RKHO_PROVIDENCE_2017000156_OCTAVE

Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab.

Inclusion Criteria:

Able to understand the purpose and risk of the study and provide signed informed consent document.
Must have received 12 or more consecutive monthly infusions of NTZ, and have had no evidence of on-NTZ disease activity (clinically or on MRI) for the 6 months prior to the screening visit.
Naïve to OCR.
No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
EDSS of ≤ 6.0 at screening.
Female patients of childbearing potential must practice effective contraception and continue contraception during the study.
Exclusion Criteria:

History of primary or secondary progressive multiple sclerosis.
Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
Patients with a known history of hepatitis B, hepatitis C, tuberculosis, PML, or who are HIV positive.
Any persistent or severe infection.
Any malignancy within 5 years, except for basal or squamous cell skin lesions, which have been surgically excised, with no evidence of metastasis.
Pregnancy or lactation.
Significant or uncontrolled somatic disease or severe depression in the last year.
Inability to complete an MRI.
Previous treatment with B-cell targeted therapies.
Current use of immunosuppressive medication.
Patients who have had evidence of disease activity within the 6 months prior to screening. This includes MS relapse, or new or enlarging T2 lesions or Gd+ enhancing lesions, or disability progression.
Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
Phase IV
NCT03157830
Neurosciences
Multiple Sclerosis
Hui-Juan Zhang, M.D.
Providence Health & Services
Vikki Otero
  • Kadlec Neuroscience Center
  • Kadlec Research