Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Psoriatic Arthritis Clinical Trial

— EVOLUTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669833
• Other study ID #: CNTO1959PSA3006
• Status: Recruiting
• Phase: Phase 3
• Start date: July 14, 2023
• Est. completion date: May 2026

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: Sarah Gillespie
• Phone: (215) 614-1840
• Email: sarah.hopkins[@]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) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• 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
Guselkumab (GUS) subcutaneous injection
• Golimumab
Golimumab (GOL) subcutaneous injection
• Placebo
Guselkumab (GUS) matching placebo subcutaneous injection

Locations

Country	Name	City	State
United States	Hospital at the 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	Achievement of cDAPSA low disease activity	Clinical Disease Activity in Psoriatic Arthritis (cDAPSA): 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	Investigator Global Assessment of Psoriasis of Clear or Almost Clear	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	Minimal Disease Activity (MDA) using PSAID-12	Minimal Disease Activity (MDA) defines a satisfactory state of disease activity that includes 5 domains of PsA. 5/7 of the following criteria must be satisfied for MDA: patient global = 2 (0-10), patient pain = 2 (0-10), PSAID-12 <4 (0-10), TJC (Tender Joint Count) = 1, SJC (Swollen Joint Count) = 1, BSA (Body Surface Area) = 3, and Leeds Enthesitis Index = 1.	6 and 12 months
Secondary	Minimal Disease Activity (MDA) using HAQ-DI	(MDA) Minimal Disease Activity defines a satisfactory state of disease activity that includes 5 domains of PsA. Participant would need to achieve 5/7 of the following criteria: patient global = 2 (0-10), patient pain = 2 (0-10), HAQ-DI (Health Assessment Questionnaire Disability Index) < 0.5 (0-3), TJC (Tender Joint Count) = 1, SJC (Swollen Joint Count) = 1, BSA (Body Surface Area) = 3, and Leeds Enthesitis Index = 1.	6 and 12 months
Secondary	Change in 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. Negative changes from baseline indicate improvement in disease activity.	6 and 12 months
Secondary	PSAID-12 < 4	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	Change in DLQI	Dermatology Life Quality Index (DLQI) is a measure of skin disease activity. Calculated score of 0-30 where higher figures indicate worse status.Negative changes from baseline indicate improvement in disease activity.	6 and 12 months
Secondary	IGA Among Patients with BSA > 3% at Baseline	Investigator global assessment (IGA) of psoriasis among patients with BSA (Body Surface Area) >3% at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).	6 and 12 months
Secondary	IGA Among Patients with IGA = 2 at Baseline	Investigator global assessment (IGA) of psoriasis among patients with IGA of 2 or more (= 2) at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).	6 and 12 months
Secondary	Change in Promis Fatigue	Promis Fatigue is a measure of fatigue with a score from 8-40 where higher figures indicate worse status. A negative change indicates less overall fatigue.	6 and 12 Months
Secondary	Resolution of Dactylitis	Dactylitis is assessed using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. These results are summed to produce a final score ranging from 0 to 20. A higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with a baseline dactylitis score >0.	6 and 12 Months
Secondary	Resolution of Enthesitis	Enthesitis is assessed using the Leeds Enthesitis Index (LEI). This measure includes the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The total LEI score of 0-6 is based on evaluating each of these six sites as 0 or 1 based on the absence or presence of pain/tenderness. Resolution of enthesitis is defined as a enthesitis score of 0 with a baseline enthesitis score >0.	6 and 12 Months
Secondary	Change in BASDAI	Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) among patients with axial disease. The BASDAI sum score ranges from 0 to 10 and higher values indicate more active disease. Negative changes from baseline indicate improvement in disease activity.	6 and 12 Months