Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-31 @ 8:56 AM
Study NCT ID:
NCT01317004
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2011-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}, {'id': 'D000068576', 'term': 'Interferon beta-1b'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.', 'otherNumAtRisk': 50, 'otherNumAffected': 13, 'seriousNumAtRisk': 50, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.', 'otherNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Human papilloma virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Patient-reported Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.57', 'spread': '21.00', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '16.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Activities of Daily Living (ADL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '1.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Reported Effectiveness and Convenience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'title': 'Effectiveness', 'categories': [{'measurements': [{'value': '13.53', 'spread': '28.39', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '32.40', 'groupId': 'OG001'}]}]}, {'title': 'Convenience', 'categories': [{'measurements': [{'value': '24.64', 'spread': '18.28', 'groupId': 'OG000'}, {'value': '12.78', 'spread': '25.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '3.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Health Related Quality of Life (QOL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'title': 'Physical functioning (n=41,9)', 'categories': [{'measurements': [{'value': '1.71', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '20.73', 'groupId': 'OG001'}]}]}, {'title': 'Role limitations due to physical health (n=42,9)', 'categories': [{'measurements': [{'value': '7.14', 'spread': '37.97', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '27.32', 'groupId': 'OG001'}]}]}, {'title': 'Pain (n=45,9)', 'categories': [{'measurements': [{'value': '6.56', 'spread': '24.32', 'groupId': 'OG000'}, {'value': '14.44', 'spread': '15.25', 'groupId': 'OG001'}]}]}, {'title': 'General health (n=44,8)', 'categories': [{'measurements': [{'value': '4.52', 'spread': '19.43', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '14.08', 'groupId': 'OG001'}]}]}, {'title': 'Energy/fatigue (n=43,9)', 'categories': [{'measurements': [{'value': '2.33', 'spread': '18.81', 'groupId': 'OG000'}, {'value': '6.48', 'spread': '33.24', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning (n=45,9)', 'categories': [{'measurements': [{'value': '7.78', 'spread': '24.90', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '25.85', 'groupId': 'OG001'}]}]}, {'title': 'Role limitations d/t emotional problems (n=45,9)', 'categories': [{'measurements': [{'value': '7.04', 'spread': '41.82', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '38.89', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being (n=43,9)', 'categories': [{'measurements': [{'value': '2.51', 'spread': '16.88', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '28.13', 'groupId': 'OG001'}]}]}, {'title': 'PCS (n=40,8)', 'categories': [{'measurements': [{'value': '4.52', 'spread': '18.05', 'groupId': 'OG000'}, {'value': '7.83', 'spread': '15.86', 'groupId': 'OG001'}]}]}, {'title': 'MCS (n=40,8)', 'categories': [{'measurements': [{'value': '5.88', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '24.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Physician-reported Clinical Global Impression of Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'OG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'classes': [{'title': 'Much improved', 'categories': [{'measurements': [{'value': '13.64', 'groupId': 'OG000'}, {'value': '11.11', 'groupId': 'OG001'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '36.36', 'groupId': 'OG000'}, {'value': '11.11', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '47.73', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000'}, {'value': '11.11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'FG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Actual enrollment = 61 because 65 participants were randomized to the study, but only 61 participants received at least one dose of study medication. As such, the participant flow captures the 65 participants randomized and the 61 participants who received drug as the safety set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.'}, {'id': 'BG001', 'title': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.96', 'spread': '8.69', 'groupId': 'BG000'}, {'value': '35.82', 'spread': '7.22', 'groupId': 'BG001'}, {'value': '37.57', 'spread': '8.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-18', 'studyFirstSubmitDate': '2011-03-15', 'resultsFirstSubmitDate': '2015-05-29', 'studyFirstSubmitQcDate': '2011-03-15', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-18', 'studyFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Patient-reported Treatment Satisfaction', 'timeFrame': 'baseline, 6 months', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Patient-reported Activities of Daily Living (ADL)', 'timeFrame': 'baseline, 6 months', 'description': 'The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Patient-reported Fatigue', 'timeFrame': '6 months', 'description': 'The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Patient-Reported Effectiveness and Convenience', 'timeFrame': '6 months', 'description': "The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement."}, {'measure': 'Change From Baseline in Patient-reported Depression', 'timeFrame': '6 months', 'description': 'The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Patient-reported Health Related Quality of Life (QOL)', 'timeFrame': '6 months', 'description': 'The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.'}, {'measure': 'Physician-reported Clinical Global Impression of Improvement (CGI-I)', 'timeFrame': '6 months', 'description': "The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement."}]}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Fingolimod', 'Disease Modifying Therapy', 'TSQM-9'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.\n* Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.\n* An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.\n* Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.\n* Naïve to treatment with fingolimod.\n\nExclusion Criteria:\n\n* A manifestation of MS other than those defined in the inclusion criteria.\n* A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Patients with uncontrolled diabetes mellitus (HbA1c \\> 7%).\n* Diagnosis of macular edema during Screening Phase.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01317004', 'acronym': 'EPOC', 'briefTitle': 'Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)', 'orgStudyIdInfo': {'id': 'CFTY720DIT02'}, 'secondaryIdInfos': [{'id': '2010-024017-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod', 'description': 'Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.', 'interventionNames': ['Drug: Fingolimod']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multiple Sclerosis Disease Modifying Treatment (MS DMT)', 'description': 'Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.', 'interventionNames': ['Drug: Standard MS DMT']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['GILENYA™'], 'description': '0.5 mg/day oral capsule', 'armGroupLabels': ['Fingolimod']}, {'name': 'Standard MS DMT', 'type': 'DRUG', 'otherNames': ['Avonex®,', 'Copaxone®,', 'Rebif®,', 'Betaferon®,', 'Extavia®'], 'description': 'Interferon beta 1a or interferon beta 1b or Glatiramer Acetate', 'armGroupLabels': ['Multiple Sclerosis Disease Modifying Treatment (MS DMT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Ancona', 'state': 'AN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '13900', 'city': 'Ponderano', 'state': 'BI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.53846, 'lon': 8.05592}}, {'zip': '93100', 'city': 'Caltanissetta', 'state': 'CL', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.49025, 'lon': 14.06216}}, {'zip': '12100', 'city': 'Cuneo', 'state': 'CN', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '22100', 'city': 'Como', 'state': 'CO', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '95122', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '71100', 'city': 'Foggia', 'state': 'FG', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '50051', 'city': 'Castelfiorentino', 'state': 'FI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.60963, 'lon': 10.96772}}, {'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20097', 'city': 'San Donato Milanese', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '41100', 'city': 'Modena', 'state': 'MO', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '90129', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '90146', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '56126', 'city': 'Pisa', 'state': 'PI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '37045', 'city': 'Legnago', 'state': 'VR', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.19365, 'lon': 11.30227}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Renato Turrini, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Farma S.p.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}