Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)
August 30, 2011 updated by: UCB Pharma
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.
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
Study Overview
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bonheiden, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Amiens, France
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Besancon, France
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Chambray-Les-Tours, France
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Clichy, France
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Grenoble, France
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Lille, France
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Marseille, France
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Nice, France
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Paris, France
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Reims, France
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Rouen, France
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Strasbourg, France
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Vandoeuvre Les Nancy, France
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Berlin, Germany
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Bonn, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg
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Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52.
Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission.
After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
Baseline, Week 10
|
|
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
|
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.
|
Baseline, Week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments
Time Frame: Week 10
|
Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
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Week 10
|
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Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments
Time Frame: Week 10
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Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
|
Week 10
|
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Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments
Time Frame: Week 54
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Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
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Week 54
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Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments
Time Frame: Week 54
|
Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
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Week 54
|
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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
|
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.
|
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 10 Using Central Blinded Assessments
Time Frame: Baseline, Week 10
|
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.
|
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 Local Non-blinded Assessments
Time Frame: Baseline, Week 54
|
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.
|
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 Central Blinded Assessments
Time Frame: Baseline, Week 54
|
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.
|
Baseline, Week 54
|
|
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
|
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.
|
Week 10
|
|
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
|
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.
|
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
|
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.
|
Week 54
|
|
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
|
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.
|
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
|
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.
|
Week 10
|
|
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
|
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.
|
Week 10
|
|
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
|
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.
|
Week 54
|
|
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
|
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.
|
Week 54
|
|
Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
Time Frame: Baseline, Week 10
|
The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes.
Scores range from 0 to 44, with higher scores indicating greater disease.
|
Baseline, Week 10
|
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Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment
Time Frame: Baseline, Week 54
|
The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes.
Scores range from 0 to 44, with higher scores indicating greater disease.
|
Baseline, Week 54
|
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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
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
Baseline, 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
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
Baseline, Week 54
|
|
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
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
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
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
Week 54
|
|
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10
Time Frame: Week 10
|
Week 10
|
|
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Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10
Time Frame: Baseline, Week 10
|
Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.
|
Baseline, Week 10
|
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Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52
Time Frame: Week 52
|
Week 52
|
|
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Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52
Time Frame: Baseline, Week 52
|
The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.
|
Baseline, Week 52
|
|
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10
Time Frame: Week 10
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
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
|
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.
|
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 Central Blinded Assessment
Time Frame: Week 10
|
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.
|
Week 10
|
|
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
|
The histological Crohn's disease score combines active inflammatory changes: infiltration of mononuclear cells, polymorphonuclear cells, presence of erosions and/or ulcers, and chronic architectural changes.
Scores range from 0 to 44, with higher scores indicating greater disease
|
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
|
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.
|
Baseline, Week 54
|
|
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
|
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.
|
Baseline, Week 54
|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10
Time Frame: Baseline, Week 10
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
Baseline, Week 10
|
|
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54
Time Frame: Baseline, Week 54
|
Crohn's disease activity index (CDAI) responders are patients achieving clinical response (a reduction in CDAI score of at least 100 points from Baseline).
CDAI is used to quantify the symptoms of Crohn's disease.
A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
|
Baseline, Week 54
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 27, 2006
First Submitted That Met QC Criteria
February 27, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
August 31, 2011
Last Update Submitted That Met QC Criteria
August 30, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C87043
- EudraCT Number 2005-003977-25 (Other Identifier: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.