Brief description of trial (Data source: BASEC)
ies ist eine offene Verlängerungs- und Sicherheits-beobachtungsstudie für infrage kommende Patienten, die an Studie GA29144 teilgenommen haben. Die Patienten können in einen oder beide Teile der Studie aufgenommen werden.
Diese offene Verlängerungs- und Sicherheitsbeobachtungsstudie (open-label extension safety monitoring, OLE-SM) besteht aus zwei Teilen.
In Teil 1 (OLE) dieser Studie sollen die langfristige Sicherheit und Verträglichkeit von 105 mg s.c. Etrolizumab alle vier Wochen hinsichtlich unerwünschter Ereignisse und auffälliger Laborwerte bewertet sowie Langzeitdaten zur Wirksamkeit und Immunogenität erhoben werden. Patienten, die in der Studie GA29144 Etrolizumab oder Placebo erhalten, sind möglicherweise für die Teilnahme geeignet und erhalten in Teil 1 (OLE) dieser Studie Etrolizumab.
In Teil 2 (SM) dieser Studie sollen Patienten, die Etrolizumab abgesetzt haben, auf PML hin überwacht werden. Patienten, die Teil 1 (OLE) dieser Studie verlassen, treten anschliessend in Teil 2 (SM) dieser Studie zur Überwachung hinsichtlich PML-Ereignissen ein. Ausserdem werden alle Patienten aus der Studie GA29144, die nicht für eine Fortsetzung der Behandlung mit Etrolizumab in Teil 1 (OLE) dieser Studie aufgenommen wurden, direkt in Teil 2 (SM) dieser Studie aufgenommen, um sie einer ausgedehnten PML-Sicherheitsüberwachung zu unterziehen (nach Abschluss der 12-wöchigen Sicherheitsnachbeobachtung in Studie GA29144).
Health conditions investigated(Data source: BASEC)
Mittelschwerer bis schwerer aktiver Morbus Crohn
Health conditions
(Data source: WHO)
Crohn Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Etroluzimab, alle 4 Wochen subkutan injiziiert
Interventions
(Data source: WHO)
Drug: Etrolizumab
Criteria for participation in trial
(Data source: BASEC)
Teil 1 (OLE):
Patienten, die an Studie GA29144 teilgenommen haben und Krankheitsverschlechterung gem. CDAI- und PRO2-Scores haben.
Teil 2 (SM):
Patienten, die nicht für Teil 1 in Frage kommen
Exclusion criteria
(Data source: BASEC)
Teil 1 (OLE):
Patienten, die vor Woche 10 aus der Studie GA29144 ausscheiden
Teil 2 (SM):
Keine
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
Part 1 Open-Label Extension:
- Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who
meet the eligibility criteria for open-label etrolizumab as described in the protocol
Part 2 Safety Monitoring:
- Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are
not eligible or choose not to enter Part 1
- Patients who transfer from Part 1
- Completion of the 12-week safety follow-up period prior to entering
Exclusion Criteria:
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
-
Further information on trial
Recruitment status
Terminated
Academic title
(Data source: WHO)
An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time;Part 1: Number of Participants with Clinical Remission Over Time;Part 1: Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 108;Part 1: Overall Number of Participants who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0);Part 1: Overall Number of Participants with Adverse Events Leading to Etrolizumab Discontinuation;Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Adverse Event by Severity, According to NCI-CTCAE v4.0;Part 1: Number of Infection-Related Adverse Events per Patient-Year;Part 1: Overall Number of Participants who Experienced at Least One Infection-Related Serious Adverse Event;Part 1: Overall Number of Participants who Experienced at Least One Injection-Site Reaction by Severity, According to NCI-CTCAE v4.0;Part 1: Overall Number of Participants who Develop Malignancies;Part 1: Number of Malignancies per Patient-Year;Part 1: Overall Number of Participants who Experienced at Least One Hypersensitivity Reaction by Severity, According to NCI-CTCAE v4.0;Part 1: Number of Participants with Anti-Therapeutic Antibodies (ATAs) to Etrolizumab;Part 2: Number of Participants who Experienced at Least One Suspected or Confirmed Event of Progressive Multifocal Leukoencephalopathy (PML)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern, St. Gallen, Zurich
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Republic of, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof. Dr. Jan Borovicka
0041 71 494 2646
jan.borovicka@kssg.ch
Contact for general information
(Data source: WHO)
Clinical Trials
Hoffmann-La Roche
Contact for scientific information
(Data source: WHO)
Clinical Trials
Hoffmann-La Roche
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Ostschweiz (EKOS)
Date of authorisation by the ethics committee
29.07.2016
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-00491
Secondary ID (Data source: WHO)
2014-003855-76
GA29145
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