Clinical trial NCT00297648: Mucosal Healing Study in Crohn's Disease (CD)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Certolizumab pegol
Crohn's disease
Mucosal healing
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.


Eligibility criteria: 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

Primary outcomes:
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
measure: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments
timeFrame: Baseline, Week 10
Secondary outcomes:
measure: Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments
timeFrame: Week 54
measure: Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments
timeFrame: Week 54
measure: Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments
timeFrame: Baseline, Week 10
measure: Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments
timeFrame: Baseline, Week 10
measure: Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments
timeFrame: Baseline, Week 54
measure: Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments
timeFrame: Baseline, Week 54
measure: Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments
timeFrame: Week 54
measure: Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments
timeFrame: Week 54
measure: Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments
timeFrame: Week 10
measure: Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments
timeFrame: Week 54
measure: Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments
timeFrame: Week 54
measure: Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
timeFrame: Baseline, Week 10
measure: Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment
timeFrame: Baseline, Week 54
measure: Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10
timeFrame: Baseline, Week 10
measure: Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54
timeFrame: Baseline, Week 54
measure: Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10
timeFrame: Week 10
measure: Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54
timeFrame: Week 54
measure: Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10
timeFrame: Week 10
measure: Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10
timeFrame: Baseline, Week 10
measure: Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52
timeFrame: Week 52
measure: Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52
timeFrame: Baseline, Week 52
measure: Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10
timeFrame: Week 10
measure: Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment
timeFrame: Week 10
measure: Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment
timeFrame: Week 10
measure: Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
timeFrame: Week 10
measure: Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment
timeFrame: Baseline, Week 54
measure: Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment
timeFrame: Baseline, Week 54
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10
timeFrame: Baseline, Week 10
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54
timeFrame: Baseline, Week 54
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Amiens
country: France
city: Besancon
country: France
city: Chambray-Les-Tours
country: France
city: Clichy
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Marseille
country: France
city: Nice
country: France
city: Paris
country: France
city: Reims
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Vandoeuvre Les Nancy
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Colombel 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.
citation: Hebuterne 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.