Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT02488005
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction
Sponsor:
Organization:
Raw JSON
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specimen collection kit given to subjects', 'unitOfMeasure': 'mcg/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Small Bowel Ultrasound', 'description': 'Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '121'}]}]}, {'title': 'week 14', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 weeks', 'description': 'C-Reactive Protein (CRP) blood level', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 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'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 14', 'description': 'Anti-infliximab antibodies at week 14.', 'unitOfMeasure': 'U/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Small Bowel Ultrasound', 'description': 'Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Small Bowel Ultrasound', 'description': 'Subjects had a small bowel ultrasound done by a radiologist or ultrasound technician to measure bowel wall thickness at Week 0 and Week 14.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-27', 'size': 508033, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-19T10:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-19', 'studyFirstSubmitDate': '2015-06-29', 'resultsFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-19', 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bowel Wall Thickness (BWT)', 'timeFrame': 'Baseline and Week 14', 'description': 'Change in Bowel Wall Thickness at week 14 as compared to baseline, prior to initiating infliximab (IFX 0).'}, {'measure': "Change in Weighted Pediatric Crohn's Disease Activity Index (wPCDAI)", 'timeFrame': 'Baseline and Week 14', 'description': 'wPCDAI at week 14 as compared to baseline. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease.'}], 'secondaryOutcomes': [{'measure': 'Change in Fecal Calprotectin', 'timeFrame': 'Baseline and Week 14', 'description': 'change in fecal calprotectin at week 14 compared to baseline, using a specimen collection kit given to subjects'}, {'measure': 'C-Reactive Protein', 'timeFrame': '14 weeks', 'description': 'C-Reactive Protein (CRP) blood level'}, {'measure': 'Change in Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'baseline and 14 weeks', 'description': 'Change in Erythrocyte Sedimentation Rate (ESR) blood level at Week 14 from baseline'}, {'measure': 'IFX Level', 'timeFrame': 'Week 14', 'description': 'Infliximab drug (IFX) level at week 14. normal levels are \\<0.4 µg/mL'}, {'measure': 'Anti-infliximab Antibodies (ATI)', 'timeFrame': 'Week 14', 'description': 'Anti-infliximab antibodies at week 14.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Small Bowel', "Crohn's Disease", 'Small Bowel Ultrasound'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '21987300', 'type': 'BACKGROUND', 'citation': 'Sauer CG, Kugathasan S, Martin DR, Applegate KE. Medical radiation exposure in children with inflammatory bowel disease estimates high cumulative doses. Inflamm Bowel Dis. 2011 Nov;17(11):2326-32. doi: 10.1002/ibd.21626. Epub 2011 Jan 13.'}, {'pmid': '23583097', 'type': 'BACKGROUND', 'citation': 'Panes J, Bouhnik Y, Reinisch W, Stoker J, Taylor SA, Baumgart DC, Danese S, Halligan S, Marincek B, Matos C, Peyrin-Biroulet L, Rimola J, Rogler G, van Assche G, Ardizzone S, Ba-Ssalamah A, Bali MA, Bellini D, Biancone L, Castiglione F, Ehehalt R, Grassi R, Kucharzik T, Maccioni F, Maconi G, Magro F, Martin-Comin J, Morana G, Pendse D, Sebastian S, Signore A, Tolan D, Tielbeek JA, Weishaupt D, Wiarda B, Laghi A. Imaging techniques for assessment of inflammatory bowel disease: joint ECCO and ESGAR evidence-based consensus guidelines. J Crohns Colitis. 2013 Aug;7(7):556-85. doi: 10.1016/j.crohns.2013.02.020. Epub 2013 Apr 11.'}, {'pmid': '22398077', 'type': 'BACKGROUND', 'citation': "Calabrese E, Zorzi F, Zuzzi S, Ooka S, Onali S, Petruzziello C, Lasinio GJ, Biancone L, Rossi C, Pallone F. Development of a numerical index quantitating small bowel damage as detected by ultrasonography in Crohn's disease. J Crohns Colitis. 2012 Sep;6(8):852-60. doi: 10.1016/j.crohns.2012.01.015. Epub 2012 Feb 23."}, {'pmid': '21122521', 'type': 'BACKGROUND', 'citation': "Onali S, Calabrese E, Petruzziello C, Zorzi F, Sica GS, Lolli E, Ascolani M, Condino G, Pallone F, Biancone L. Endoscopic vs ultrasonographic findings related to Crohn's disease recurrence: a prospective longitudinal study at 3 years. J Crohns Colitis. 2010 Sep;4(3):319-28. doi: 10.1016/j.crohns.2009.12.010. Epub 2010 Feb 19."}, {'pmid': '24813174', 'type': 'BACKGROUND', 'citation': "Zorzi F, Stasi E, Bevivino G, Scarozza P, Biancone L, Zuzzi S, Rossi C, Pallone F, Calabrese E. A sonographic lesion index for Crohn's disease helps monitor changes in transmural bowel damage during therapy. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2071-7. doi: 10.1016/j.cgh.2014.04.036. Epub 2014 May 6."}, {'pmid': '23835441', 'type': 'BACKGROUND', 'citation': "Castiglione F, Testa A, Rea M, De Palma GD, Diaferia M, Musto D, Sasso F, Caporaso N, Rispo A. Transmural healing evaluated by bowel sonography in patients with Crohn's disease on maintenance treatment with biologics. Inflamm Bowel Dis. 2013 Aug;19(9):1928-34. doi: 10.1097/MIB.0b013e31829053ce."}, {'pmid': '24613399', 'type': 'BACKGROUND', 'citation': "Moreno N, Ripolles T, Paredes JM, Ortiz I, Martinez MJ, Lopez A, Delgado F, Moreno-Osset E. Usefulness of abdominal ultrasonography in the analysis of endoscopic activity in patients with Crohn's disease: changes following treatment with immunomodulators and/or anti-TNF antibodies. J Crohns Colitis. 2014 Sep;8(9):1079-87. doi: 10.1016/j.crohns.2014.02.008. Epub 2014 Mar 7."}, {'pmid': '19267199', 'type': 'BACKGROUND', 'citation': "Paredes JM, Ripolles T, Cortes X, Martinez MJ, Barrachina M, Gomez F, Moreno-Osset E. Abdominal sonographic changes after antibody to tumor necrosis factor (anti-TNF) alpha therapy in Crohn's Disease. Dig Dis Sci. 2010 Feb;55(2):404-10. doi: 10.1007/s10620-009-0759-7. Epub 2009 Mar 7."}, {'pmid': '21351206', 'type': 'BACKGROUND', 'citation': "Turner D, Griffiths AM, Walters TD, Seah T, Markowitz J, Pfefferkorn M, Keljo D, Waxman J, Otley A, LeLeiko NS, Mack D, Hyams J, Levine A. Mathematical weighting of the pediatric Crohn's disease activity index (PCDAI) and comparison with its other short versions. Inflamm Bowel Dis. 2012 Jan;18(1):55-62. doi: 10.1002/ibd.21649. Epub 2011 Feb 23."}, {'pmid': '32453126', 'type': 'DERIVED', 'citation': "Dolinger MT, Choi JJ, Phan BL, Rosenberg HK, Rowland J, Dubinsky MC. Use of Small Bowel Ultrasound to Predict Response to Infliximab Induction in Pediatric Crohn's Disease. J Clin Gastroenterol. 2021 May-Jun 01;55(5):429-432. doi: 10.1097/MCG.0000000000001367."}]}, 'descriptionModule': {'briefSummary': "Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free, low cost measure to assess inflammatory bowel disease (IBD), and is being used as first-line imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a small number of recent studies have looked at change in bowel wall thickness (BWT) in response to anti-tumor necrosis factor (anti-TNF) therapy. However, the use of SBUS to detect response to anti-TNF therapy has not been tested in pediatric patients. The purpose of this study is to apply the use of SBUS to pediatric patients with Crohn's disease and to assess response to treatment with infliximab. The investigators will also measure C-reactive protein and fecal calprotectin at baseline, and additionally measuring IFX levels and anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment, as well as correlation between these markers with changes in patient reported outcomes via a weighted pediatric Crohn's disease activity questionnaire (wPCDAI) and changes in BWT. This study is novel in that it will be the first study in pediatric patients to use SBUS to assess response to IFX therapy, and will also be the first study to correlate SBUS findings with therapeutic drug monitoring (TDM). This study has the potential to propagate the use of SBUS in the pediatric population, as the use of TDM in concert with small bowel imaging post-induction will allow the investigators to tailor therapy early in the treatment course.", 'detailedDescription': "Pediatric inflammatory bowel disease (IBD) patients are at increased risk for high ionizing radiation exposure in the assessment of their condition. Small bowel ultrasound (SBUS) is emerging as a well tolerated, non-invasive, radiation free, low cost measure to assess inflammatory bowel disease, and is being used as first-line imaging in Europe. SBUS findings have been shown to correlate with endoscopic findings, and a small number of recent studies have looked at change in bowel wall thickness (BWT), in response to anti-TNF therapy.\n\nThe use of SBUS to detect response to anti-TNF therapy has not been tested in pediatric patients. In addition, these studies frequently use Crohn's Disease Activity Index (CDAI) as a measure of clinical activity, yet it is known from multiple studies including the SONIC trial that CDAI is not a reliable or accurate measure to predict mucosal healing. A weighted PCDAI will be used instead, which has been shown to perform better than the original PCDAI and is more feasible, especially considering the study spans 14 weeks and scoring items such as height velocity from the full PCDAI will be irrelevant.\n\nThe goal of this study is to measure bowel wall thickness (BWT) prior to initiating infliximab (IFX 0) and at week 14 and to look at the correlation between change in BWT (delta BWT) with change in clinical disease activity (delta wPCDAI) between these two time points. The research team will measure fecal calprotectin at baseline and at week 14 with stool collected the day prior to the visit using a specimen collection kit given to subjects. The research team will also collect results from routine laboratories (including C-Reactive Protein, Erythrocyte Sedimentation Rate, Complete Blood Count, and Albumin) done before each infusion, and IFX levels and anti-infliximab antibodies (ATI) at week 14 to assess change in biochemical response to infliximab treatment, as well as correlation between these markers with changes in patient reported outcomes (via a wPCDAI questionnaire) and changes in BWT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No infliximab therapy previously initiated\n* Infliximab indicated for treatment of IBD\n* Patient consent/assent and/or parent/guardian consent\n* Ability to remain in follow-up for 14 weeks from start of study\n\nExclusion Criteria:\n\n* Lack of small bowel disease\n* Inability to give consent or adhere to study protocol\n* Infliximab-experienced\n* Presence of active infections\n* Presence of abscess or strictures\n* Current or planned Pregnancy for the 14 week study duration'}, 'identificationModule': {'nctId': 'NCT02488005', 'briefTitle': 'The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction', 'orgStudyIdInfo': {'id': 'GCO 15-0878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Small Bowel Ultrasound', 'description': 'Subjects will receive a small bowel ultrasound to measure bowel wall thickness at Week 0 and Week 14', 'interventionNames': ['Device: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'An ultrasound of the small bowel will be done by a radiologist or ultrasound technician. Subject should not eat or drink anything (i.e. no food and no water/beverages) for 8 hours prior to their ultrasound appointment', 'armGroupLabels': ['Small Bowel Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Marla C. Dubinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}