Safety of Switching From Rituximab to Ocrelizumab in MS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ocrelizumab; Rituximab
Intervention description: A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells; A chimeric monoclonal antibody against CD20.
Intervention MeSH terms: Rituximab; Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective between and within group observational study to determine differences
      in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS)
      patients who have been administered at least two infusions of rituximab, six months apart and
      are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on
      rituximab as a comparison cohort from the clinic population treated as part of clinical care.
    

Eligibility criteria:

        Inclusion Criteria:

        Switching group:

          -  Current active patient of RMMSC

          -  18-65 years

          -  Diagnosis of relapsing forms of MS

          -  Completed ≥ two doses of rituximab with the last dose having been administered:

               1. Within 12 months of screening and

               2. At least 6 months prior to the first planned infusion of study drug

          -  Are receiving their current infusions of rituximab at the University of Colorado
             Outpatient Infusion Center

          -  Have discussed the possibility of switching to ocrelizumab with their MS provider

          -  Screened for Hepatitis B and C and TB within 2 years of first dose of ocrelizumab

          -  A negative serum pregnancy test must be available for premenopausal women and for
             women <12 months after the onset of menopause, unless they have undergone surgical
             sterilization.

          -  Women of childbearing potential must agree to use a "highly effective", hormonal form
             of contraception or two "effective" forms of non-hormonal contraception. Contraception
             must continue for the duration of study treatment and for at least three months after
             the last dose of study treatment

          -  Are able to complete patient reported outcomes developed as English written scales.

          -  Must be able and willing to give meaningful, written informed consent prior to
             participation in the trial, in accordance with local regulatory requirements

        Comparator group:

          -  Current active patient of RMMSC

          -  18-65 years

          -  Diagnosis of relapsing forms of MS

          -  Completed ≥ two doses of rituximab with the last dose having been administered within
             12 months of screening as standard of care

          -  Are receiving their current infusions of rituximab as standard of care at the
             University of Colorado Outpatient Infusion Center and will continue to do so

          -  Are willing to be followed for up to two additional rituximab infusions during the
             study period as standard of care

          -  Must be able and willing to give meaningful, written informed consent prior to
             participation in the trial, in accordance with local regulatory requirements

        Exclusion Criteria:

        Both groups:

          -  Pregnant or lactating women

          -  Hypersensitivity to trial medications

          -  Hepatic Dysfunction (liver enzymes are 5 times greater than normal)

          -  History of Congestive Heart Failure

          -  Any history of a positive blood assay for Hepatitis B or C

          -  Any history of TB or a positive Quantiferon Gold Assay

          -  Concurrent use of immunosuppressant medications

          -  Any history of immunodeficiency or other medical condition increasing risk of anti-CD
             20 therapy.

          -  No serious infection at the time of a scheduled study infusion.

          -  Any medical, psychiatric or other condition that could result in the patient not being
             able to give fully informed consent, or to comply with the protocol requirements as
             determined by the investigator