Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)
30. august 2011 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
89
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bonheiden, Belgien
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Brussels, Belgien
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Edegem, Belgien
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Leuven, Belgien
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Amiens, Frankrig
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Besancon, Frankrig
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Chambray-Les-Tours, Frankrig
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Clichy, Frankrig
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Grenoble, Frankrig
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Lille, Frankrig
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Marseille, Frankrig
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Nice, Frankrig
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Paris, Frankrig
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Reims, Frankrig
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Rouen, Frankrig
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Strasbourg, Frankrig
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Vandoeuvre Les Nancy, Frankrig
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Berlin, Tyskland
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Bonn, Tyskland
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments
Tidsramme: Baseline, Week 10
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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.
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Baseline, Week 10
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Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments
Tidsramme: 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.
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Baseline, Week 10
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments
Tidsramme: 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
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Week 10
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Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments
Tidsramme: 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
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Week 10
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Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: 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
|
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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 Central Blinded Assessments
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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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
Tidsramme: 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
|
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Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments
Tidsramme: 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
|
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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
Tidsramme: 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
|
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Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments
Tidsramme: 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
|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment
Tidsramme: Baseline, Week 10
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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.
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Baseline, Week 10
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Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment
Tidsramme: Baseline, Week 54
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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.
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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
Tidsramme: Baseline, Week 10
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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.
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Baseline, Week 10
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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 54
Tidsramme: 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.
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Baseline, Week 54
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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
Tidsramme: 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.
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Week 10
|
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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
Tidsramme: 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.
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Week 54
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Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10
Tidsramme: Week 10
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Week 10
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Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10
Tidsramme: Baseline, Week 10
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Ratio is calculated as the Week 10 value divided by the Baseline value for patients with data at both timepoints.
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Baseline, Week 10
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Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52
Tidsramme: Week 52
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Week 52
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Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52
Tidsramme: Baseline, Week 52
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The ratio is calculated as the Week 52 value divided by Baseline value for patients with data at both timepoints.
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Baseline, Week 52
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Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10
Tidsramme: 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
|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2006
Primær færdiggørelse (Faktiske)
1. januar 2008
Studieafslutning (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
27. februar 2006
Først indsendt, der opfyldte QC-kriterier
27. februar 2006
Først opslået (Skøn)
28. februar 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. august 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2011
Sidst verificeret
1. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C87043
- EudraCT Number 2005-003977-25 (Anden identifikator: EudraCT)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .