Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-29 @ 10:59 AM
Study NCT ID:
NCT01793259
Status:
COMPLETED
Last Update Posted:
2013-07-15
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-12', 'studyFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2013-02-14', 'lastUpdatePostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients preferring the MTX pre-filled pen to the pre-filled syringe', 'timeFrame': 'after 6 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '25125973', 'type': 'DERIVED', 'citation': 'Demary W, Schwenke H, Rockwitz K, Kastner P, Liebhaber A, Schoo U, Hubner G, Pichlmeier U, Guimbal-Schmolck C, Muller-Ladner U. Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience. Patient Prefer Adherence. 2014 Aug 6;8:1061-71. doi: 10.2147/PPA.S64111. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age between 18 and 75 years\n* Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010\n* Disease activity score (DAS) 28 \\> 2.6\n\nMain Exclusion Criteria:\n\n* Prior or other current subcutaneous treatment with self-injection\n* Prior or concomitant treatment with biologics\n* Contraindications to MTX treatment\n* History or diagnosis of a dermatological disease at the injection site\n* Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.'}, 'identificationModule': {'nctId': 'NCT01793259', 'briefTitle': 'Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'medac GmbH'}, 'officialTitle': "An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis", 'orgStudyIdInfo': {'id': 'MC-MTX.11/RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'prefilled pen then prefilled syringe', 'description': 'weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks', 'interventionNames': ['Drug: methotrexate prefilled pen', 'Drug: methotrexate prefilled syringe']}, {'type': 'OTHER', 'label': 'prefilled syringe then prefilled pen', 'description': 'weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks', 'interventionNames': ['Drug: methotrexate prefilled pen', 'Drug: methotrexate prefilled syringe']}], 'interventions': [{'name': 'methotrexate prefilled pen', 'type': 'DRUG', 'armGroupLabels': ['prefilled pen then prefilled syringe', 'prefilled syringe then prefilled pen']}, {'name': 'methotrexate prefilled syringe', 'type': 'DRUG', 'armGroupLabels': ['prefilled pen then prefilled syringe', 'prefilled syringe then prefilled pen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Clinic', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}], 'overallOfficials': [{'name': 'Ulf Müller-Ladner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kerckoff clinic, Bad Nauheim, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'medac GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}