A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

  • Interventional
  • Recruiting
  • NCT03523858
Eligibility Details Visit Clinicaltrials.gov

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Gender
All

Age Group
18 Years to 65 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)

         - EDSS (Expanded Disability Status Scale) </ =6.5 at screening

         - Have a length of disease duration since Progressive Multiple Sclerosis (PMS) disease symptom onsent </= 10 years if baseline Expanded Disability Status Scale (EDSS) </=5.0 and </=15 years if baseline EDSS >5.0

         - 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

         - 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

         - Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers

         - 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:

         - Relapsing-remitting multiple sclerosis (RRMS) at screening

         - Inability to complete an MRI

         - Gadolinium (Gd) intolerance

         - Known presence of other neurological disorders

        Exclusions Related to General Health:

         - Positive screening tests for hepatitis B

         - Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening

         - Lactation

         - Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study

         - History or currently active primary or secondary immunodeficiency

         - Lack of peripheral venous access

         - Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.

         - Active infections must be treated and resolved before possible inclusion in the study.

         - Participants in a severely immunocompromised state until the condition resolves

         - Participants with known active malignancies or being actively monitored for recurrence of malignancy

         - Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)

        Exclusions Related to Medications:

         - Hypersensitivity to ocrelizumab or to any of its excipients

         - Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, tabalumab, belimumab, ofatumumab, or obinutizumab)

         - Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation

         - Previous treatment with natalizumab where PML has not been excluded according to specific algorithm

         - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label

         - Systemic corticosteroid therapy within 4 weeks prior to screening

         - All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted

         - Previous treatment with daclizumab or figolimod in the last 8 weeks

         - Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening

         - Previous treatment with natalizumab in the last 12 weeks

         - Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks

         - Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS

         - Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks

         - Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

        Exclusions for Participants in the Optical Coherence Tomography (OCT) Assessments:

        - Participants with clinically relevant ocular pathologies, potentially interfering with clinical and instrumental evaluations

        Exclusions for Participants Participating in the Measurement of Motor Evoked Potentials:

         - History of seizures

         - Prior craniotomy or skull fracture

         - Movable metallic implant in the head

         - Implanted stimulators (e.g. cochlear implant or cardiac pacemaker, deep brain stimulator)

         - Known history of high intracranial pressure

At a Glance

National Government IDNCT03523858

IRB#IRB18-1280

Lead SponsorHoffmann-La Roche

Lead PhysicianAnthony T. Reder

Collaborator(s)N/A

EligibilityAll
18 Years to 65 Years
Recruiting