Mucosal Healing Study in Crohn's Disease (CD)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00297648
• Date of registration: 27/02/2006
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Mucosal Healing Study in Crohn's Disease (CD) MUSIC
• Scientific 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 (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.
• Date of first enrolment: February 2006
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00297648
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Certolizumab pegol

Primary Outcome(s)

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments [Time Frame: Baseline, Week 10]

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments [Time Frame: Baseline, Week 10]

Secondary Outcome(s)

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 [Time Frame: Week 54]

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments [Time Frame: Week 10]

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 [Time Frame: Week 54]

Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment [Time Frame: Baseline, Week 10]

Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment [Time Frame: Baseline, Week 54]

Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10 [Time Frame: Week 10]

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 [Time Frame: Week 54]

Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment [Time Frame: Baseline, Week 54]

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 [Time Frame: Week 10]

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10 [Time Frame: Baseline, Week 10]

Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10 [Time Frame: Week 10]

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 [Time Frame: Week 54]

Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment [Time Frame: Week 10]

Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52 [Time Frame: Week 52]

Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments [Time Frame: Week 10]

Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments [Time Frame: Week 54]

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54 [Time Frame: Baseline, Week 54]

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 [Time Frame: Week 10]

Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment [Time Frame: Baseline, Week 54]

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 [Time Frame: Baseline, Week 10]

Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments [Time Frame: Week 54]

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 [Time Frame: Baseline, Week 10]

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 [Time Frame: Baseline, Week 54]

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 [Time Frame: Baseline, Week 54]

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 [Time Frame: Week 10]

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 [Time Frame: Week 10]

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 [Time Frame: Baseline, Week 10]

Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52 [Time Frame: Baseline, Week 52]

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 [Time Frame: Week 10]

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 [Time Frame: Baseline, Week 54]

Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments [Time Frame: Week 10]

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 [Time Frame: Week 10]

Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments [Time Frame: Week 54]

Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10 [Time Frame: Baseline, Week 10]

Secondary ID(s)

C87043

EudraCT Number 2005-003977-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/01/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00297648