Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 10:30 AM
Study NCT ID:
NCT00818168
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Trial results belong to the SPONSOR only, all investigators are not allowed to publish trial results without permission of the SPONSOR.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)', 'otherNumAtRisk': 320, 'otherNumAffected': 0, 'seriousNumAtRisk': 320, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'lupus-like disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:\n\n* Yes\n* No\n* Missing", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.'}, {'type': 'SECONDARY', 'title': 'Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'classes': [{'title': 'BASDAI at Time of Enrollment (n=268)', 'categories': [{'measurements': [{'value': '5.15', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'BASDAI at First Infusion (n=82)', 'categories': [{'measurements': [{'value': '5.19', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and time of first infusion', 'description': 'The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Includes 78 participants whose completer/non-completer status was not reported (missing)', 'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Reason for Non-completion Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were those with Ankylosing spondylitis (AS) starting treatment with Remicade at 26 sites in Germany from Jul 2003 through Dec 2010'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.99', 'spread': '12.02', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '210', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-02', 'studyFirstSubmitDate': '2009-01-06', 'resultsFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-22', 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)"}, {'measure': 'Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)"}, {'measure': 'Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:\n\n* Yes\n* No\n* Missing (represents no entry, but may mean another test was performed as first screening test and documented)"}, {'measure': 'Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment', 'timeFrame': 'Baseline', 'description': "In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:\n\n* Yes\n* No\n* Missing"}], 'secondaryOutcomes': [{'measure': 'Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion', 'timeFrame': 'Baseline and time of first infusion', 'description': 'The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spondylitis, Ankylosing']}, 'descriptionModule': {'briefSummary': 'This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).', 'detailedDescription': 'This study population was chosen from a non-probability sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with ankylosing spondylitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with ankylosing spondylitis.\n\nExclusion Criteria:\n\n* As per Summary of Product Characteristics (SmPC)'}, 'identificationModule': {'nctId': 'NCT00818168', 'briefTitle': 'Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Remicade Safety Line (Ankylosing Spondylitis)', 'orgStudyIdInfo': {'id': 'P03275'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infliximab', 'description': 'Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)', 'interventionNames': ['Biological: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade', 'SCH 215596'], 'description': 'Dosage and infusion intervals were employed in\n\naccordance to the Summary of Product Characteristics (SmPC)', 'armGroupLabels': ['Infliximab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}