Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT00507403
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2007-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infliximab and Methotrexate in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2007-07-24', 'studyFirstSubmitQcDate': '2007-07-24', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic properties of infliximab in AS patients with or without methotrexate', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Individual pharmacokinetic modelisation of infliximab', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '21639907', 'type': 'DERIVED', 'citation': 'Mulleman D, Lauferon F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350.'}]}, 'descriptionModule': {'briefSummary': 'There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.\n\nThus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ankylosing spondylitis\n* Needing anti-TNF drugs\n\nExclusion Criteria:\n\n* Contra-indications to anti-TNF drugs'}, 'identificationModule': {'nctId': 'NCT00507403', 'acronym': 'SPAXIM', 'briefTitle': 'Infliximab and Methotrexate in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'PHRR/04/PG-SPAXIM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab', 'description': 'Infliximab', 'interventionNames': ['Drug: infliximab']}, {'type': 'EXPERIMENTAL', 'label': 'Infliximab +methotrexate', 'description': 'Infliximab +methotrexate', 'interventionNames': ['Drug: infliximab']}], 'interventions': [{'name': 'infliximab', 'type': 'DRUG', 'armGroupLabels': ['Infliximab', 'Infliximab +methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital Jean MINJOZ -Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'University hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'PHILIPPE GOUPILLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Tours, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}