STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE)

Phase 1

• Conditions: ACTIVE RELAPSING MULTIPLE SCLEROSIS (Active RMS); MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000780-91-FR
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-30
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

o Signed informed consent form
o Age =18 years at screening
o Patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features:
- At least one clinical relapse over a 6-month period prior to screening
- AND/OR at least one T1 gadolinium-enhancing lesion or new and/or enlarging T2 lesion as detected by brain MRI performed over a 3 months period prior to screening with no change of DMT compared to a previous MRI performed within 24 months before screening
o 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.
o Patients should be beneficiary of healthcare coverage under the social security system

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 570
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

o Diagnosis of primary progressive MS
o Inability to complete an MRI
o Gadolinium intolerance
o Known presence of other neurological disorders,
o Patients not able to comply with the study protocol, in the investigator’s judgment
o Vulnerable patients
o Pregnancy or lactation
o Current active infection
o Severely immunocompromised state
o Known active malignancies
o Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
o Lack of peripheral venous access
o Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study
o History or known presence of progressive multifocal leukoencephalopathy
o Hypersensitivity to ocrelizumab or to any of the excipients
o Receipt of any vaccine within 6 weeks prior to the baseline visit.
o Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS within 24 weeks prior to screening
o Previous treatment with CD20 B-cell targeted therapies (i.e., rituximab, ocrelizumab, or ofatumumab) in the last 12 months
o Any previous treatment with alemtuzumab Campath®/Mabcampath®/Lemtrada®), total body irradiation, or bone marrow transplantation
o Previous treatment with natalizumab or fingolimod in the last 8 weeks
o Previous treatment with daclizumab in the last 12 weeks
o Previous treatment with natalizumab where PML has not been excluded according to specific algorithm in Appendix 5
o Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
o Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 2 years
o Treatment with dimethyl fumarate within five half-lives of dimethyl fumarate prior to screening
o Treatment with biotin within five half-lives of biotin prior to screening
o Patients previously treated with teriflunomide, unless an accelerated elimination procedure is implemented before screening visit
o Contraindications to or intolerance of antihistamine drugs, oral or IV corticosteroids, including methylprednisolone administered IV, according to the country label, including psychosis not yet controlled by a treatment and hypersensitivity to any of the constituents
o Treatment with IV Ig within 12 weeks prior to baseline
o Systemic corticosteroid therapy within 4 weeks prior to screening
o Treatment with fampridine/dalfampridine (Fampyra®)/Ampyra®) or other symptomatic MS treatment unless on stable dose for =30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the treatment period
o Positive serum ? human chorionic gonadotropin (hCG) measured at screening
o Positive hepatitis B surface antigen [HBsAg] at screening.

Study & Design

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