Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-03 @ 8:10 AM
Study NCT ID:
NCT03365869
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-04', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants whose modified Rodnan skin score （mRSS）decreasing', 'timeFrame': 'week 48', 'description': 'mRSS was evaluated in 17 sites of skin.'}], 'secondaryOutcomes': [{'measure': 'The number of adverse event and severe adverse event occured', 'timeFrame': 'week 48', 'description': 'SAE were recorded as life-threatening and others were AE.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis.\n\nThe investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).', 'detailedDescription': 'Each SSc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (SIR 2mg, po., Qd) .\n\nThe end points were the changement of modified RSS and the adverse events or severe adverse events onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the American College of Rheumatology criteria for the diagnosis of SSc, 2013.\n* Disease duration less than 5 years.\n* mRSS was under stable level (\\>1 month) at the time inclusion.\n* Negative urine pregnancy test\n* Written informed consent form\n\nExclusion Criteria:\n\n* Diagnosed with localized scleroderma .\n* Added with immunosuppressor in one month such as MTX, AZA, CYC.\n* Added with anti-fibosis drug in one month.\n* Prednisone \\>10mg QD before inclusion.\n* Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\\> 3N) )\n* Serious infection such as bacteremia, sepsis\n* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information\n* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma)\n* Positive HIV test\n* Positive urine pregnancy test\n* Combined with the other connective tissue diseases'}, 'identificationModule': {'nctId': 'NCT03365869', 'briefTitle': 'A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Phase Ⅱ Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'PKUPH-R-SRL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus', 'description': 'Add sirolimus according to the protocol. Sirolimus active: 2mg po. QD', 'interventionNames': ['Drug: Sirolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'sirolimus placebo: 2mg po. QD', 'interventionNames': ['Drug: Sirolimus']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Sirolimus or placebo were added to patients every day', 'armGroupLabels': ['Sirolimus', 'placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wuri Liga, Master', 'role': 'CONTACT', 'email': 'murongster@163.com', 'phone': '+8618801231167'}], 'overallOfficials': [{'name': 'Mu Rong, Poster', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Institute of Rheumatology and Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}