Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT01195857
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-03', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse', 'timeFrame': 'up to 6 month'}], 'secondaryOutcomes': [{'measure': 'Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist', 'timeFrame': 'up to 6 month'}, {'measure': 'Correlation with recent training within the last 6 months', 'timeFrame': 'up to 6 month'}, {'measure': 'Correlation with disease control (relapse rate)', 'timeFrame': 'up to 6 month'}, {'measure': 'Length of time on treatment', 'timeFrame': 'up to 6 month'}, {'measure': 'Presence of injection site reactions', 'timeFrame': 'up to 6 month'}, {'measure': 'Cognitive impairment', 'timeFrame': 'up to 6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Rebif', 'Interferon beta-1a'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': "Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31"}]}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.\n\nPrior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device\n* Be under regular review by a MS nurse\n* Be aged 18 or above\n* Be willing and able to participate in the trial and to have provided written informed consent\n\nExclusion Criteria:\n\n* Receiving disease modifying therapy other than Rebif\n* Receiving Rebif but not using the Rebiject II injection device\n* Do not self inject\n* Are unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01195857', 'briefTitle': 'Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration', 'orgStudyIdInfo': {'id': 'EMR701068-512'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dr Gillian L Shepherd, MD, MRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono Limited, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono Limited, UK', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}