Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 9:49 AM
Study NCT ID:
NCT01270035
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
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': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2011-06-23', 'studyFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of achieving remission at week 30', 'timeFrame': '30 weeks'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 \\< 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 \\< 2.6) at 30 weeks with this predifined treatment strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 \\> 5.1\n\nExclusion Criteria:\n\n* allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy'}, 'identificationModule': {'nctId': 'NCT01270035', 'briefTitle': 'Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate', 'organization': {'class': 'OTHER', 'fullName': 'Keio University'}, 'orgStudyIdInfo': {'id': 'ADA80MTX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADA 80 mg eow + MTX', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Adalimumab', 'type': 'DRUG', 'description': 'To increase the ADA dose from 40 mg eow to 80 mg eow', 'armGroupLabels': ['ADA 80 mg eow + MTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350-8550', 'city': 'Kawagoe', 'state': 'Saitama', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koichi Amano', 'role': 'CONTACT', 'email': 'amanokoi@saitama-med.ac.jp'}], 'facility': 'Saitama Medical Center', 'geoPoint': {'lat': 35.90861, 'lon': 139.48528}}, {'zip': '160-8582', 'city': 'Shinanomachi', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideto Kameda', 'role': 'CONTACT', 'email': 'kamehide@z6.keio.jp'}], 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.68194, 'lon': 139.72097}}], 'centralContacts': [{'name': 'Hideto Kameda, MD. PhD', 'role': 'CONTACT', 'email': 'kamehide@z6.keio.jp', 'phone': '+81-3-5843-6179'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keio University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saitama Medical University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hideto Kameda', 'oldOrganization': 'Keio University'}}}}