Trial · NCT07877636
Objective Disease Control and Treatment Strategies in Ulcerative Colitis
NCT07877636, Not yet recruiting, First Affiliated Hospital, Sun Yat-Sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Objective Disease Control and Treatment Strategies in Ulcerative Colitis. Trials, record NCT07877636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Objective Disease Control and Treatment Strategies in Ulcerative Colitis
- NCT number
- NCT07877636
- Status
- Not yet recruiting
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Conditions
- Ulcerative Colitis (Disorder)
- Interventions
- Routine Clinical Care
- First posted
- 2026-10-16
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Under Objective Uncontrolled Disease | Up to 36 months from the relevant index date | Time under objective uncontrolled disease (TUOD) will be defined as the cumulative proportion of evaluable follow-up time during which a participant is classified as having objectively uncontrolled ulcerative colitis according to a prespecified longitudinal disease-state algorithm. Objective inflammatory status will be reconstructed using available endoscopic assessments, fecal calprotectin, intestinal ultrasound, C-reactive protein, and other clinically appropriate objective assessments according to a predefined hierarchy and temporal assignment rules. Periods without sufficient objective information to determine inflammatory status will be classified as unknown or unobservable and will not be assumed to represent disease control. TUOD will primarily be expressed as the percentage of evaluable follow-up time classified as objectively uncontrolled. |
| Secondary | Objective Disease-Control Time | Up to 36 months from the relevant index date | The proportion of evaluable follow-up time during which a participant meets prespecified criteria for objective disease control based on available biochemical, endoscopic, imaging, and other objective disease assessments. Periods with insufficient information will be classified separately as unknown or unobservable. |
| Secondary | Time to Treatment Adaptation After Objective Disease Non-Control | Up to 12 months after first confirmed objective disease non-control | Time from the first qualifying episode of confirmed objective disease non-control to a clinically relevant treatment adaptation, including treatment optimization, addition of an eligible therapy, discontinuation, or switching to another therapeutic mechanism. |
| Secondary | Advanced-Therapy Persistence | Up to 36 months after advanced-therapy initiation | Time from initiation of an eligible advanced therapy to permanent discontinuation or switching to another advanced therapy, according to prespecified treatment-exposure rules. |
| Secondary | Ulcerative Colitis-Related Hospitalization | Up to 36 months from the relevant index date | Occurrence and time to hospitalization attributed to ulcerative colitis activity or complications during longitudinal follow-up. |
| Secondary | Colectomy | Up to 36 months from the relevant index date | Occurrence and time to colectomy related to ulcerative colitis during longitudinal follow-up. |
| Secondary | Longitudinal Disease-State Transitions | Up to 36 months from the relevant index date | Transitions between prespecified longitudinal states, including objective disease control, objective disease non-control, treatment-escalation states, hospitalization, and surgery. Transition frequencies, rates, and/or probabilities will be estimated according to the prespecified analysis plan |
| Secondary | Objective Disease-Control Time Following Confirmed Disease Non-Control | Up to 24 months after first confirmed objective disease non-control | The proportion of evaluable follow-up time spent in objective disease control after the first qualifying episode of objective disease non-control during advanced therapy. This outcome will support prespecified analyses of alternative treatment-adaptation strategies. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07877636
GET https://conductscience.org/api/trials/v1/NCT07877636/registered