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NCT03043677
Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells
trial testing Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab in Inflammatory Bowel Disease in 45 participants. Completed in 30 May 2018.
31 December 2017
Quick facts
| Lead sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 45 |
| Start date | 1 April 2016 |
| Primary completion | 31 December 2017 |
| Estimated completion | 30 May 2018 |
Drugs / interventions tested
- Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab — full drug profile →
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Who can join
Adults 18 to 80, any sex, with Inflammatory Bowel Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To characterize circulating DC subsets from healthy controls and IBD patients and to assess, following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators on both the GI production of soluble immune mediators and the mucosal capacity to alter the recruitment capacity of circulating DC subsets. It is expected that such approach will provide further information on the action mechanisms of such therapies on IBD patients, allowing a better understanding of the pathophysiology of this disease and the identification of tissue-specific therapeutic targets, thus avoiding collateral problems associated with systemic immunomodulation.
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 NCT03043677
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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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 NCT03043677 (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 Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Last refreshed: 25 February 2019
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/NCT03043677.
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