An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease

• Register: EUCTR
• Last refreshed on: 3 October 2023
• Main ID: EUCTR2014-003855-76-LT
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease
• Scientific title: 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
• Date of first enrolment: 10/04/2015
• Target sample size: 1150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003855-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Extension and safety If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Part 1 Open-label Extension:
-Patients previously enrolled in etrolizumab Phase III study GA29144 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 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 in either GA29144 or GA29145, Part 1 (OLE), as applicable,-period prior to entering
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
Part 1 Open-label Extension:
-Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:
-No exclusion criteria



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn`s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04-02
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Etrolizumab
CAS Number: 1044758-60-2
Current Sponsor code: RO5490261
Other descriptive name: ETROLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-

Primary Outcome(s)

Main Objective: The objectives of this open-label extension-safety monitoring (OLE-SM) study are as follows:
Part 1 (Open-Label Extension; OLE)
• To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)
Part 2 (Safety Monitoring; SM)
• Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment

Safety Objectives
The other safety objectives for this study are as follows:
Part 1 (OLE)
• To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events
• To evaluate the incidence and rate per subject-year of malignancies
• To evaluate the incidence and severity of hypersensitivity reactions
• To evaluate the incidence and the clinical significance of anti-therapeutic antibodies (ATAs)

Primary end point(s): The efficacy outcome measures:
• CDAI remission assessed at 12-week intervals during Part 1 (OLE)
• Clinical remission assessed at 12-week intervals during Part 1 (OLE)
• Simplified Endoscopic Index for Crohn’s disease (SES-CD) score assessed at Week 108 or at early withdrawal, if prior to Week 108, during Part 1 (OLE)

Safety Outcome Measures
Part 1 (OLE)
• Incidence and severity of adverse events
• Incidence of serious adverse events
• Incidence, rate per subject-year, and severity of infection-related adverse events
• Incidence of serious infection-related adverse events
• Incidence and severity of injection-site reactions
• Incidence of adverse events leading to etrolizumab discontinuation
• Incidence of laboratory abnormalities
• Incidence and rate per subject-year of malignancies
• Incidence of ATAs to etrolizumab
• Incidence and severity of hypersensitivity reaction events

Part 2 (SM)
• Incidence of suspected or confirmed PML events

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: • CDAI remission assessed at 12-week
• Clinical remission assessed at 12-week
The CDAI and Clinical scores will be calculated, and the APQ (Abdominal Pain Questionnaire) will be completed every 12 weeks and at Study Completion
• SES-CD at 108 weeks or at early withdrawal

Safety Outcome Measures (Part 1 and 2)
• Weeks, 0, 4, 8, 12 and then every 12 weeks thereafter

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

2014-003855-76-SE

GA29145

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 19/03/2015
Contact: