Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-13 @ 5:41 AM
Study NCT ID:
NCT02005757
Status:
UNKNOWN
Last Update Posted:
2015-06-26
First Post:
2013-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)
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': 'C010052', 'term': 'mizoribine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'RA', 'Mizoribine', 'DAS28', 'European League Against Rheumatism'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.', 'detailedDescription': '1. EULAR Response after 24weeks of treatment\n2. EULAR Response after 12weeks of treatment\n3. DAS28 value change\n4. KHAQ-20 value change'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged from 20 to 80 years old\n* Signed and dated informed consent document indicating that the patient\n* Patients must have a diagnosis of Rheumatoid Arthritis(RA) of at least 3months duration as defined by the 2010 American College of Rheumatology(ACR) Classification criteria.\n* Patients should have a Disease Activity Score 28 greater than or equal to 3.2 (DAS28 ≥ 3.2) and have received treatment with more than 1 kind of disease-modifying antirheumatic drug(including MTX).\n* ESR≥28mm/h or CRP≥1.0mg/dl at screening.\n\nExclusion Criteria\n\n* At screening, patients have laboratory result as defined by : white blood cell ≤ 3,000/mm3\n\n , Hemoglobin \\< 8.5 g/dL, Platelet count \\< 100,000/mm3, Serum creatinine \\> 2.0 mg/dL, Aspartic Acid Transaminase/Alanine Transaminase ≥ 2\\*upper limit of normal , Uric acid ≥ 1.5\\*upper limit of normal\n* Patient must not have bleeding disorder or taking anticoagulant. (But, lt is allowed to take 100mg/day of Asprin)\n* Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.\n* Patients have severe infection, including moderate respiratory disease and have received treatment with systemic antibiotics within 2 weeks.\n* Patients have cardiovascular disease or associated disease which is not controlled.\n* Patients have a history of malignancy within 5years. (But, basal cell or squamous cell carcinoma or carcinoma in situ of the uterine cervix have been treated is allowed)\n* Patients have hypersensitivity reaction on this drug.\n* Patients on any other clinical trial or experimental treatment in the past 3months.\n* Female patients who are breast feeding, pregnant or plan to become pregnant during the trial or for two months following study termination.\n* Not allowable medication recorded below ; Intra-articular injections within weeks at baseline visit, Patients taking oral steroid over 10mg /day or using new treatment or changing dosage within 4weeks at baseline visit, Using new nonsteroidal antiinflammatory drug within 4 weeks or changing nonsteroidal antiinflammatory drug dosage within 2 weeks at baseline visit.\n* Having experience of use biologic agent, immunosuppressant, cytostatic preparations within 8weeks at baseline visit. (But, Rituximab is not allowed within 6months)\n* Start to treatment new disease-modifying antirheumatic drug or need to change dosage of disease-modifying antirheumatic drug which is taking on the trial. (Leflunomide(ARAVA®) is not allowed within 12weeks, But, Cholestyramine is allowed after 48 hours later stopping. if it use three times a day, 8g, for 11days)'}, 'identificationModule': {'nctId': 'NCT02005757', 'acronym': 'AMOLED', 'briefTitle': 'Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug', 'orgStudyIdInfo': {'id': '32RA13007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bredinin tablet 150mg', 'description': 'dosage form: Tablet, dosage: 150mg qd, Duration: for 6months', 'interventionNames': ['Drug: Bredinin tablet 150mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bredinin tablet 50mg', 'description': 'dosage form: Tablet, dosage: 50mg tid, Duration: for 6months', 'interventionNames': ['Drug: Bredinin tablet 50mg']}], 'interventions': [{'name': 'Bredinin tablet 150mg', 'type': 'DRUG', 'otherNames': ['Mizoribine'], 'description': 'Bredinin 150mg qd vs Bredinin 50mg tid', 'armGroupLabels': ['Bredinin tablet 150mg']}, {'name': 'Bredinin tablet 50mg', 'type': 'DRUG', 'otherNames': ['Mizoribine'], 'description': 'Bredinin 150mg qd vs Bredinin 50mg tid', 'armGroupLabels': ['Bredinin tablet 50mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Il Seo, PhD', 'role': 'CONTACT', 'email': 'yiseo@hallym.or.kr'}, {'name': 'Young-Il Seo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyeong Min Son, PhD', 'role': 'CONTACT', 'email': 'jollyfox@hanmail.net'}, {'name': 'Kyeong Min Son', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Donghyuk Sheen, PhD', 'role': 'CONTACT', 'email': 'rheuma@eulji.ac.kr'}, {'name': 'Donghyuk Sheen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eulji University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Soo Kim, Ph.D', 'role': 'CONTACT', 'email': 'drkiss@ulsan.ac.kr', 'phone': '82-33-610-3061'}, {'name': 'Sung-Soo Kim, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangneung Asan Hospital', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Kangwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kiwon Moon, PhD', 'role': 'CONTACT', 'email': 'kiwonmoon@kangwon.ac.kr'}, {'name': 'Kiwon Moon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangwon National University Hospital'}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Jae Hong, phD', 'role': 'CONTACT', 'email': 'hsj718@khu.ac.kr'}, {'name': 'Seung-Jae Hong, phD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyung Hee University hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-sook Kim, PhD', 'role': 'CONTACT', 'email': 'healthyra@schmc.ac.kr'}, {'name': 'Hyunsook Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soon Chun Hyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung Su Kim, M.D., Ph.D', 'role': 'CONTACT', 'email': 'DrKiss@korea.com', 'phone': '82-33-610-3126'}], 'overallOfficials': [{'name': 'Sung Su Kim, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Gangneng asan Medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}