Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:11 AM
Study NCT ID:
NCT07364734
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-16', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'steroid-free remission', 'timeFrame': 'From the beginning of enrollment to 1 year', 'description': 'Compare the steroid-free clinical remission rates of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs. "Steroid-free" refers to patients who do not receive concomitant steroid medication.'}], 'secondaryOutcomes': [{'measure': "Epidemiological status of Difficult-To-Treat Crohn's Disease", 'timeFrame': 'From the beginning of enrollment to three months later', 'description': 'Calculate the proportion of DTT-CD patients in the total population'}, {'measure': 'Clinical reponse rate', 'timeFrame': 'From the begining of enrollment to 1 year.', 'description': 'Compare the clinical response rates of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs.'}, {'measure': 'Clinical remission rate', 'timeFrame': 'From the begining of enrollment to 1 year', 'description': 'Compare the clinical remission rates of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs.'}, {'measure': 'Endoscopic outcome', 'timeFrame': 'From the begining of enrollment to 1 year', 'description': 'Compare the endoscopic outcomes of patients with DTT-CD and non DTT-CD during the induction and maintenance periods, including the endoscopic response rate, the endoscopic remission rate, and the mucusal healing rate in the patients using biologics or small molecule drugs.'}, {'measure': 'Ultrasound outcome', 'timeFrame': 'From the begining of enrollment to 1 year', 'description': 'Compare the ultrasound outcomes of patients with DTT-CD and non DTT-CD during the induction and maintenance periods in the patients using biologics or small molecule drugs, including the transmural response rate and the transmural remission rate.'}, {'measure': 'Postoperative recurrence rate', 'timeFrame': 'From the begining of enrollment to 1 year', 'description': 'Compare the postoperative recurrence rates of DTT-CD and non DTT-CD: postoperative recurrence is defined as the recurrence of clinical symptoms, or endoscopic mucosal ulcers, or imaging evidence of intestinal inflammation, etc.'}, {'measure': 'Safety differences', 'timeFrame': 'From the begining of enrollment to 1 year', 'description': 'Compare the safety differences between DTT-CD and non-DTT-CD after one year of biologic therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Difficult-To-Treat Crohn's Disease", 'Epidemiological Characteristics', 'Efficacy Evaluation'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Difficult to treat Crohn's disease (DTT-CD) was defined by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) in 2023, which refers to CD patients with poor response to drug treatment and poor prognosis. Foreign epidemiological studies have shown that DTT-CD accounts for 24.8% of all CD patients, and most of them are patients with advanced treatment failure according to more than two different mechanisms. Our previous retrospective data suggested that compared with foreign DTT-CD patients, there was no significant difference in the proportion of patients with advanced treatment failure due to more than two different mechanisms, but the proportion of patients with recurrence after two intestinal resection and complex anal fistula was increased. Therefore, this project aims to determine the current prevalence and epidemiological status of DTT-CD in China; To clarify the difference in efficacy and prognosis between DTT-CD patients and non DTT-CD patients using advanced treatment (including biological agents and small molecule drugs); Objective to evaluate the incidence and risk factors of non DTT-CD patients progressing to DTT-CD within 1 year. To further verify whether the domestic DTT-CD population is significantly different from the foreign population, and provide theoretical support for the selection of subsequent treatment options."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease who visited tertiary hospitals, including those newly diagnosed and those previously diagnosed.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The diagnosis of Crohn's disease was confirmed;\n* Patients aged 18-65;\n* Informed consent was obtained voluntarily.\n\nExclusion Criteria:\n\n* The diagnosis of CD was unclear;\n* The clinical baseline data were missing seriously;\n* Patients currently enrolled in clinical trials or receiving experimental drugs;\n* Other contraindications to biologics or small molecule drugs (including active infection, pregnancy, etc.);\n* Patients with short bowel syndrome;\n* Patients with a small bowel or colostomy."}, 'identificationModule': {'nctId': 'NCT07364734', 'briefTitle': "Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': "Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study", 'orgStudyIdInfo': {'id': '2025-ZSLYEC-556'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total study population', 'description': 'The total study population included all CD patients who visited the Sixth Affiliated Hospital of Sun Yat sen University during the specified time period (November 2025 to January 2026), including newly diagnosed and previously diagnosed patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510655', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Gao', 'role': 'CONTACT', 'email': 'gxiang@mail.sysu.edu.cn', 'phone': '+86-020-38663423'}], 'facility': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiang Gao', 'role': 'CONTACT', 'email': 'gxiang@mail.sysu.edu.cn', 'phone': '+86-020-38663423'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiang Gao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Gastroenterology', 'investigatorFullName': 'Xiang Gao', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}