A Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Treatment in Patients with Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and without Access to A Post Trial Access Program

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Dec 2024 → ongoing

Decision date (initial)

2025-11-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

To evaluate the physical impact of multiple sclerosis from a patient’s perspective and provide continued access to ocrelizumab

Secondary objectives 1

1. To evaluate the safety and tolerability of ocrelizumab

Conditions and MedDRA coding

Multiple Sclerosis

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Signed extension study Informed Consent Form
2. 2. Patients who were on ongoing ocrelizumab treatment on one of the following parent studies (Studies MN39159/CONSONANCE, BN42082/MUSETTE, BN42083/GAVOTTE, BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O’HAND, MN43964/OLERO, GN41791/FENTREPID, BP46016/ MINTAKA, CN41144/OCARINA I-SC, CN42097/OCARINA II-SC) at the time of roll-over and who do not have access to the ocrelizumab treatment locally
3. 3. The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study
4. 4. Ability to comply with the extension study protocol, per investigator’s judgement
5. 5. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
6. 6. Requirements for contraception and pregnancy testing For female participants of childbearing potential: : agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab Participants are considered to be of childbearing potential if they are postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements As defined by the guidelines, the following contraceptive methods are considered acceptable: (1) Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; (2) Male or female condom with or without spermicide; (3) Cap, diaphragm, or sponge with spermicide; (4) Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier method) Birth control methods that are highly effective (i.e., failure rate <1%) may also be used but are not required, and include: (1) Oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation. (2) Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation. (3) Intrauterine device. (4) Intrauterinehormone-releasing system. (5) Bilateral tubal occlusion. (6) Vasectomized partner. (7) Sexual abstinence

Exclusion criteria 6

1. 1. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient
2. 2. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient
3. 3. Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
4. 4. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
5. 5. Concurrent participation in any therapeutic clinical trial (other than the parent study)
6. 6. Hypersensitivity to the active substance

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Change from baseline to end of study in Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)
2. 2. Number of eligible participants who have received access to ocrelizumab in the study (time frame: up to 5 years)

Secondary endpoints 1

1. 1. The incidence, nature, severity and outcome of serious adverse events, adverse events leading to discontinuation, and adverse events of special interest

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 2

Locations

3 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 23 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications