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NCT04923100
Therapeutic Effect of New Biologics in Crohn's Disease
trial in Inflammatory Bowel Diseases in 50 participants. Status unknown.
29 March 2024
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 10 June 2021 |
| Primary completion | 29 March 2024 |
| Estimated completion | 29 March 2025 |
| Sites | 1 location across China |
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Treatment Side Effects — all drugs for Treatment Side Effects →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 17 to 80, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study.
Yao JY, Zhang M, Wang W, Peng X, et al · · 2021 · cited 27× · PMID 34663208 · DOI 10.1186/s12876-021-01946-8 -
Ustekinumab Promotes Radiological Fistula Healing in Perianal Fistulizing Crohn's Disease: A Retrospective Real-World Analysis.
Yao J, Zhang H, Su T, Peng X, et al · · 2023 · cited 18× · PMID 36769587 · DOI 10.3390/jcm12030939 -
Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease.
Yao J, Peng X, Zhong Y, Su T, et al · · 2023 · cited 3× · PMID 37554510 · DOI 10.3389/fmed.2023.1105981
Verify or expand the search:
- PubMed search for NCT04923100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Inflammatory Bowel Diseases
Currently open trials in the same condition.
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- NCT07349472 — Pentoxifylline in Patients With Ulcerative Colitis · Phase 2 · recruiting
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- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06453317 — Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis · Phase 2 · 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 NCT04923100 (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: 5 December 2023
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/NCT04923100.
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