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

NCT03157830 | Completed Results DMC

• 1 other identifier: ML39655
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; ocrelizumab; OCREVUS; Natalizumab; Tysabri

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival at Month 12

  The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.

  12 Months

Secondary Outcomes (7)

• Relapse Rate at Months 3, 6, and 9

  3, 6, and 9 months

• MRI Evidence of MS Disease Activity at Months 3, 6, and 12

  3, 6, and 12 Months

• New or Enlarging T2 Lesions at 3, 6, and 12 Months

  3, 6, and 12 months

• New Gd+ Lesions Detected at Months 3, 6, and 12

  3, 6, and 12 months

• Change in the EDSS Score From Baseline to Month 12

  12 months

Study Arms (1)

Ocrelizumab, OCREVUS

Patients eligible for this study will be receiving OCREVUS as part of their routine care for MS treatment, and undergo the standard monitoring tests and procedures for MS patients receiving treatment. In addition, they will complete the EDSS scale on 6 occasions over a 12-month period, and the MSIS-29 on three occasions during the 12 month period for research.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with relapsing forms of MS, ages 18 to 65, must have received a stable dose of NTZ for 12 or more consecutive months, and have been free of relapses, disability worsening or MRI progression 6 months prior to switching from NTZ to OCR therapy are eligible to participate.

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.

Sponsors & Collaborators

• Providence Health & Services: lead
• Genentech, Inc.: collaborator

Study Sites (5)

RWJBarnabas Health

Livingston, New Jersey, 07039, United States

Location

Providence MS Center

Portland, Oregon, 97225, United States

Location

Kadlec Neuroscience Center

Richland, Washington, 99352, United States

Location

Multiple Sclerosis Center, Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Providence Multiple Sclerosis Center

Spokane, Washington, 99208, United States

Location

Related Publications (1)

• Smoot K, Marginean H, Gervasi-Follmar T, Chen C, Repovic P, Cohan S. Evaluating the efficacy and safety of transitioning patients with multiple sclerosis from natalizumab to ocrelizumab (OCTAVE). Mult Scler. 2023 Jul;29(8):956-966. doi: 10.1177/13524585231175284. Epub 2023 Jun 15.

  PMID: 37317841 DERIVED

Related Links

• Providence Brain \& Spine Institute

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of PBSI /WC Clinical Research Program
• Organization: Providence Health & Services

Chiayi.Chen@providence.org

(503) 216-1012

Study Officials

• Kyle Smoot, MD

  Providence Brain & Spine Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: June 1, 2017
• Primary Completion: January 28, 2022
• Study Completion: June 6, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)