Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT01567358
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2012-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of NI-071 in Comparison With Remicade 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': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety : Incidence of Adverse Events', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'PK : Area under the serum concentration versus time curve(AUC)', 'timeFrame': '14 weeks'}, {'measure': 'Efficacy : ACR core-set', 'timeFrame': '14 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months\n2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg\\~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit\n\nExclusion Criteria:\n\n1. History of following diseases\n\n * Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment\n * Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）\n * Severe infectious disease（hepatitis, pneumonia、sepsis）\n * History of demyelinating disease or multiple sclerosis\n * Congestive heart failure\n * lymphoproliferative disorder or myelodysplastic syndrome\n * History of malignancy\n * Interstitial lung disease\n2. Patients with active or latent tuberculosis or history of tuberculosis'}, 'identificationModule': {'nctId': 'NCT01567358', 'briefTitle': 'Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nichi-Iko Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate', 'orgStudyIdInfo': {'id': 'NI071C1(ACT12719)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NI-071', 'interventionNames': ['Biological: Infliximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remicade', 'interventionNames': ['Biological: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'BIOLOGICAL', 'description': '100mg/vial', 'armGroupLabels': ['NI-071']}, {'name': 'Infliximab', 'type': 'BIOLOGICAL', 'description': '100mg/vial', 'armGroupLabels': ['Remicade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '982-0032', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': '392001001', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nichi-Iko Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}