Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-03-05 @ 12:06 AM
Study NCT ID:
NCT03221166
Status:
TERMINATED
Last Update Posted:
2020-09-04
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013792', 'term': 'Thalidomide'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Difficulty in recruiting subjects who meet the inclusion/exclusion criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in inducing mucosal healing', 'timeFrame': '52 weeks', 'description': 'Proportion of patients that achieve mucosal healing, defined by a Simplified Endoscopic Activity Index for CD (SES-CD) ≤ 2.'}], 'secondaryOutcomes': [{'measure': 'Efficacy in inducing clinical response', 'timeFrame': '12 weeks', 'description': "Clinical response will be evaluated with the weighted Pediatric Crohn's Disease Activity Index (wPCDAI), defined by a reduction of wPCDAI \\> 50% from the basal values."}, {'measure': 'Efficacy in inducing clinical response', 'timeFrame': '52 weeks', 'description': "Clinical response will be evaluated with the weighted Pediatric Crohn's Disease Activity Index (wPCDAI), defined by a reduction of wPCDAI \\> 50% from the basal values."}, {'measure': 'Efficacy in inducing clinical remission', 'timeFrame': '12 weeks', 'description': "Clinical remission will be evaluated with the weighted Pediatric Crohn's Disease Activity Index (wPCDAI), defined by a wPCDAI \\<12.5."}, {'measure': 'Efficacy in inducing clinical remission', 'timeFrame': '52 weeks', 'description': "Clinical remission will be evaluated with the weighted Pediatric Crohn's Disease Activity Index (wPCDAI), defined by a wPCDAI \\<12.5."}, {'measure': 'Efficacy in reducing the need to change therapy', 'timeFrame': '12 weeks', 'description': 'Evaluation of the proportion of patients that need a therapeutic change'}, {'measure': 'Efficacy in reducing the need to change therapy', 'timeFrame': '52 weeks', 'description': 'Evaluation of the proportion of patients that need a therapeutic change'}, {'measure': 'Efficacy in reducing hospitalizations', 'timeFrame': '52 weeks', 'description': 'Evaluation of the proportion of patients that need hospitalization.'}, {'measure': 'Efficacy in reducing the need for surgery', 'timeFrame': '52 weeks', 'description': 'Evaluation of the proportion of patients that need surgery'}, {'measure': 'Efficacy in reducing erythrocyte sedimentation rate', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of erythrocyte sedimentation rate (ESR)'}, {'measure': 'Efficacy in reducing C-reactive protein', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of C-reactive protein (CRP)'}, {'measure': 'Efficacy in reducing faecal calprotectin', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of faecal calprotectin'}, {'measure': 'Efficacy in modifying body mass index', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of body mass index, defined as weight (kg)/height (m)\\^2'}, {'measure': 'Efficacy in modifying height-for-age z score', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of height-for-age z score'}, {'measure': 'Efficacy in modifying weight-for-age z score', 'timeFrame': 'Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)', 'description': 'Evaluation of the trend of weight-for-age z score'}, {'measure': 'Evaluation of the Treatment-Emergent Adverse Events', 'timeFrame': 'Between enrolment and 52 weeks', 'description': 'Number and type'}, {'measure': 'Direct and indirect costs', 'timeFrame': '52 weeks', 'description': 'Comparison of direct and indirect costs (i.e. drugs, medical supplies and equipment, laboratory and diagnostic tests, hospitalizations, visits, transportation to and from healthcare facilities, missing work and school days…) between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Crohn disease', 'Thalidomide', 'Mucosal healing'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Crohn's disease (CD) is a life-long inflammatory bowel disease disease with an unknown pathogenesis. The ultimate goal of therapy is to modify the natural history of CD thus reducing complications. Thalidomide is a small molecule with immunomodulatory and anti-angiogenetic properties. It is currently approved for the treatment of erythema nodosum leprosum, an immunological complication of leprosy and multiple myeloma. It has also been used in several other inflammatory diseases of the skin and of the mucosal membranes, such as Behcet disease, oropharyngeal ulcers in AIDS, cutaneous lupus, and graft versus host disease. Many case series and one pediatric randomized controlled trial proved the efficacy of thalidomide in the treatment of children with CD refractory to standard treatments. In these patients, clinical remission was achieved in about 50% of the cases and was maintained for a mean time superior of 3 years. Mucosal healing after 52 weeks of treatment was observed in 40% of the patients in clinical remission. Moreover, thalidomide was found to have a steroid-sparing effect and to decrease the need for surgical interventions. The clinical and endoscopic efficacy of thalidomide was also observed in children with failure to respond or intolerance to anti-TNF biological drugs.\n\nThe aim of this multicentric prospective randomized controlled is to evaluate the efficacy and safety of thalidomide vs infliximab in changing the natural history of CD in patients with poor prognostic outcome. Moreover, the study will evaluate the immunological and genetical mechanisms of CD, the mechanisms of action thalidomide in CD and will the pharmacokinetics, metabolomics and pharmacogenomics of thalidomide, and their impact on thalidomide safety and effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at diagnosis \\<18 years and \\>=6 years\n* New diagnosis of CD based on Porto criteria\n* CD with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for surgery except for perinal fistulas\n* Presence of at least one of the following risk factors for poor prognosis:\n\n * fistulizing perianal disease\n * pan-enteric disease\n * disease extension \\> 60 cm\n * severe growth delay (height z-score \\< -2 DS)\n * severe osteoporosis (z score \\< -2 DS)\n * hypoalbuminemia (\\< 3g/dL) or high C-reactive protein (2 times higher the normal range)\n* Acceptance of the Risk Evaluation and Mitigation Strategy (REMS) program for reducing the teratogenic risk.\n\nExclusion Criteria:\n\n* ongoing pregnancy\n* presence of peripheral neuropathy\n* HIV\n* patients with transplanted organs\n* ongoing major infections or other severe diseases\n* participation to other experimental studies.'}, 'identificationModule': {'nctId': 'NCT03221166', 'briefTitle': "Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors", 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': "Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network", 'orgStudyIdInfo': {'id': 'NET-2013-02355002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thalidomide', 'description': 'Thalidomide is a immunomodulatory and antiangiogenetic drug with anti tumor necrosis factor (TNF) alpha properties', 'interventionNames': ['Drug: Thalidomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab', 'description': 'Infliximab is a chimeric monoclonal antibody against TNF alpha', 'interventionNames': ['Drug: Infliximab']}], 'interventions': [{'name': 'Thalidomide', 'type': 'DRUG', 'description': 'Thalidomide is a immunomodulatory and antiangiogenetic drug with anti TNF alpha properties', 'armGroupLabels': ['Thalidomide']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': 'Infliximab is a chimeric monoclonal antibody against TNF alpha', 'armGroupLabels': ['Infliximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'Dipartimento di Pediatria dell\'Università di Napoli "Federico II"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '34137', 'city': 'Trieste', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '16147', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'Pediatria III Gastroenterologia ed Endoscopia Digestiva, Istituto Giannina Gaslini', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '20052', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione MBBM , Azienda Ospedaliera San Gerardo - Università Milano Bicocca', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '98124', 'city': 'Messina', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Unità di Gastroenterologia Pediatrica e Fibrosi Cistica, Dipartimento di Scienze Pediatriche Mediche e Chirurgiche, Policlinico Universitario', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Gastroenterologia e Nutrizione Pediatrica, Azienda Ospedaliero Universitaria Meyer', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Alessandro Ventura, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS Burlo Garofolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}