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

Completed

Conditions studied: Relapsing Remitting Multiple Sclerosis

In brief

The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ) by evaluating relapse rate, progression on MRI and disability progression.

Key facts

Study ID

NCT03157830

Run by

Providence Health & Services

People needed

43

Starts

2017-06-01

Expected to finish

2022-06-06

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female with relapsing form of MS, age 18 to 65, inclusive, at the time of informed consent.
• In the opinion of the investigator, able to understand the purpose and risk of the study and provide signed informed consent document.
• Must have received a stable dose of NTZ for 12 or more consecutive months, 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.

You may not qualify if…

• History of primary or secondary progressive multiple sclerosis.
• Evidence of active hepatitis B infection at screening.
• Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
• Patients with untreated hepatitis C or tuberculosis. Patients who have history of progressive multifocal leukoencephalopathy (PML) or known to be HIV positive, per standard care.
• Any persistent or severe infection.
• 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.

Where it is running

• RWJBarnabas Health — Livingston, New Jersey, United States
• Providence MS Center — Portland, Oregon, United States
• Kadlec Neuroscience Center — Richland, Washington, United States
• Multiple Sclerosis Center, Swedish Neuroscience Institute — Seattle, Washington, United States
• Providence Multiple Sclerosis Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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