Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT07111494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
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': 'D000097789', 'term': 'Glucagon-Like Peptide-1 Receptor Agonists'}], 'ancestors': [{'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-01', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling', 'timeFrame': 'Week 12 and 24', 'description': 'In order to meet Minimal Disease Activity (MDA) participants need to meet 5 of the 7 criteria: tender joint count less than or equal to 68 and greater than or equal to 1 (TJC68), swollen joint count less than or equal to 66 and greater than or equal to 1 (SJC66), psoriasis body surface area is less than or equal to 3%, patient pain Visual Analogue Scale (VAS) is less than or equal to 15mm, patient global disease activity VAS is less than or equal to 20mm, Health Assessment Questionnaire (HAQ) is less than or equal to 0.5 and tender entheseal points is less than or equal to 1. One of the outcomes of this study is to see how these scores change with the participants receiving a GLP-1 or nutrition counseling.'}, {'measure': 'Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24', 'timeFrame': 'Week 12 and 24', 'description': 'DASPA is a composite measure based on the summation of four variables: tender and swollen joints (TJC68, SJC66), C-reactive protein (CRP), Patient Global Assessment (PtGA) and Patient Pain both reported on a 0-100 mm VAS. DASPA classifications validated for PsA include Less than or equal to 4 (remission), greater than 4 but less than or equal to 14 is low disease activity. Greater than 14 but less than or equal to 28 is moderate disease activity and greater than 28 is high disease activity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis', 'GLP-1', 'Minimal Disease Activity', 'Nutrition Counseling'], 'conditions': ['Psoriatic Arthritis (PsA)']}, 'descriptionModule': {'briefSummary': 'Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.\n\nThe main objectives it aims to answer are:\n\nTo assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling.\n\nTo assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling.\n\nParticipants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age 18 and older) who present to rheumatology clinic\n* Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).\n* Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA\n* Participants must have a Body Mass Index (BMI) of 30kg/m\\^2\n* Participants must be treated for PsA in accordance with guidelines\n* Have not achieved MDA in PsA patients\n* Have a minimum TJC \\> 1 and SJC \\> at baseline\n* Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.\n\nExclusion Criteria:\n\n* Any prior use of GLP-1 agonists\n* Inability to provide informed consent\n* Current participation in another PsA study\n* Treatment initiation by GLP-1 agonists contraindicated by FDA\n* Patients with hemoglobin A1c (HbA1c) \\> 10 at baseline'}, 'identificationModule': {'nctId': 'NCT07111494', 'briefTitle': 'Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PRO55130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1', 'interventionNames': ['Drug: GLP-1 agonists']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition Counseling', 'interventionNames': ['Other: Nutrition Counseling']}], 'interventions': [{'name': 'GLP-1 agonists', 'type': 'DRUG', 'description': 'GLP-1, any assigned drug', 'armGroupLabels': ['GLP-1']}, {'name': 'Nutrition Counseling', 'type': 'OTHER', 'description': 'Nutrition Counseling in PsA', 'armGroupLabels': ['Nutrition Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Shikha Singla, MD', 'role': 'CONTACT', 'email': 'ssingla@mcw.edu', 'phone': '414-955-7040'}, {'name': 'Kiley Timler', 'role': 'CONTACT', 'email': 'ktimler@mcw.edu'}, {'name': 'Shikha Singla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Gazeley, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Putman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lisa Morseli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ann Rosenthal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anam Qureshi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical College of Wisconsin/Froedtert Hosptial', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data sharing at National/international conferences'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shikha Singla', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}