Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:39 PM
Study NCT ID:
NCT07398651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apremilast and Adalimumab in Psoriatic Arthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000068879', 'term': 'Adalimumab'}, {'id': 'C505730', 'term': 'apremilast'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Activity Index for Psoriatic Arthritis', 'timeFrame': '3 months', 'description': 'Assessment of disease activity in psoriatic arthritis patients by Disease Activity Index for Psoriatic Arthritis'}], 'secondaryOutcomes': [{'measure': 'Health assessment questionnaire disability index', 'timeFrame': '3 months', 'description': 'Functional assessment Using health assessment questionnaire disability index'}, {'measure': 'Psoriasis Area and Severity Index', 'timeFrame': '3 months', 'description': 'Psoriasis Area and Severity Index (PASI) for skin involvement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis Patients:', 'Apremilast', 'Adalimumab'], 'conditions': ['Psoriatic Arthritis', 'Ultrasound Assessment', 'TNF']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to compare the efficacy of Apremilast combined with Methotrexate versus Adalimumab combined with Methotrexate', 'detailedDescription': 'Psoriatic arthritis is a heterogeneous chronic systemic auto-immune disease, with variable musculoskeletal involvement as well as skin and nail disease . Up to 30% of patients with psoriasis may develop Psoriatic arthritis over the course of their lifetime. Musculoskeletal manifestations of Psoriatic arthritis include peripheral arthritis, spondylitis, dactylitis and enthesitis.\n\nThe pathogenesis of Psoriatic arthritis is still unclear, due to the heterogeneity of the pathogenic pathways involved, the variable clinical manifestations, and different responses to treatment.\n\nA predisposing genetic background in the presence of environmental factors, such as infections, microbiota (dysbiosis), obesity, biomechanical stress could activate the immune system and precipitate the onset of the disease.\n\nObjectives:\n\n* Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.\n* Assessment of the effect of the studied drugs on functional status of PsA patients.\n* Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients\n\nObjectives:\n\n* Assessment of the effect of the studied drugs on the disease activity clinically and laboratory in PsA patients.\n* Assessment of the effect of the studied drugs on functional status of PsA patients.\n* Evaluation of the effect of the studied drugs on the musculoskeletal ultrasound findings of PsA patients\n\nMusculoskeletal ultrasound is considered one of the most important tools in studying the effects of rheumatic diseases on musculoskeletal structures.\n\nIt is demonstrated that ultrasound is more sensitive than conventional radiography and clinical examination for the assessment of inflammatory and structural changes in inflammatory arthritis, including Psoriatic arthritis, and particularly synovitis, enthesitis, tenosynovitis, and bursitis.\n\nThe treatment of Psoriatic arthritis requires attention to the active domains present in each patient. If the major active domain is peripheral arthritis, treatment usually begins with non-steroidal anti-inflammatory drugs to control symptoms of pain and mild inflammation. If these drugs fail to control disease activity, a conventional synthetic DMARDs is usually prescribed, most commonly methotrexate. Leflunomide and sulfasalazine have also been used in the management of peripheral joint disease. The European Alliance of Associations for Rheumatology guidelines on the management of Psoriatic arthritis with drug therapies suggest that if patients do not attain a satisfactory response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study will include 60 adult Psoriatic arthritis patients \\>18 years old, fulfilling the (CASPAR) classification criteria of Psoriatic arthritis and have an inadequate response to methotrexate therapy for at least 3 months.\n\n * Psoriatic arthritis patients with peripheral musculoskeletal domains (peripheral arthritis, dactylitis and enthesitis) as well as skin and nail domains\n\nExclusion Criteria:\n\n* Patients who received previous biologic agents or Janus kinase inhibitors.\n* Patients with axial and ocular involvement.\n* Current or recent serious infection including tuberculosis or hepatitis B/C .\n* Current or past history of malignancy (within five year).\n* Pregnant or breastfeeding women or women planning pregnancy during the study period .\n* Severe uncontrolled comorbidities such as heart failure, severe liver disease, or chronic kidney disease (eGFR \\<30 mL/min/1.73m²) .'}, 'identificationModule': {'nctId': 'NCT07398651', 'briefTitle': 'Apremilast and Adalimumab in Psoriatic Arthritis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Apremilast and Adalimumab in Psoriatic Arthritis Patients', 'orgStudyIdInfo': {'id': '36265MD4108/12 / 25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'consists of 30 PsA patients who will receive Adalimumab with methotrexate therapy for 3 months.', 'interventionNames': ['Drug: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'consists of 30 PsA patients who will receive Apremilast with methotrexate therapy for 3 months.', 'interventionNames': ['Drug: Apremilast']}], 'interventions': [{'name': 'Adalimumab', 'type': 'DRUG', 'description': 'PsA patients who will receive Adalimumab with methotrexate therapy for 3 months', 'armGroupLabels': ['Group I']}, {'name': 'Apremilast', 'type': 'DRUG', 'description': 'PsA patients who will receive Apremilast with methotrexate therapy for 3 months', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'contacts': [{'name': 'MennaAllah Elmalla, Assistant lecturer', 'role': 'CONTACT', 'email': 'mennaallah.mohamed@med.tanta.edu.eg', 'phone': '+20 10 94422540'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'MennaAllah Elmalla, Assistant lecturer', 'role': 'CONTACT', 'email': 'mennaallah.mohamed@med.tanta.edu.eg', 'phone': '+20 10 94422540'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'All data ill be available if it needed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Rheumatology, Rehabilitation & Physical Medicine', 'investigatorFullName': 'MenaaAllah Mohamed Elmalla', 'investigatorAffiliation': 'Tanta University'}}}}