Moderate to Severe Ulcerative ColitisINSURENCT04879966
A Cohort Study Comparing IFX to CS for Moderate to Severe UC
An observational study of Moderate to Severe Ulcerative Colitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Ulcerative Colitis
- What is being tested?
- Infliximab and Corticosteroid
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS
Who may be able to join
- moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
- Patients who had colonic involvement of at least 15 cm
- Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology
Who cannot join
- Patients who had previously used any TNF inhibitor
- Patients who were steroid-dependent or steriod-resistant
- Patients who had undergone subtotal colectomy or total colectomy
- Patients who had stoma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guandong
Jian Tang, 13751879964, tangjiansys@163.com
About this study
Official title: A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis
The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.
- Conditions
- Moderate to Severe Ulcerative Colitis
- Being tested
- Infliximab, Corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called IFX
Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
CorticosteroidDrug
Also called CS
Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
| Study group | Role | What they receive |
|---|---|---|
| UC cohort | the patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort Receives: Drug: Infliximab; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission
defined as a total score of ≤2 on the Mayo scale and no subscore >1; partial Mayo score ≤ 2, no individual subscore > 1
Measured: week 14
Secondary outcomes (9)
clinical response in induction phase
defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point
Measured: week 14
mucosal healing in induction phase
defined as a subscore of 0 or 1 on the Mayo endoscopic component
Measured: week 14
histological healing in induction phase
defined as Nancy index score of 0
Measured: week 14
clinical response in maintenance phase
defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point
Measured: week 52
mucosal healing in maintenance phase
defined as a subscore of 0 or 1 on the Mayo endoscopic component
Measured: week 52
histological healing in maintenance phase
defined as Nancy index score of 0
Measured: week 52
quality of life in induction phase
defined as an increase of ≥16 points in IBDQ score
Measured: week 14
quality of life in maintenance phase
defined as an increase of ≥16 points in IBDQ score
Measured: week 52
adverse events
as assessed by the incidence of adverse events
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start17 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Ulcerative ColitisStudies 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
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879966
- Sponsor's protocol ID
- 2021ZSLYEC-102
- Acronym
- INSURE
- Status last verified
- Nov 2022
- First submitted
- 6 May 2021
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04879966
- Acronym / sponsor ID
- INSURE / 2021ZSLYEC-102
- Conditions
- Moderate to Severe Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 May 2021 (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.
The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC cohort | – | Drug: Infliximab, Drug: Corticosteroidthe patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS
Key inclusion criteria (3 listed)
- moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
- Patients who had colonic involvement of at least 15 cm
- Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology
Key exclusion criteria (4 listed)
- Patients who had previously used any TNF inhibitor
- Patients who were steroid-dependent or steriod-resistant
- Patients who had undergone subtotal colectomy or total colectomy
- Patients who had stoma
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 |
|---|---|---|
| InfliximabAlso: IFXInfliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher | Drug | UC cohort |
| CorticosteroidAlso: CSCorticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher | Drug | UC cohort |
Primary outcome
clinical remission
Time frame: week 14
defined as a total score of ≤2 on the Mayo scale and no subscore >1; partial Mayo score ≤ 2, no individual subscore > 1
9 secondary outcomes
clinical response in induction phase
Time frame: week 14
mucosal healing in induction phase
Time frame: week 14
histological healing in induction phase
Time frame: week 14
clinical response in maintenance phase
Time frame: week 52
mucosal healing in maintenance phase
Time frame: week 52
histological healing in maintenance phase
Time frame: week 52
quality of life in induction phase
Time frame: week 14
quality of life in maintenance phase
Time frame: week 52
adverse events
Time frame: week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
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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. This study is not recruiting at the moment.
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 Moderate to Severe Ulcerative Colitis, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 3 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: status not confirmed, as of the sponsor's last update on 25 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission (time frame: week 14). 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 25 Nov 2022.