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NCT04879966: INSURE
A Cohort Study Comparing IFX to CS for Moderate to Severe UC
trial testing Infliximab in Moderate to Severe Ulcerative Colitis in 342 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 342 |
| Start date | 17 May 2021 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Infliximab (infliximab) — full drug profile →
- Corticosteroid — full drug profile →
Conditions studied
- Moderate to Severe Ulcerative Colitis — all drugs for Moderate to Severe Ulcerative Colitis →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Moderate to Severe Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
- PubMed search for NCT04879966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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- NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting
Other recruiting trials for Moderate to Severe Ulcerative Colitis
Currently open trials in the same condition.
- NCT06693908 — A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Co · Phase 1, PHASE2 · recruiting
- NCT05486104 — Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis · Phase 2 · active not recruiting
Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
- NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
- NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
- NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting
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 NCT04879966 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 25 November 2022
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/NCT04879966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing