatology

Plant City, Florida, United States, 33563

RECRUITING

United States, Florida

Southwest Florida Rheumatology

Riverview, Florida, United States, 33569

RECRUITING

United States, Georgia

Parris and Associates

Lilburn, Georgia, United States, 30047

RECRUITING

United States, Massachusetts

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

RECRUITING

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

RECRUITING

United States, New York

New York University

New York, New York, United States, 10016

RECRUITING

United States, Ohio

Cincy Arthritis

Blue Ash, Ohio, United States, 45242

RECRUITING

United States, Ohio

Southern Ohio Rheumatology

Wheelersburg, Ohio, United States, 45694

RECRUITING

United States, Pennsylvania

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Tennessee

Cumberland Rheumatology

Crossville, Tennessee, United States, 38555

RECRUITING

United States, Texas

Heritage Rheumatology and Arthritis Care

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

Texas Arthritis Center

El Paso, Texas, United States, 79902

RECRUITING

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84132