Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 8:30 PM
Study NCT ID:
NCT05669833
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2022-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588857', 'term': 'guselkumab'}, {'id': 'C529000', 'term': 'golimumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement of cDAPSA low disease activity', 'timeFrame': '12 Months', 'description': '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.'}, {'measure': 'Investigator Global Assessment of Psoriasis of Clear or Almost Clear', 'timeFrame': '12 Months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Minimal Disease Activity (MDA) using PSAID-12', 'timeFrame': '6 and 12 months', 'description': '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.'}, {'measure': 'Minimal Disease Activity (MDA) using HAQ-DI', 'timeFrame': '6 and 12 months', 'description': '(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.'}, {'measure': 'Change in PSAID-12', 'timeFrame': '6 and 12 months', 'description': '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.'}, {'measure': 'PSAID-12 < 4', 'timeFrame': '6 and 12 months', 'description': '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.'}, {'measure': 'Change in DLQI', 'timeFrame': '6 and 12 months', 'description': '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.'}, {'measure': 'IGA Among Patients with BSA > 3% at Baseline', 'timeFrame': '6 and 12 months', 'description': '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).'}, {'measure': 'IGA Among Patients with IGA ≥ 2 at Baseline', 'timeFrame': '6 and 12 months', 'description': '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).'}, {'measure': 'Change in Promis Fatigue', 'timeFrame': '6 and 12 Months', 'description': '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.'}, {'measure': 'Resolution of Dactylitis', 'timeFrame': '6 and 12 Months', 'description': '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.'}, {'measure': 'Resolution of Enthesitis', 'timeFrame': '6 and 12 Months', 'description': '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.'}, {'measure': 'Change in BASDAI', 'timeFrame': '6 and 12 Months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis', 'PsA'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '40102973', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Psoriatic arthritis meeting CASPAR criteria;\n2. Active psoriatic arthritis defined by at least 1 swollen joint;\n3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be \\> 14 in patients without psoriasis.\n4. 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;\n5. 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.\n6. 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;\n7. 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).\n\nExclusion Criteria:\n\n1. 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;\n2. 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;\n3. Use of moderate to high dose glucocorticoids (\\>10 mg);\n4. 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.\n\n In patients without psoriasis, cDAPSA must be \\> 14 to meet eligibility requirements.\n5. Currently pregnant or actively trying to conceive.'}, 'identificationModule': {'nctId': 'NCT05669833', 'acronym': 'EVOLUTION', 'briefTitle': 'Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients: a Pragmatic Trial (EVOLUTION)', 'orgStudyIdInfo': {'id': 'CNTO1959PSA3006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guselkumab 100mg q4w', 'description': 'Guselkumab (GUS) 100mg every 4 weeks', 'interventionNames': ['Drug: Guselkumab']}, {'type': 'EXPERIMENTAL', 'label': 'Guselkumab 100mg q8w', 'description': 'Guselkumab (GUS) 100mg every 8 weeks', 'interventionNames': ['Drug: Guselkumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Golimumab 50mg q4w', 'description': 'Golimumab (GOL) 50mg every 4 weeks', 'interventionNames': ['Drug: Golimumab']}], 'interventions': [{'name': 'Guselkumab', 'type': 'DRUG', 'otherNames': ['Tremfya'], 'description': 'Guselkumab (GUS) subcutaneous injection', 'armGroupLabels': ['Guselkumab 100mg q4w', 'Guselkumab 100mg q8w']}, {'name': 'Golimumab', 'type': 'DRUG', 'otherNames': ['Simponi'], 'description': 'Golimumab (GOL) subcutaneous injection', 'armGroupLabels': ['Golimumab 50mg q4w']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33470', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Howard Busch, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Family Arthritis Center', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33563', 'city': 'Plant City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Gina Prakash, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Healing Rheumatology', 'geoPoint': {'lat': 28.01888, 'lon': -82.11469}}, {'zip': '33569', 'city': 'Riverview', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Shanmugapriya Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southwest Florida Rheumatology', 'geoPoint': {'lat': 27.86614, 'lon': -82.32648}}, {'zip': '30047', 'city': 'Lilburn', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Glenn Parris, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Parris and Associates', 'geoPoint': {'lat': 33.8901, 'lon': -84.14297}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'chelsea.boateng@umassmed.edu', 'phone': '774-455-3528'}, {'name': 'Karen Salomon-Escoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Massachusetts Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'bridget.kramer@unmc.edu'}, {'name': 'Ted Mikuls, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'claudine.davis@nyulangone.org', 'phone': '646-501-7379'}, {'name': 'Soumya Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45242', 'city': 'Blue Ash', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Tara Adhikari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cincy Arthritis', 'geoPoint': {'lat': 39.232, 'lon': -84.37827}}, {'zip': '45694', 'city': 'Wheelersburg', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Rajesh Kataria, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Ohio Rheumatology', 'geoPoint': {'lat': 38.73035, 'lon': -82.85545}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Gillespie, MS', 'role': 'CONTACT', 'email': 'sarah.hopkins@pennmedicine.upenn.edu', 'phone': '215-614-1840'}, {'role': 'CONTACT', 'email': 'spaprogram@pennmedicine.upenn.edu'}, {'name': 'Alexis Ogdie-Beatty, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital at the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38555', 'city': 'Crossville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Sivalingam Kanagasegar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cumberland Rheumatology', 'geoPoint': {'lat': 35.94896, 'lon': -85.0269}}, {'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Dhiman Basu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Heritage Rheumatology and Arthritis Care', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronika Solomon', 'role': 'CONTACT', 'email': 'veronika.s@illumination.health'}, {'name': 'Sanjay Chabra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Arthritis Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'jessica.gonzalez@hsc.utah.edu', 'phone': '801-585-0797'}, {'name': 'Jessica Walsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Sarah Gillespie', 'role': 'CONTACT', 'email': 'sarah.hopkins@pennmedicine.upenn.edu', 'phone': '(215) 614-1840'}, {'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'SpAProgram@pennmedicine.upenn.edu'}], 'overallOfficials': [{'name': 'Alexis Ogdie-Beatty, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}