Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-05 @ 12:38 AM
Study NCT ID:
NCT01240850
Status:
UNKNOWN
Last Update Posted:
2010-11-15
First Post:
2010-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012185', 'term': 'Retroperitoneal Fibrosis'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-12', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate by the end of treatment'}], 'secondaryOutcomes': [{'measure': 'Reduction in size of the retroperitoneal mass on CT/MRI scans'}, {'measure': 'Rate of post-treatment relapses'}, {'measure': 'Treatment-related toxicity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retroperitoneal fibrosis', 'Inflammatory aneurysms', 'Methotrexate', 'Prednisone', 'Aorta'], 'conditions': ['Idiopathic Retroperitoneal Fibrosis', 'Perianeurysmal Retroperitoneal Fibrosis', 'Chronic Periaortitis']}, 'referencesModule': {'references': [{'pmid': '17472843', 'type': 'BACKGROUND', 'citation': 'van Bommel EF, Siemes C, Hak LE, van der Veer SJ, Hendriksz TR. Long-term renal and patient outcome in idiopathic retroperitoneal fibrosis treated with prednisone. Am J Kidney Dis. 2007 May;49(5):615-25. doi: 10.1053/j.ajkd.2007.02.268.'}, {'pmid': '18037118', 'type': 'BACKGROUND', 'citation': 'Vaglio A, Palmisano A, Corradi D, Salvarani C, Buzio C. Retroperitoneal fibrosis: evolving concepts. Rheum Dis Clin North Am. 2007 Nov;33(4):803-17, vi-vii. doi: 10.1016/j.rdc.2007.07.013.'}, {'pmid': '16427494', 'type': 'BACKGROUND', 'citation': 'Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.'}, {'pmid': '15897305', 'type': 'BACKGROUND', 'citation': 'Warnatz K, Keskin AG, Uhl M, Scholz C, Katzenwadel A, Vaith P, Peter HH, Walker UA. Immunosuppressive treatment of chronic periaortitis: a retrospective study of 20 patients with chronic periaortitis and a review of the literature. Ann Rheum Dis. 2005 Jun;64(6):828-33. doi: 10.1136/ard.2004.029793.'}, {'pmid': '40974866', 'type': 'DERIVED', 'citation': 'Peyronel F, Palmisano A, Maritati F, Alberici F, Urban ML, Gianfreda D, Rossi GM, Fenaroli P, Bettiol A, Moroni G, Vaglio A. Methotrexate and low-dose prednisone in idiopathic retroperitoneal fibrosis: a randomised clinical trial. J Autoimmun. 2025 Dec;157:103487. doi: 10.1016/j.jaut.2025.103487. Epub 2025 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is generally based on the use of glucocorticoids, which are often effective. However, prolonged steroid treatments are usually needed to achieve a sustained remission; additionally, patients frequently develop disease relapses following treatment discontinuation, therefore they may be exposed to high cumulative doses of glucocorticoids.\n\nPreliminary data reported in the literature show that methotrexate may be effective in combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often used as a steroid-sparing agent in different inflammatory diseases.\n\nThe aim of this study is to evaluate whether a treatment with low-dose prednisone plus methotrexate is non-inferior to conventional dose-prednisone in achieving remission in retroperitoneal fibrosis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent\n\nExclusion Criteria:\n\n* Secondary forms of retroperitoneal fibrosis (e.g. drugs, surgery, neoplasms, infections)\n* Previous medical therapy for retroperitoneal fibrosis\n* Renal failure with creatinine \\>2 mg/dl which proved not to be reversible after ureteral decompression\n* Hypersensitivity to the study drugs\n* Pregnancy\n* Active infections or malignant neoplasms'}, 'identificationModule': {'nctId': 'NCT01240850', 'acronym': 'FIPREDEX', 'briefTitle': 'Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate', 'orgStudyIdInfo': {'id': 'FARM79BKPY'}, 'secondaryIdInfos': [{'id': '2008-007353-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisone', 'interventionNames': ['Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Methotrexate+Prednisone', 'interventionNames': ['Drug: Methotrexate+Prednisone']}], 'interventions': [{'name': 'Methotrexate+Prednisone', 'type': 'DRUG', 'description': 'Methotrexate will be added at a dose of 0.3 mg/kg/week (maximum dose, 20 mg/week, orally) to a reduced-dose prednisone regimen', 'armGroupLabels': ['Methotrexate+Prednisone']}, {'name': 'Prednisone', 'type': 'DRUG', 'armGroupLabels': ['Prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43126', 'city': 'Parma', 'state': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Augusto Vaglio, MD PhD', 'role': 'CONTACT', 'email': 'augusto.vaglio@virgilio.it', 'phone': '+39 0521 702345'}, {'name': 'Augusto Vaglio, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nephrology Unit, University Hospital of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'centralContacts': [{'name': 'Carlo Buzio, MD', 'role': 'CONTACT', 'email': 'carlo.buzio@unipr.it', 'phone': '+39 0521 702345'}, {'name': 'Augusto Vaglio, MD, PhD', 'role': 'CONTACT', 'email': 'augusto.vaglio@virgilio.it', 'phone': '+39 0521 702345'}], 'overallOfficials': [{'name': 'Augusto Vaglio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parma University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Carlo Buzio', 'oldOrganization': 'University of Parma'}}}}