An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies

• Register: EUCTR
• Last refreshed on: 16 October 2023
• Main ID: EUCTR2013-004435-72-NO
• Date of registration: 06/08/2014
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: An open-label extension and safety monitoring study for patients with ulcerative colitis previously enrolled in etrolizumab phase II/III studies
• Scientific title: AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE II/III STUDIES - Cottonwood
• Date of first enrolment: 17/10/2014
• Target sample size: 2100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004435-72
• 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: Open-label extension and safety monitoring study If controlled, specify comparator, Other Medicinial Product: Placebo: Other: 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, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States, Vietnam

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 Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
Part 2 (Safety Monitoring)
- Patients who participated in one of the etrolizumab Phase II OLE study or Phase III studies and are not eligible or chose not to enter Part 1 (OLE)
- Patients who transfer from Part 1 (OLE)
- Completion of the 12-week safety follow-up 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 1907
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193

Exclusion criteria:
Part 1 (Open-label Extension)
- Any new, significant, uncontrolled condition
- Receipt of the following since commencement of the Phase II OLE or Phase III controlled studies: Use of anti-adhesion molecules
Part 2 (Safety Monitoring)
- No exclusion criteria


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

Health Condition(s) or Problem(s) studied

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

Ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Intervention(s)

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
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: rhuMAb Beta7, Anti Beta7, PRO145223
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: For 1 and 4: Up to 7 years
2 and 3: at Week 108 in Part 1 (OLE)

Secondary Objective: n.a.

Primary end point(s): 1) Long-term efficacy as determined by partial Mayo Clinic Score (pMCS)
2) To evaluate remission by MCS at Week 108 in Part 1 (OLE)
3) To evaluate endoscopic remission by MCS at Week 108 in Part 1 (OLE)
4) Incidence of adverse events

Main Objective: • Part 1 (OLE): to assess the long-term safety and efficacy of etrolizumab in eligible patients.
• Part 2 (SM): Progressive multifocal leukoencephalopathy (PML) safety monitoring.

Secondary Outcome(s)

Secondary end point(s): n.a.

Timepoint(s) of evaluation of this end point: n.a.

Secondary ID(s)

GA28951

2013-004435-72-GB

NCT02118584

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 17/10/2014
Contact: