Psoriatic ArthritisPhase 3EVOLUTIONNCT05669833
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
A Phase 3 study testing Guselkumab and Golimumab in people with Psoriatic Arthritis, run by University of Pennsylvania at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Guselkumab and Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 14 sitesUnited States
- Study dates
- 14 Jul 2023to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Psoriatic arthritis meeting CASPAR criteria;
- Active psoriatic arthritis defined by at least 1 swollen joint;
- cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
- 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 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.
- 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;
- 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).
Who cannot join
- 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;
- 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;
- Use of moderate to high dose glucocorticoids (>10 mg);
- 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.
- Currently pregnant or actively trying to conceive.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Cincy Arthritis
Blue Ash, Ohio, 45242
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, 76034
Cumberland Rheumatology
Crossville, Tennessee, 38555
Texas Arthritis Center
El Paso, Texas, 79902
Parris and Associates
Lilburn, Georgia, 30047
Family Arthritis Center
Loxahatchee Groves, Florida, 33470
New York University
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Healing Rheumatology
Plant City, Florida, 33563
Southwest Florida Rheumatology
Riverview, Florida, 33569
University of Utah
Salt Lake City, Utah, 84132
Southern Ohio Rheumatology
Wheelersburg, Ohio, 45694
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Guselkumab, Golimumab
- Keywords
- Psoriatic Arthritis, PsA
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called Tremfya
Guselkumab (GUS) subcutaneous injection
GolimumabDrug
Also called Simponi
Golimumab (GOL) subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab 100mg q4w | Experimental | Guselkumab (GUS) 100mg every 4 weeks Receives: Drug: Guselkumab |
| Guselkumab 100mg q8w | Experimental | Guselkumab (GUS) 100mg every 8 weeks Receives: Drug: Guselkumab |
| Golimumab 50mg q4w | Active comparator | Golimumab (GOL) 50mg every 4 weeks Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
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).
Measured: 12 Months
Secondary outcomes (11)
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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).
Measured: 6 and 12 months
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).
Measured: 6 and 12 months
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.
Measured: 6 and 12 Months
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.
Measured: 6 and 12 Months
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.
Measured: 6 and 12 Months
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.
Measured: 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start14 Jul 2023
- Primary completion26 Oct 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Alexis Ogdie-Beatty, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669833
- Sponsor's protocol ID
- CNTO1959PSA3006
- Acronym
- EVOLUTION
- Status last verified
- Nov 2026
- First submitted
- 20 Dec 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogdie A, Reddy SM, Gillespie SH, Husni ME, Scher JU, Salomon-Escoto K, Kay J, Luedders BA, Curtis JR, Shields AJS, Chakravarty SD, Gong C, Walsh JA. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial. Trials. 2025 Mar 19;26(1):96. doi: 10.1186/s13063-025-08777-y.
PubMed 40102973
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)
- ClinicalTrials.gov ID
- NCT05669833
- Acronym / sponsor ID
- EVOLUTION / CNTO1959PSA3006
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, PsA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 26 Oct 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guselkumab 100mg q4w | Experimental | Drug: GuselkumabGuselkumab (GUS) 100mg every 4 weeks |
| Guselkumab 100mg q8w | Experimental | Drug: GuselkumabGuselkumab (GUS) 100mg every 8 weeks |
| Golimumab 50mg q4w | Active comparator | Drug: GolimumabGolimumab (GOL) 50mg every 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Psoriatic arthritis meeting CASPAR criteria;
- Active psoriatic arthritis defined by at least 1 swollen joint;
- cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be > 14 in patients without psoriasis.
- 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 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.
Key exclusion criteria (6 listed)
- 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;
- 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;
- Use of moderate to high dose glucocorticoids (>10 mg);
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuselkumabAlso: TremfyaGuselkumab (GUS) subcutaneous injection | Drug | Guselkumab 100mg q4w, Guselkumab 100mg q8w |
| GolimumabAlso: SimponiGolimumab (GOL) subcutaneous injection | Drug | Golimumab 50mg q4w |
Primary outcome
Achievement of cDAPSA low disease activity
Time frame: 12 Months
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.
Investigator Global Assessment of Psoriasis of Clear or Almost Clear
Time frame: 12 Months
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).
11 secondary outcomes
Minimal Disease Activity (MDA) using PSAID-12
Time frame: 6 and 12 months
Minimal Disease Activity (MDA) using HAQ-DI
Time frame: 6 and 12 months
Change in PSAID-12
Time frame: 6 and 12 months
PSAID-12 < 4
Time frame: 6 and 12 months
Change in DLQI
Time frame: 6 and 12 months
IGA Among Patients with BSA > 3% at Baseline
Time frame: 6 and 12 months
IGA Among Patients with IGA ≥ 2 at Baseline
Time frame: 6 and 12 months
Change in Promis Fatigue
Time frame: 6 and 12 Months
Resolution of Dactylitis
Time frame: 6 and 12 Months
Resolution of Enthesitis
Time frame: 6 and 12 Months
Change in BASDAI
Time frame: 6 and 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 40102973Ogdie A, Reddy SM, Gillespie SH, Husni ME, Scher JU, Salomon-Escoto K, Kay J, Luedders BA, Curtis JR, Shields AJS, Chakravarty SD, Gong C, Walsh JA. Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial. Trials. 2025 Mar 19;26(1):96. doi: 10.1186/s13063-025-08777-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Ogdie-Beatty, MD, MSCE principal investigator
University of Pennsylvania
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guselkumab and Golimumab in people with Psoriatic Arthritis, run by University of Pennsylvania at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of cDAPSA low disease activity (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.