Trial · NCT04089345
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
NCT04089345, Phase 3, Completed, Universitaire Ziekenhuizen KU Leuven
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stelara fOr ChRonic AntibioTic rEfractory pouchitiS. Trials, record NCT04089345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04089345
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
- NCT number
- NCT04089345
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Pouchitis
- Interventions
- Ustekinumab
- First posted
- 2019-09-13
- Last updated
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The percentage of subjects achieving clinically relevant steroid-free remission | 16 weeks after baseline | mPDAI score \<5 and a reduction by ≥2 points from baseline |
| Secondary | The percentage of subjects achieving clinically relevant steroid-free remission | 48 weeks after baseline | mPDAI score \<5 and a reduction by ≥2 points from baseline, without need for steroids |
| Secondary | The percentage of subjects achieving partial response | 16 weeks after baseline | reduction of mPDAI score by ≥2 points from baseline |
| Secondary | The percentage of subjects achieving partial response | 48 weeks after baseline | reduction of mPDAI score by ≥2 points from baseline |
| Secondary | Time to clinically relevant remission | Within 48 weeks after baseline | Time to mPDAI score \<5 and a reduction by ≥2 points from baseline |
| Secondary | Change in mPDAI endoscopic subscore | At Week 16 and 48 compared to baseline | Change in mPDAI endoscopic subscore from baseline |
| Secondary | Change in mPDAI symptomatic subscore | At Week 16 and 48 compared to baseline | Change in mPDAI symptomatic subscore from baseline |
| Secondary | Change in total mPDAI score | At Week 16 and 48 compared to baseline | Change in total mPDAI score from baseline |
| Secondary | Change in European Quality of Life 5 Dimensions (EQ-5D) | At Week 16, 32 and 48 compared to baseline | Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline |
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 |
|---|---|
| 38750870 | 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/NCT04089345
GET https://conductscience.org/api/trials/v1/NCT04089345/registered