OCRELIZUMAB for Progressive multiple sclerosis | Primary progressive multiple sclerosis | Secondary progressive multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)\n- EDSS (Expanded Disability Status Scale) </ =6.5 at screening\n- Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment\n- Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist\n- Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers\n- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug"}

Exclusion criteria

• {"criterion_text":"- Relapsing-remitting multiple sclerosis (RRMS) at screening\n- Inability to complete an MRI\n- Gadolinium (Gd) intolerance\n- Known presence of other neurological disorders\n- Positive screening tests for hepatitis B\n- Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or"}

Primary endpoints

• {"endpoint_text":"- 1. Proportion of patients with no evidence of progression (NEP) sustained for at least 24 weeks","definition_or_measurement_approach":"Defined in translations as absence of progression maintained for at least 24 weeks (no evidence of progression, NEP, sustained for ≥24 weeks)."}
• {"endpoint_text":"- 2. Proportion of patients with NEP and no active disease (NEPAD) sustained for at least 24 weeks","definition_or_measurement_approach":"Defined in translations as NEP combined with no active disease (NEPAD) sustained for at least 24 weeks."}

Secondary endpoints

• {"endpoint_text":"- 1. Change from baseline in cognitive function as measured by the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test – Revised (BVMT-R)","definition_or_measurement_approach":"Change from baseline measured using SDMT and BVMT-R scores."}
• {"endpoint_text":"- 2. Change from baseline in the patient-reported outcomes including Multiple Sclerosis Impact Scale -29, Multiple Sclerosis Walking scale -12 items, ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive (FSMC) function, SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale, Numerical Pain Rating Scale, Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive functions","definition_or_measurement_approach":"Change from baseline in listed patient-reported outcome instruments."}
• {"endpoint_text":"- 3. Mean change from baseline in the EDSS score over the course of the study","definition_or_measurement_approach":"Mean change from baseline using EDSS (Expanded Disability Status Scale) assessments."}
• {"endpoint_text":"- 4. Time to onset of first confirmed disability progression (as measured by EDSS) sustained for at least 24 and 48 weeks","definition_or_measurement_approach":"Time-to-event measured as time to first confirmed disability progression by EDSS sustained for ≥24 and ≥48 weeks."}
• {"endpoint_text":"- 5. Time to onset of first >=20% increase in timed 25-foot walk test sustained for at least 24 weeks","definition_or_measurement_approach":"Time-to-event for first ≥20% worsening in T25FW sustained for ≥24 weeks."}
• {"endpoint_text":"- 6. Time to onset of first >=20% increase in 9-hole peg test sustained for at least 24 weeks","definition_or_measurement_approach":"Time-to-event for first ≥20% worsening in 9-HPT sustained for ≥24 weeks."}
• {"endpoint_text":"- 7. Proportion of patients with NEP","definition_or_measurement_approach":"Proportion of patients meeting NEP criteria during assessment windows."}
• {"endpoint_text":"- 8. Proportion of patients with NEPAD","definition_or_measurement_approach":"Proportion of patients meeting NEPAD criteria."}
• {"endpoint_text":"- 9. Proportion of patients with confirmed disability improvement (CDI) sustained for at least 24 weeks","definition_or_measurement_approach":"Proportion with CDI defined as improvement sustained for ≥24 weeks."}
• {"endpoint_text":"- 10. Change in the following MRI volumetric measures: whole brain volume, cerebral white matter volume change, cortical gray matter volume, deep grey matter volume, thalamic volumes, whole and regional cerebellar volume","definition_or_measurement_approach":"Change from baseline in listed MRI volumetric measures."}
• {"endpoint_text":"- 11. Change in the following lesion and tissue integrity parameters: - Number of new/enlarging T2 lesions and total T2 lesion volume - Number of T1 Gd+ lesions and total volume - Number of T1 lesions and total volume - Gd-enhancing fluid-attenuated inversion-recovery (FLAIR) meningeal lesions","definition_or_measurement_approach":"MRI lesion counts and volumes as listed, including Gd+ T1 lesions and FLAIR meningeal lesions."}
• {"endpoint_text":"- 12. Rate and nature of adverse events","definition_or_measurement_approach":"Collection and summary of adverse events (incidence and type)."}
• {"endpoint_text":"- 13. Changes in clinical laboratory results","definition_or_measurement_approach":"Change from baseline in clinical laboratory parameters."}
• {"endpoint_text":"- 14. Rates of study treatment discontinuation due to adverse events","definition_or_measurement_approach":"Proportion discontinuing study treatment because of adverse events."}
• {"endpoint_text":"- 15. Change in the number of falls and near-falls","definition_or_measurement_approach":"Change from baseline in number of falls and near-falls reported."}

Netherlands

Latest Decision Or Authorization Date

06-05-2025

Number Of Sites

1

Number Of Participants

37

Germany

Latest Decision Or Authorization Date

09-05-2025

Number Of Sites

6

Number Of Participants

53

Denmark

Latest Decision Or Authorization Date

12-05-2025

Number Of Sites

3

Number Of Participants

45

Czechia

Latest Decision Or Authorization Date

07-05-2025

Number Of Sites

2

Number Of Participants

36

France

Latest Decision Or Authorization Date

25-08-2025

Number Of Sites

10

Number Of Participants

171

Italy

Latest Decision Or Authorization Date

21-07-2025

Number Of Sites

5

Number Of Participants

125

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Global CRO

Name

Pharmaceutical Product Development LLC

Responsibilities

code 4

Name

Cytel Inc.

Responsibilities

code 10

Third parties

• {"country":"Italy","full_name":"Neuroquantic S.r.l.s.","duties_or_roles":"Central Reader MEP","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"RHBB Psychology Neuropsychology PLLC","duties_or_roles":"Central Reader BICAMS","organisation_type":"Health care"}
• {"country":"United States","full_name":"Cellular Technology Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"code 10","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"University Of California San Francisco","duties_or_roles":"Imaging Vendor","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"University College London","duties_or_roles":"Imaging Vendor","organisation_type":"Educational Institution"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"The Università degli Studi di Genova - Dipartimento di Scienze della Salute","duties_or_roles":"code 10; Integrated iGlove/clinical/MRI data analysis","organisation_type":"Health care"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Thomas Jefferson University","duties_or_roles":"Central Reader OCT/VA","organisation_type":"Educational Institution"}
• {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Imaging Vendor","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}