Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-01 @ 3:41 AM
Study NCT ID:
NCT00902369
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
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': 'C000656266', 'term': 'AK106-001616'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2009-05-14', 'studyFirstSubmitQcDate': '2009-05-14', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['AK106-001616'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25579091', 'type': 'DERIVED', 'citation': 'Kozaki T, Tagashira M, Yamanishi K, Ellis B, Kayanoki T, Ooishi R, Sugiyama K, Matsuda S, Tsuruta K, Kohira T, Tsurui K. Evaluation of drug-drug interaction between the novel cPLA2 inhibitor AK106-001616 and methotrexate in rheumatoid arthritis patients. Xenobiotica. 2015;45(7):615-24. doi: 10.3109/00498254.2014.1000430. Epub 2015 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RA (class I to III)\n* Stable dose of methotrexate (at least 12 weeks)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Abnormal screening laboratory test values considered to be clinically significant'}, 'identificationModule': {'nctId': 'NCT00902369', 'briefTitle': 'A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asahi Kasei Pharma Corporation'}, 'orgStudyIdInfo': {'id': 'AK106 II-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK106-001616', 'interventionNames': ['Drug: AK106-001616']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part1: AK106-001616 and Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active comparator', 'description': 'Part2: AK106-001616 and Active comparator', 'interventionNames': ['Drug: Active comparator']}], 'interventions': [{'name': 'AK106-001616', 'type': 'DRUG', 'description': 'Part1: Dose escalation Part2: Dose expansion', 'armGroupLabels': ['AK106-001616']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': 'Active comparator', 'type': 'DRUG', 'armGroupLabels': ['Active comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hlučín', 'country': 'Czechia', 'geoPoint': {'lat': 49.89795, 'lon': 18.19196}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Érd', 'country': 'Hungary', 'geoPoint': {'lat': 47.39489, 'lon': 18.91361}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asahi Kasei Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}