Clinical trial · Interventional
Mucosal Healing Study in Crohn's Disease (CD)
A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
NCT00297648CI-TRIAL-00005427MUSICcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn's Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Certolizumab pegol | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CDP870 400 mg
- description
- Certolizumab pegol (CDP870) 400 mg
- interventionNames
- Biological: Certolizumab pegol
Primary outcomes (2)
- measure
- Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments
- timeFrame
- Baseline, Week 10
- description
- The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.
- measure
- Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients suffering from active Crohn's disease \[Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450\] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8 * Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy Exclusion Criteria: * Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome * History of tuberculosis or positive tests for tuberculosis at screening * All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient * Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
References
Publications (2)
- DERIVEDColombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hebuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1. PMID 24184736
- DERIVEDHebuterne X, Lemann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault E, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23. PMID 22525883