Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-29 @ 7:22 AM
Study NCT ID:
NCT00642902
Status:
TERMINATED
Last Update Posted:
2016-05-24
First Post:
2008-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C524618', 'term': 'TACI receptor-IgG Fc fragment fusion protein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Serono, a division of Merck KGaA'}, 'certainAgreement': {'otherDetails': 'Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Sponsor voluntarily decided to prematurely terminate this trial due to an increase in multiple sclerosis (MS) disease activity observed in atacicept arms as compared to placebo during a routine independent data monitoring committee (IDMC) review.'}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug administration up to 12 weeks after the last dose of the study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.', 'otherNumAtRisk': 63, 'otherNumAffected': 33, 'seriousNumAtRisk': 63, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.', 'otherNumAtRisk': 63, 'otherNumAffected': 30, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.', 'otherNumAtRisk': 63, 'otherNumAffected': 34, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.', 'otherNumAtRisk': 65, 'otherNumAffected': 44, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Body temperature decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'OG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'OG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '6.77'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '5.27'}, {'value': '2.30', 'groupId': 'OG002', 'lowerLimit': '1.08', 'upperLimit': '4.92'}, {'value': '2.49', 'groupId': 'OG003', 'lowerLimit': '1.18', 'upperLimit': '5.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12 to 36', 'description': 'Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).', 'unitOfMeasure': 'lesions/participant/scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of New T1 Gd-enhancing Lesions Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'OG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'OG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Week 12 (n=55, 45, 50, 55)', 'categories': [{'measurements': [{'value': '2.55', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '7.67', 'groupId': 'OG001'}, {'value': '3.20', 'spread': '6.41', 'groupId': 'OG002'}, {'value': '2.96', 'spread': '6.58', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 (n=41, 34, 37, 41)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '2.96', 'groupId': 'OG002'}, {'value': '1.54', 'spread': '2.94', 'groupId': 'OG003'}]}]}, {'title': 'Week 36 (n=23, 22, 24, 26)', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '5.09', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '1.93', 'groupId': 'OG002'}, {'value': '0.54', 'spread': '1.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24, 36', 'description': 'Analysis of new T1 Gd-enhancing lesions was done using MRI scans.', 'unitOfMeasure': 'lesions/participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. 'n' signifies participants who were evaluable for this measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free From Relapses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'OG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'OG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '71.9', 'groupId': 'OG002'}, {'value': '61.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 36', 'description': "A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature \\[axillary, orally, or intrauriculary\\] greater than (\\>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'OG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'OG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug administration up to 12 weeks after the last dose of the study drug', 'description': 'An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of treatment (either active or placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'FG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'FG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'FG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Premature termination of clinical trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Randomized, but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '255', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'BG001', 'title': 'Atacicept 25 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.'}, {'id': 'BG002', 'title': 'Atacicept 75 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.'}, {'id': 'BG003', 'title': 'Atacicept 150 mg', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '38.0', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '37.5', 'spread': '10.5', 'groupId': 'BG003'}, {'value': '37.7', 'spread': '9.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'whyStopped': 'Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-15', 'studyFirstSubmitDate': '2008-03-21', 'resultsFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2008-03-24', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-15', 'studyFirstPostDateStruct': {'date': '2008-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan', 'timeFrame': 'Weeks 12 to 36', 'description': 'Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).'}], 'secondaryOutcomes': [{'measure': 'Number of New T1 Gd-enhancing Lesions Per Participant', 'timeFrame': 'Weeks 12, 24, 36', 'description': 'Analysis of new T1 Gd-enhancing lesions was done using MRI scans.'}, {'measure': 'Percentage of Participants Free From Relapses', 'timeFrame': 'Baseline up to Week 36', 'description': "A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature \\[axillary, orally, or intrauriculary\\] greater than (\\>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'From the first dose of study drug administration up to 12 weeks after the last dose of the study drug', 'description': 'An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Relapsing Multiple Sclerosis', 'Atacicept'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '24613349', 'type': 'DERIVED', 'citation': 'Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.'}], 'seeAlsoLinks': [{'url': 'http://www.mslifelines.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Have primary progressive multiple sclerosis (MS)\n* Have secondary progressive MS without superimposed relapses\n* Relevant cardiac, hepatic and renal diseases as specified in the protocol\n* Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol\n* Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol\n* Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT00642902', 'acronym': 'ATAMS', 'briefTitle': 'A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course', 'orgStudyIdInfo': {'id': '28063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atacicept 25 mg', 'interventionNames': ['Drug: Atacicept']}, {'type': 'EXPERIMENTAL', 'label': 'Atacicept 75 mg', 'interventionNames': ['Drug: Atacicept']}, {'type': 'EXPERIMENTAL', 'label': 'Atacicept 150 mg', 'interventionNames': ['Drug: Atacicept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo matched to atacicept']}], 'interventions': [{'name': 'Atacicept', 'type': 'DRUG', 'description': 'Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.', 'armGroupLabels': ['Atacicept 25 mg']}, {'name': 'Atacicept', 'type': 'DRUG', 'description': 'Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.', 'armGroupLabels': ['Atacicept 75 mg']}, {'name': 'Atacicept', 'type': 'DRUG', 'description': 'Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.', 'armGroupLabels': ['Atacicept 150 mg']}, {'name': 'Placebo matched to atacicept', 'type': 'DRUG', 'description': 'Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'city': 'Jefferson', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.41895, 'lon': -71.47453}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': 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