Biologics for Stricturing Crohn's Diseases

• Sponsor: Jinling Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05645055
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

Recents researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.

Condition or Disease	Intervention/Treatment	Phase
The Efficacy of Biologics for Stricturing Crohn's Diseases	Other: treat these patients with biologics

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Patients with stricturing Crohn's diseases Patients with stricturing Crohn's diseases	Other: treat these patients with biologics; treat these patients with biologics

Outcome Measures

Primary Outcome Measures

1. clinical remission rate at 1 year [clinical remission rate at 1 year]

   clinical remission rate at 1 year (CDAI less than 150)

Secondary Outcome Measures

1. clinical remission rate at 5 year [clinical remission rate at 5 year]

   clinical remission rate at 5 year (CDAI less than 150)

2. surgical recurrence rate at 1 and 5 year [at 1 and 5 year]

   surgical recurrence : needing surgery for CD recurrence

3. endoscopic recurrence rate at 1 and 5 year [at 1 and 5 year]

   endoscopic recurrence: rutgeerts over i2b

4. quality of life of patients assessed by IBDQ [at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year]

   IBDQ

5. quality of life of patients assessed by Short form 12 [at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year]

   Short form 12

6. score of obstructive [at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year]

   range 0-6, higher means severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• patients with stricturing Crohn's diseases

• no surgical indication

• patients with asymptomatic penetrating diseases

• written consent acquired

Exclusion Criteria:

• patients with surgical indication

• patients with sympotomatic penetrating diseases

• contraindication of biologics

• anticipating other trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

• Jinling Hospital, China

Investigators

• Principal Investigator: Weiming wm Zhu, Ph.D., Jinling Hospital, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhu Weiming, Jinling Hospital, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT05645055
• Other Study ID Numbers: JinlingH20221203
• First Posted: Dec 9, 2022
• Last Update Posted: Dec 9, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease

Study Results

No Results Posted as of Dec 9, 2022