A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2017-004886-29-IE
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial
• Scientific title: A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL
• Date of first enrolment: 11/01/2019
• Target sample size: 1127
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004886-29
• 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: no 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, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, Czechia, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom

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:
- Able to comply with the study protocol, in the investigator’s judgment
- Completed the treatment period of Roche sponsored ocrelizumab Parent-trial (including the female patients who were pregnant during the parent studies and are still in the safety follow up period) and who in the opinion of the investigator may benefit from treatment with ocrelizumab and so are eligible for ocrelizumab re-treatment
- Meet re-treatment criteria with ocrelizumab
- Patients who became pregnant by chance between the last visit of the parent study and screening of this study, as confirmed by pregnancy tests at screening, will enter the safety follow-up immediately and re-start the treatment after birth and breastfeeding are over, as per re-treatment criteria
- For women of childbearing potential: agreement to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the local ocrelizumab package leaflet.

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 1127
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Hypersensitivity to ocrelizumab or to any of its excipients
- Patients in a severely immunocompromised state until the condition resolves
- Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
- Existence of a contra-indication as per ocrelizumab package leaflet
- Prohibited concomitant medication use
- Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
- Patients who discontinued ocrelizumab, exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in the safety follow-up of the parent study


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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Multiple sclerosis (MS)
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1 Level: LLT Classification code 10039720 Term: Sclerosis multiple System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive name: OCRELIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: • Different effectiveness measures evaluated for ocrelizumab in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial
• To evaluate the safety and tolerability of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial

Primary end point(s): 1. Evaluate clinical measures related to disease progression over two years in MS patients

Timepoint(s) of evaluation of this end point: 1. Up to 2 years

Main Objective: • To evaluate the effectiveness of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-26. Up to 2 years

Secondary end point(s): 1. Time to onset of Confirmed disability progression (CDP) sustained for at least 24 weeks and for at least 48 weeks
2. Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the study
3. Proportion of patients who have improved, stable or worsened disability compared with baseline (inclusion in the study) measured by expanded disability status scale (EDSS)’
4. Mean change from inclusion in the study in EDSS score over the course of the study
5. Time to 20% increase in timed 25-foot walk test (T25FWT); time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end of the study
6. Time to first protocol-defined event of disease activity
7. Time to first relapse
8. Annualised relapse rate
9. Proportion of patient relapse free, yearly and over the course of the study
10. Proportion of patients with no evidence of protocol-defined disease activity (NEDA) yearly and over the course of the study
11. Proportion of patients with no evidence of progression, measured by EDSS, 9HPT and T25FW (if assessments are available)
12. Proportion of patients with no evidence of progression sustained for at least 24 weeks and no active disease (if assessments are available)
13. Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
14. Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
15. Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
16. Change in total T1 hypointense lesion volume over time
17. Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time
18. Change in brain volume (including white and grey matter fractions) as detected by brain MRI over time
19. Presence and evolution of leptomeningeal follicles
20. Time to treatment discontinuation/switch
21. Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
22. SymptoMScreen score
23. Quality of life (Multiple Sclerosis Impact Scale [MSIS]-29)
24. Evaluation of cognition as measured by SDMT assessment
25. Rate and nature of adverse events
26. Changes in vital signs, neurological examinations, clinical laboratory results, locally reviewed MRI for safety (non-MS CNS pathology) and concomitant medications

Secondary ID(s)

2017-004886-29-ES

MN39158

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 11/01/2019
Contact: