A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

Phase 1

• Conditions: Relapsing remitting multiple sclerosis (RRMS); MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002937-31-SI
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-13
• Study Completion: 2023-04-27
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1225

Inclusion Criteria

- Able to comply with the study protocol, in the investigator's judgment
- Age 18 - 55 years, inclusive
- Have a definite diagnosis of RRMS, as per the revised McDonald 2010
criteria
- Have a length of disease duration, from first documented clinical
attack consistent with multiple sclerosis (MS) disease of <= 3 years
- Within the last 12 months: one or more clinically reported relapse(s)
or one or more signs of MRI activity
- Expanded Disability Status Scale (EDSS) of 0.0 to 3.5 inclusive, at
screening
- For women of childbearing potential: agreement to use an acceptable
birth control method during the treatment period and for at least 6
months or longer after the last dose of ocrelizumab, as applicable in the
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 1225
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Secondary progressive multiple sclerosis or history of primary
progressive or progressive relapsing MS
- Inability to complete a Magnetic resonance imaging (MRI)
- Known presence of other neurological disorders, including but not
limited to, the following:
• History of ischemic cerebrovascular disorders or ischemia of the spinal
cord
• History or known presence of central nervous system (CNS) or spinal
cord tumor
• History or known presence of potential metabolic causes of
myelopathy
• History or known presence of infectious causes of myelopathy
• History of genetically inherited progressive CNS degenerative disorder
• Neuromyelitis optica
• History or known presence of systemic autoimmune disorders
potentially causing progressive neurologic disease
• History of severe, clinically significant brain or spinal cord trauma
Exclusions Related to General Health
- Pregnancy or lactation
- Patients intending to become pregnant during the study or within 6
months after the last dose of the study drug
- Any concomitant disease that may require chronic treatment with
systemic corticosteroids or immunosuppressants during the course of
the study
- History or currently active primary or secondary immunodeficiency
- Lack of peripheral venous access
- History of severe allergic or anaphylactic reactions to humanized or
murine monoclonal antibodies
- Significant or uncontrolled somatic disease or any other significant
disease that may preclude patient from participating in the study
- Congestive heart failure [NYHA] III or IV functional severity).
- Known active bacterial, viral, fungal, mycobacterial infection or other
infection, or any major episode of infection requiring hospitalization or
treatment with intravenous antibiotics within 4 weeks prior to screening
or oral antibiotics 2 weeks prior to screening
- History of major opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy, including solid tumors and hematological
malignancies
- History of alcohol or drug abuse within 24 weeks prior to baseline
- History or laboratory evidence of coagulation disorders
Exclusions Related to Medications
- Received any prior approved Disease modifying treatment (DMT) with
a label for MS, for example, interferons, glatiramer acetate, natalizumab,
alemtuzumab, daclizumab, fingolimod, teiflunomide and
dimethylfumarate
- Received a live vaccine or attenuated live vaccine within 6 weeks
prior to the baseline visit
- Treatment with any investigational agent within 24 weeks of
screening or five half-lives of the investigational drug or treatment with
any experimental procedures for MS
- Contraindications to or intolerance of oral or intravenous (IV)
corticosteroids, including methylprednisolone administered IV, according
to the country label.
- Previous treatment with B-cell targeted therapies
- Systemic corticosteroid therapy within 4 weeks prior to screening.
- Any previous treatment with immunosuppressants/
immunomodulators/ antineoplastic therapies
- Treatment with IV Immunoglobulin within 12 weeks prior to baseline
- Treatment with investigational DMT
- History of recurrent aspiration pneumonia requiring antibiotic
therapy
- Treatment with fampridine/dalfamipridine unless on stable dose for
= 30 days prior to screening. Wherever possible, pa

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified