Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT05424393
Status:
RECRUITING
Last Update Posted:
2022-06-21
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'no need'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical remission defined by DAS28', 'timeFrame': '48 weeks', 'description': 'Clinical efficacy: Clinical remission rate achieved at 48 weeks'}], 'secondaryOutcomes': [{'measure': 'clinical remission rate of RA at weeks 24, 96 and 144', 'timeFrame': 'weeks 24, 96 and 144', 'description': 'clinical remission rate of RA at weeks 24, 96 and 144'}, {'measure': 'low disease activity rate of RA at weeks 24, 48, 96 and 144', 'timeFrame': 'weeks 24, 48, 96 and 144', 'description': 'low disease activity rate of RA at weeks 24, 48, 96 and 144'}, {'measure': 'joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144', 'timeFrame': 'weeks 24, 48, 96 and 144', 'description': 'joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144'}, {'measure': 'improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144', 'timeFrame': 'weeks 24, 48, 96 and 144', 'description': 'improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144'}, {'measure': 'scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144', 'timeFrame': 'weeks 24, 48, 96 and 144', 'description': 'scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 ，144'}, {'measure': 'rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144', 'timeFrame': 'weeks 24, 48, 96 and 144', 'description': 'rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144'}, {'measure': 'changes of carotid intima-media thickness at weeks 48 and 144', 'timeFrame': 'weeks 48 and 144', 'description': 'changes of carotid intima-media thickness at weeks 48 and 144'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clincal remission; low disease activity'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years', 'detailedDescription': 'This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'RA patients in routine clinical practice environments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria:\n\n* Meet the ACR revised RA classification criteria(2010);\n* Disease duration is more than or equal to 6 weeks;\n* DAS28-CRP\\>2.6;\n* Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;\n* A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.\n\nExclusion Criteria:\n\nExclusion criteria:\n\n* Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;\n* Patient is participating in other ongoing drug clinical trials;\n* Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;\n* Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;\n* Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;\n* Other reasons the researchers think the patient is not eligible for participation in the study.'}, 'identificationModule': {'nctId': 'NCT05424393', 'acronym': 'LORMYF', 'briefTitle': 'Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China', 'orgStudyIdInfo': {'id': 'FJ_RA_RWS_2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RA Patients receiving routine treatment', 'description': 'During the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years.', 'interventionNames': ['Drug: YISAIPU® ( An etanercept biosimilar)', 'Drug: csDMARDs']}], 'interventions': [{'name': 'YISAIPU® ( An etanercept biosimilar)', 'type': 'DRUG', 'otherNames': ['a recombinant tumor necrosis factor receptor-Fc fusion protein', 'rhTNFR:Fc'], 'description': 'YISAIPU®, an etanercept biosimilar produced by 3SBio Inc., is a TNF-α inhibitor targeting soluble TNF-α to inhibit its interaction with cell-surface receptors. It has been widely used in clinical practice for 17 years in China. According to the prescription information, YISAIPU should be given as 25mg, biw, pc.', 'armGroupLabels': ['RA Patients receiving routine treatment']}, {'name': 'csDMARDs', 'type': 'DRUG', 'description': 'csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.', 'armGroupLabels': ['RA Patients receiving routine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Li, PHD/MD', 'role': 'CONTACT', 'email': 'liy010203@163.com', 'phone': '8615960263763'}], 'facility': 'The First Affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Guixiu Shi, MD PHD', 'role': 'CONTACT', 'email': 'gshi@xmu.edu.cn', 'phone': '8613600932661'}, {'name': 'Yan Li, MD PHD', 'role': 'CONTACT', 'email': 'liy010203@163.com', 'phone': '8615960263763'}], 'overallOfficials': [{'name': 'Guixiu Shi, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Xiamen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'until completed', 'ipdSharing': 'YES', 'description': 'share the study protocol', 'accessCriteria': 'Scholars in rheumatism'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}