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NCT04999228
Top Down Versus Step up in Pediatric Ulcerative Colitis
Phase 4 trial testing Infliximab in Ulcerative Colitis in 40 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | Children's Hospital of Fudan University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 November 2021 |
| Primary completion | 1 June 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Infliximab (infliximab) — full drug profile →
- Corticosteroids (corticosteroids) — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Infliximab — all drugs for Infliximab →
- Children — all drugs for Children →
Sponsor
Children's Hospital of Fudan University
Who can join
Adults 6 to 18, any sex, with Ulcerative Colitis or Infliximab. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04999228
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
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- 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 Children's Hospital of Fudan University trials
Trials by the same sponsor.
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- NCT07325903 — Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty · EARLY_PHASE1 · not yet recruiting
- NCT07141615 — Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of P · NA · not yet 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 NCT04999228 (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 Children's Hospital of Fudan University
- Last refreshed: 28 February 2024
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/NCT04999228.
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