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NCT03885713: BioIBD
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
Phase 4 trial testing Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib in Inflammatory Bowel Diseases in 180 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 10 September 2019 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 21 locations across Spain |
Drugs / interventions tested
- Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab or tofacitinib — full drug profile →
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 →
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Who can join
18 and older, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective, multicentre trial which the biologic treatment will be initiated by clinical indication. The treatment selection anti-TNFα (infliximab, adalimumab or golimumab), vedolizumab, ustekinumab and tofacitinib will be made at the discretion of the clinician. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The IL23-IL17 Immune Axis in the Treatment of Ulcerative Colitis: Successes, Defeats, and Ongoing Challenges.
Noviello D, Mager R, Roda G, Borroni RG, et al · · 2021 · cited 105× · PMID 34079536 · DOI 10.3389/fimmu.2021.611256 -
Adverse Events Associated With Anti-IL-23 Agents: Clinical Evidence and Possible Mechanisms.
Ru Y, Ding X, Luo Y, Li H, et al · · 2021 · cited 21× · PMID 34177909 · DOI 10.3389/fimmu.2021.670398 -
Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463 -
Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis.
Zhou J, Xi Y, Zhang Y, Zhang R, et al · · 2025 · PMID 40235538 · DOI 10.3389/fphar.2025.1570238
Verify or expand the search:
- PubMed search for NCT03885713
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT03885713 (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 Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Last refreshed: 17 March 2025
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/NCT03885713.
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