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NCT04990245: APOLLO
pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis
trial testing endoscopic biopsies in Ulcerative Colitis in 86 participants. Completed in 28 July 2021.
28 July 2021
Quick facts
| Lead sponsor | Imelda GI Clinical Research Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 86 |
| Start date | 1 July 2020 |
| Primary completion | 28 July 2021 |
| Estimated completion | 28 July 2021 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- endoscopic biopsies
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Imelda GI Clinical Research Center
Who can join
16 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background and rationale: In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized. Objectives and design: To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04990245
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
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- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Imelda GI Clinical Research Center trials
Trials by the same sponsor.
- NCT07159776 — Multiple Digital Biomarkers for Optimization of IBD Care · not yet recruiting
- NCT04775732 — Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04990245 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Imelda GI Clinical Research Center
- Last refreshed: 4 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04990245.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing