The Efficacy of Biologics for Stricturing Crohn's DiseasesNCT05645055
Biologics for Stricturing Crohn's Diseases
An observational study of The Efficacy of Biologics for Stricturing Crohn's Diseases, run by Jinling Hospital, China at 1 site in China.
Trial summary
Recent 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- The Efficacy of Biologics for Stricturing Crohn's Diseases
- What is being tested?
- treat these patients with biologics
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: 200
Who may be able to join
- patients with stricturing Crohn's diseases
- no surgical indication
- patients with asymptomatic penetrating diseases
- written consent acquired
Who cannot join
- patients with surgical indication
- patients with symptomatic penetrating diseases
- contraindication of biologics
- anticipating other trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Weiming Zhu, PhD, 86-25-80863736, juwiming@126.com
About this study
Official title: The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Recent 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.
- Being tested
- treat these patients with biologics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treat these patients with biologicsOther
treat these patients with biologics
| Study group | Role | What they receive |
|---|---|---|
| Patients with stricturing Crohn's diseases | Patients with stricturing Crohn's diseases Receives: Other: treat these patients with biologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission rate at 1 year
clinical remission rate at 1 year (CDAI less than 150)
Measured: clinical remission rate at 1 year
Secondary outcomes (6)
clinical remission rate at 5 year
clinical remission rate at 5 year (CDAI less than 150)
Measured: clinical remission rate at 5 year
surgical recurrence rate at 1 and 5 year
surgical recurrence : needing surgery for CD recurrence
Measured: at 1 and 5 year
endoscopic recurrence rate at 1 and 5 year
endoscopic recurrence: rutgeerts over i2b
Measured: at 1 and 5 year
quality of life of patients assessed by IBDQ
IBDQ
Measured: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
quality of life of patients assessed by Short form 12
Short form 12
Measured: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
score of obstructive
range 0-6, higher means severe
Measured: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Efficacy of Biologics for Stricturing Crohn's DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
- Investigators
- Weiming wm Zhu, Ph.D., Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645055
- Sponsor's protocol ID
- JinlingH20221203
- Status last verified
- May 2023
- First submitted
- 2 Dec 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
- ClinicalTrials.gov ID
- NCT05645055
- Acronym / sponsor ID
- JinlingH20221203
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stricturing Crohn's diseases | – | Other: treat these patients with biologicsPatients with stricturing Crohn's diseases |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 200
Key inclusion criteria (4 listed)
- patients with stricturing Crohn's diseases
- no surgical indication
- patients with asymptomatic penetrating diseases
- written consent acquired
Key exclusion criteria (4 listed)
- patients with surgical indication
- patients with symptomatic penetrating diseases
- contraindication of biologics
- anticipating other trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treat these patients with biologicstreat these patients with biologics | Other | Patients with stricturing Crohn's diseases |
Primary outcome
clinical remission rate at 1 year
Time frame: clinical remission rate at 1 year
clinical remission rate at 1 year (CDAI less than 150)
6 secondary outcomes
clinical remission rate at 5 year
Time frame: clinical remission rate at 5 year
surgical recurrence rate at 1 and 5 year
Time frame: at 1 and 5 year
endoscopic recurrence rate at 1 and 5 year
Time frame: at 1 and 5 year
quality of life of patients assessed by IBDQ
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
quality of life of patients assessed by Short form 12
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
score of obstructive
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weiming wm Zhu, Ph.D. principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Efficacy of Biologics for Stricturing Crohn's Diseases, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiming wm Zhu, Ph.D. (+86-025-80863736 ext. 860736, juwiming@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission rate at 1 year (time frame: clinical remission rate at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.