Trial · NCT05542459
Multi-omics to Predict Responses to Biologics in IBD
NCT05542459, Unknown, Sixth Affiliated Hospital, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi-omics to Predict Responses to Biologics in IBD. Trials, record NCT05542459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05542459
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-omics to Predict Responses to Biologics in IBD
- NCT number
- NCT05542459
- Status
- Unknown
- Enrollment
- 1,050 participants, estimated
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Conditions
- Crohn Disease, Ulcerative Colitis
- Interventions
- Biologics
- First posted
- 2022-09-15
- Last updated
- 2022-09-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical response | At week 14-26 | The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI \<150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis |
| Primary | Mucosal healing | At week 42-64 | Mucosal healing is defined as absence of mucosal ulceration |
| Secondary | Clinical response rate with steroids or without steroids | At week 14-26 and week 42-64 | Clinical response rate with steroids or without steroids at week 14-26 and week 42-64 |
| Secondary | Clinical remission rate with steroids or without steroids | At week 14-26 and week 42-64 | Clinical remission rate with steroids or without steroids at week 14-26 and week 42-64 |
| Secondary | Objective response rate | At week 14-26 and week 42-64 | Objective response was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 |
| Secondary | Objective remission rate | At week 14-26 and week 42-64 | Objective remission was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 |
| Secondary | Inflammatory Bowel Disease Questionnaire (IBDQ) score | At baseline, week 14-26 and week 42-64 | IBDQ score at baseline, week 14-26 and week 42-64 |
| Secondary | 36-Item Short Form Health Survey (SF-36) score | At baseline, week 14-26 and week 42-64 | SF-36 score at baseline, week 14-26 and week 42-64 |
| Secondary | EQ-5D score | At baseline, week 14-26 and week 42-64 | EQ-5D score at baseline, week 14-26 and week 42-64 |
| Secondary | Incidence of adverse events | Through study completion | Incidence of adverse events through study completion |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38926732 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05542459
GET https://conductscience.org/api/trials/v1/NCT05542459/registered