Evaluation of autonomy and care experience in multiple sclerosis when initiating subcutaneous ocrelizumab
| ISRCTN | ISRCTN31489759 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31489759 |
| Sponsor | Roche (France) |
| Funder | Roche France |
- Submission date
- 27/01/2026
- Registration date
- 27/01/2026
- Last edited
- 04/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Multiple sclerosis (MS) can significantly impact a patient's autonomy and quality of life. This study, called PEACE, observes patients with Relapsing-Remitting MS (RRMS) who are starting a new treatment formulation: ocrelizumab injected subcutaneously (under the skin). The main aim is to understand how this treatment affects patients' satisfaction, autonomy, and daily symptoms in a real-world setting.
Who can participate?
Patients aged 18 years and over diagnosed with RRMS in France for whom their doctor has decided to prescribe subcutaneous ocrelizumab.
What does the study involve?
Participants will follow their standard medical care. In addition, they will complete questionnaires on a smartphone or computer about their quality of life, symptoms, and treatment satisfaction before their first injection and then every 6 months for 2 years.
What are the possible benefits and risks of participating?
As this is an observational study where patients receive standard care prescribed by their doctor, there are no additional medical risks associated with the study itself. There is no direct benefit, but participation helps improve understanding of MS treatments.
Where is the study run from?
Roche (France)
When is the study starting and how long is it expected to run for?
February 2026 to February 2029
Who is funding the study?
Roche (France)
Who is the main contact?
Dr David Pau, david.pau@roche.com
Contact information
Scientific, Public
4 Cours de l'ile Seguin
Boulogne Billancourt
92100
France
 ORCID ID |
0000-0002-4680-6021 |
|---|---|
| Phone | +33 (0)6 28 77 22 28 |
| alexandre.civet@roche.com |
Public
4 Cours de l'ile Seguin
Boulogne Billancourt
92100
France
| ORCID ID |
0000-0002-5863-786X |
|---|---|
| Phone | +33 (0)6 22 08 16 49 |
| guillaume.bourel@roche.com |
Scientific
4 Cours de l'ile Seguin
Boulogne Billancourt
92650
France
| ORCID ID |
0000-0001-7664-4521 |
|---|---|
| Phone | +33 (0)673995067 |
| david.pau@roche.com |
Principal investigator
Hôpital de Hautepierre
1 place de l'hôpital, BP 426
Strasbourg
67091
France
| ORCID ID |
0000-0002-7197-7578 |
|---|---|
| Phone | +33 (0)3 88 11 67 68 |
| Jerome.DESEZE@chru-strasbourg.fr |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Patient Evaluation of Autonomy and Care Experience in multiple sclerosis when initiating ocrelizumab SC in real-world settings: the PEACE study |
| Study acronym | PEACE |
| Study objectives | The primary objective is to describe the evolution of Health-Related Quality of Life (HRQoL) in patients initiating ocrelizumab SC, specifically assessing treatment satisfaction, autonomy, symptoms, and general health state. Secondary objectives include comparing HRQoL over time, describing clinical effectiveness (disability progression, inflammatory activity), and assessing safety/tolerability in real-world conditions. |
| Ethics approval(s) |
Approved 20/01/2026, Comite de Protection des Personnes Ouest VI (CPP) (CHU Morvan, 2 avenue Foch, Bâtiment 1, Brest, 29200, France; +33 (0)230338064; cpp.ouest6@chu-brest.fr), ref: 25.03134.000445 |
| Health condition(s) or problem(s) studied | Relapsing-remitting multiple sclerosis (RRMS) |
| Intervention | Adult patients with RRMS initiating ocrelizumab SC (920 mg) as part of their routine clinical care will be observed for 24 months. Data will be collected via electronic Case Report Forms (eCRF) and Patient Reported Outcomes (ePROs). Clinical data and questionnaires are collected at baseline (Day 0) and at 6, 12, 18, and 24 months post-initiation. The study observes two cohorts: patients switching from other therapies (Cohort A) and treatment-naïve patients (Cohort B). |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ocrelizumab |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 28/02/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 750 |
| Key inclusion criteria | 1. Diagnosis of RRMS according to the 2017 or 2024 revised McDonald criteria 2. Age 18 years or older 3. Initiation of ocrelizumab SC planned by the healthcare professional (either as a switch from specific prior therapies or in treatment-naïve patients) 4. Physically and cognitively able to complete the study questionnaires and tests 5. Possession of a smartphone, tablet, or computer with an internet connection 6. Non-opposition to participation and data processing |
| Key exclusion criteria | 1. Administration of ocrelizumab SC not in accordance with the standard of care or the current Summary of Product Characteristics (SmPC). 2. Patient under guardianship or judicial protection. |
| Date of first enrolment | 09/02/2026 |
| Date of final enrolment | 01/02/2027 |
Locations
Countries of recruitment
- France
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Upon study completion and publication, qualified researchers may request access to individual patient level clinical data. Request will have to be send to: data_sharing.france@roche.com |
Editorial Notes
04/02/2026: The date of first enrolment was changed from 01/02/2026 to 09/02/2026.
27/01/2026: Study's existence confirmed by Comité de Protection des Personnes Ouest VI (CPP).
