Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)
30 agosto 2011 aggiornato da: 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.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
89
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bonheiden, Belgio
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Brussels, Belgio
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Edegem, Belgio
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Leuven, Belgio
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Amiens, Francia
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Besancon, Francia
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Chambray-Les-Tours, Francia
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Clichy, Francia
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Grenoble, Francia
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Lille, Francia
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Marseille, Francia
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Nice, Francia
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Paris, Francia
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Reims, Francia
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Rouen, Francia
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Strasbourg, Francia
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Vandoeuvre Les Nancy, Francia
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Berlin, Germania
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Bonn, Germania
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: CDP870 400 mg
Certolizumab pegol (CDP870) 400 mg
|
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments
Lasso di tempo: 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
Lasso di tempo: 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 54 Using Local Non-blinded Assessments
Lasso di tempo: Week 54
|
Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
|
Week 54
|
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Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments
Lasso di tempo: Week 54
|
Mucosal healing is defined as complete absence of ulceration contribution in the CDEIS (Crohn's Disease Endoscopic Index of Severity) score
|
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 Local Non-blinded Assessments
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10
Lasso di tempo: Week 10
|
Week 10
|
|
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Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10
Lasso di tempo: 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
|
|
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52
Lasso di tempo: Week 52
|
Week 52
|
|
|
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2006
Completamento primario (Effettivo)
1 gennaio 2008
Completamento dello studio (Effettivo)
1 dicembre 2009
Date di iscrizione allo studio
Primo inviato
27 febbraio 2006
Primo inviato che soddisfa i criteri di controllo qualità
27 febbraio 2006
Primo Inserito (Stima)
28 febbraio 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
31 agosto 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 agosto 2011
Ultimo verificato
1 febbraio 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C87043
- EudraCT Number 2005-003977-25 (Altro identificatore: EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .