Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 5:26 AM
Study NCT ID:
NCT06998628
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Disease Activity Score (DAS28)', 'timeFrame': '3 months', 'description': 'Calculation of 28-joint count Disease\n\nActivity Score (DAS28) using C- reactive protein level (CRP) according to the following formula:\n\nDAS28-CRP = \\[0.56\\*√ (tender joint count) + 0.28\\*√ (swollen joint count) + 0.36\\*ln (CRP+1)\\]\n\n\\*1.10 + 1.15\\] will be done where sever disease activity ≥ 5.1, moderate disease activity from 3.2 to 5.1, mild disease activity from 2.6 to 3.2, and remission \\<2.6.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is a long-term inflammatory condition that leads to gradual damage of joints lined by synovial membranes, along with various potential effects outside of the joints. While RA can affect any joint, it typically involves the metacarpophalangeal, proximal interphalangeal, and metatarsophalangeal joints, as well as the wrists and knees. Symptoms related to the joints and surrounding tissues include swelling, tenderness upon touch, morning stiffness, and significant difficulty moving the affected joints'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \\[9\\] i.e., 28 joints disease activity score (DAS 28) \\>2.6.\n* Patients receiving the conventional DMARDs.\n* Both sexes.\n* Age range between 18and 70 years old\n\nExclusion Criteria:\n\n* Patients with retinal or cerebral hemorrhage.\n* Patients with renal and hepatic dysfunction.\n* Patients with hypersensitivity to study medications.\n* Pregnant and lactating females.\n* Patients receiving biological or synthetic DMARDs'}, 'identificationModule': {'nctId': 'NCT06998628', 'briefTitle': 'Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study Evaluating the Effect of Pentoxifylline as Anti Inflammatory in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '78956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'will receive the traditional therapy of RA for three months.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pentoxifylline group', 'description': 'will receive 400 mg pentoxifylline two times daily plus the traditional therapy of RA for three months.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Pentoxifylline']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate (MTX) is a chemotherapy agent and immune-system suppressant. It is used to treat cancer, autoimmune diseases, and ectopic pregnancies. Types of cancers it is used for including breast cancer, leukemia, lung cancer, lymphoma, gestational trophoblastic disease, and osteosarcoma. Methotrexate is also used to treat rheumatoid arthritis and other inflammatory conditions.', 'armGroupLabels': ['Control group', 'Pentoxifylline group']}, {'name': 'Pentoxifylline', 'type': 'DRUG', 'description': 'Pentoxifylline (also known as oxpentifylline) is a methylxanthine derivative with strong hemorrheologic effects. In the United States, it is primarily used to treat intermittent claudication. Studies in both humans and animals have demonstrated that pentoxifylline therapy induces various physiological changes at the cellular level', 'armGroupLabels': ['Pentoxifylline group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34511', 'city': 'Damietta', 'state': 'Damietta Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shrouk Ali, M.Sc', 'role': 'CONTACT', 'email': 'selsies@horus.edu.eg', 'phone': '01009264128'}], 'facility': 'Faculty of Medicine, Al-Azhar University', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Sahar Kamal Hegazy, Professor of Clinical Pharmacy, Faculty of Pharmacy - Tanta University', 'class': 'UNKNOWN'}, {'name': 'Dr. Mustafa Adel Mustafa Elmenawy Lecturer of Rheumatology and Rehabilitation, Faculty of Medicine - El-Azhar University - Damietta', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator', 'investigatorFullName': 'Shrouk Ali Mohamed Elsies', 'investigatorAffiliation': 'Tanta University'}}}}