A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

• Register: ClinicalTrials.gov
• Last refreshed on: 24 January 2022
• Main ID: NCT03589105
• Date of registration: 05/07/2018
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting PRO-MSACTIVE
• Scientific title: An Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple Sclerosis
• Date of first enrolment: August 6, 2018
• Target sample size: 423
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03589105
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age >/=18 years at screening

- Patients with relapsing forms of multiple sclerosis (RMS) with active disease defined
by clinical or imaging features: (i) at least one clinical relapse over a 6-month
period prior to screening; (ii) AND/OR at least one T1 gadolinium-enhancing lesion or
new and/or enlarging T2 lesion as detected by brain Magnetic Resonance Imaging (MRI)
performed over a 3 months period prior to screening with no change of
Disease-Modifying Treatment(s) (DMT) compared to a previous MRI performed within 24
months before screening

- For women of childbearing potential: agreement to use an acceptable birth control
method during the treatment period and for at least 12 months after the last dose of
ocrelizumab

- Participants should be beneficiary of healthcare coverage under the social security
system

Exclusion Criteria:

- Diagnosis of primary progressive MS

- Inability to complete an MRI (contraindications for MRI include but are not restricted
to weight =140 kg, pacemaker, cochlear implants, presence of foreign substances in the
eye, intracranial vascular clips, surgery within 6 weeks of entry into the study,
coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc…)

- Gadolinium intolerance

- History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic
attack) or ischemia of the spinal cord

- History or known presence of central nervous system (CNS) or spinal cord tumor (e.g.,
meningioma, glioma)

- History or known presence of potential metabolic causes of myelopathy (e.g., untreated
vitamin B12 deficiency)

- History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme
disease, human T-lymphotropic virus 1 (HTLV-1), herpes zoster myelopathy)

- History of genetically inherited progressive CNS degenerative disorder (e.g.,
hereditary paraparesis; MELAS [mitochondrial myopathy, encephalopathy, lactic
acidosis, stroke] syndrome)

- Neuromyelitis optica

- History or known presence of systemic autoimmune disorders potentially causing
progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome,
Sjogren's syndrome, Behçet's disease, sarcoidosis)

- History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral
contusion, spinal cord compression)

- Vulnerable patients (Patient referred to in Articles L. 1121-5 to L. 1121-8 and L.
1122-1-2 of the French Public Health Code)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab 300 mg

Drug: Ocrelizumab 600 mg

Primary Outcome(s)

Percentage of participants free of disease activity [Time Frame: From Enrollment to Week 48]

Secondary Outcome(s)

Change in the score of EuroQol 5-Dimension Questionnaire (EQ-5D-5L with Visual Analogue Scale (VAS)) for health-related quality of life [Time Frame: At Week 24 and Week 48]

Change in the score of MS symptom severity scale (SymptoMScreen) [Time Frame: At Week 24 and Week 48]

Change in the score of Multiple Sclerosis International Quality Of Life Questionnaire (MusiQOL) [Time Frame: At Week 24 and Week 48]

Percentage of participants with no T1 gadolinium-enhancing lesion and no new and/or enlarging T2 lesion as detected by brain MRI [Time Frame: At Week 48]

Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM-14) [Time Frame: At Week 24 and Week 48]

Change in the score of Work Productivity and Activity Impairment scale (WPAI:SHP) [Time Frame: At Week 24 and Week 48]

Percentage of participants with stable, improved, or worsened expanded disability status scale (EDSS) [Time Frame: From Enrollment to Week 48]

Annualized relapse rate [Time Frame: At Week 48]

Change in the score of Modified Fatigue Impact Scale (MFIS) [Time Frame: At Week 24 and Week 48]

Percentage of participants with no new and/or enlarging T2 lesion as detected by brain MRI [Time Frame: At Week 48]

Percentage of participants with confirmed disability progression at Week 24 (CDP24) [Time Frame: At Week 48]

Mean Change in EDSS [Time Frame: From Baseline to Week 48]

Percentage of Participants with Adverse Events (AE) [Time Frame: From Baseline to Week 48]

Percentage of participants with no T1 gadolinium-enhancing lesion as detected by brain MRI [Time Frame: At Week 48]

Percentage of relapse-free RMS participants [Time Frame: From Enrollment to Week 24 and Week 48]

Secondary ID(s)

2018-000780-91

ML40359

Source(s) of Monetary Support

Please refer to primary and secondary sponsors