Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Es handelt sich hier um eine randomisierte, doppelblinde, placebokontrollierte Studie.
Randomisiert bedeutet, dass die Studienbehandlung per Zufall gewählt wird – etwa wie beim Werfen einer Münze. Im ersten Teil der Studie (die ersten 11 Wochen) ist die Wahrscheinlichkeit, Filgotinib 200 mg zu erhalten, 1 von 3 (ungefähr 33 %), die Wahrscheinlichkeit, Filgotinib 100 mg zu erhalten, 1 von 3 (ungefähr 33 %), die Wahrscheinlichkeit, Placebo zu erhalten, 1 von 3 (ungefähr 33 %).
Basierend auf den Untersuchungsergebnissen in Woche 10 werden Patienten entweder für den zweiten Teil der Studie erneut randomisiert oder sie erhalten die Möglichkeit, an einer separaten langfristigen Verlängerungsstudie teilzunehmen, wenn sie dafür geeignet sind.
Im zweiten Teil der Studie werden Patienten erneut randomisiert. Die Wahrscheinlichkeit, die bisherige Behandlung fortzusetzen, ist 2 von 3 (etwa 66 %), und die Wahrscheinlichkeit, Placebo ("Zuckerpille") zu erhalten, ist 1 von 3 (etwa 33 %). Patienten, die in den ersten 11 Wochen Placebo erhalten haben und deren Symptome oder Ergebnisse einer Darmspiegelung besser sind, erhalten weiterhin Placebo.
Doppelblind bedeutet, dass weder der Patient noch der Prüfarzt wissen werden, welches Studienmedikament der Patient nimmt. Placebokontrolliert bedeutet, dass Patienten eventuell eine Tablette einnehmen, die keinen Wirkstoff enthält, aber wie Filgotinib aussieht.
Die Teilnahme an dieser Studie wird etwa 58 Wochen dauern, der Voruntersuchungstermin oder der Besuchstermin nach Behandlungsende (30 Tage nach der letzten Dosis) nicht eingeschlossen.
In dieser Zeit müssen Patienten das Prüfzentrum mindestens 13-mal aufsuchen. Frauen im gebärfähigen Alter müssen das Prüfzentrum mindestens 19-mal aufsuchen.
Malattie studiate(Fonte di dati: BASEC)
Morbus Crohn
Health conditions
(Fonte di dati: WHO)
Crohn's Disease
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Im ersten Teil der Studie:
• Behandlung 1: Filgotinib 200 mg täglich
• Behandlung 2: Filgotinib 100 mg täglich
• Behandlung 3: Placebo täglich
Im zweiten Teil der Studie:
• Patienten die in den ersten 11 Wochen in Behandlung 1 waren, setzen entweder Behandlung 1 fort oder werden Behandlung 3 zugewiesen
• Patienten die in den ersten 11 Wochen in Behandlung 2 waren, setzen entweder Behandlung 2 fort oder werden Behandlung 3 zugewiesen
• Patienten die in den ersten 11 Wochen in Behandlung 3 waren, setzen Behandlung 3 fort
Interventions
(Fonte di dati: WHO)
Drug: Filgotinib;Drug: Placebo to match filgotinib
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Erwachsene Patienten mit mässig bis stark aktivem Morbus Crohn
Männliche Probanden und Frauen im gebärfähigen Alter, die sich im heterosexuellen
Geschlechtsverkehr engagieren, müssen einverstanden sein, die Verhütungsmethoden, wie im Protokoll beschrieben, zu verwenden.
Criteri di esclusione
(Fonte di dati: BASEC)
Colitis ulcerosa, unbestimmte Colitis, ischämische Colitis, fulminante Colitis, toxisches Megakolon
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Key Inclusion Criteria:
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on
the date of the screening visit
- Documented diagnosis of CD with a minimum disease duration of 3 months with
involvement of the ileum and/or colon at a minimum, as determined by histopathology
and endoscopic assessment
- Moderately to severely active CD
- Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response,
loss of response to, or intolerance to at least 1 of the following agents (depending
on current country treatment recommendations/guidelines): corticosteroids and
immunomodulators
- Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines) or discontinuation
of use of at least one of the following agents for reasons other than inadequate
clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa)
antagonists, vedolizumab, and ustekinumab
- Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical
response, loss of response to, or intolerance to at least 1 of the following agents
(depending on current country treatment recommendations/guidelines): TNFa antagonists,
vedolizumab, and ustekinumab
Key Exclusion Criteria:
- Current complications of CD such as symptomatic strictures, severe rectal/anal
stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
colitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any prohibited concomitant medications as described in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
22 set 2016
Inserimento del primo partecipante
31 ott 2016
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10;Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10;Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58
Punti finali secondari
(Fonte di dati: WHO)
Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10;Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10;Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845;Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58;Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI;Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by CDAI at Week 58;Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2;Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58;Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Berna
Paesi di esecuzione
(Fonte di dati: WHO)
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Prof. Frank Seibold
+41 31 302 32 34
bern@magendarmsuisse.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Gilead Study Director
Gilead Sciences
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Gilead Study Director
Gilead Sciences
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
02.05.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-02164
Secondary ID (Fonte di dati: WHO)
2016-001367-36
GS-US-419-3895
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