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

Relapsing Remitting Multiple Sclerosis Clinical Trial

— OCTAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157830
• Other study ID #: 2017000156
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a multicenter, prospective, open-label, Phase IV clinical trial. Patients with relapsing forms of Multiple Sclerosis (MS), ages 18 to 65, who have received 12 or more continuous infusions of NTZ, and have been free of relapses, disability worsening or Magnetic Resonance Imaging (MRI) progression 6 months prior to the transition screening visit will be eligible for the study. After informed consent to participate has been obtained, the patient will have physical exam (PE), non-blinded Expanded Disability Status Scale (EDSS), MRI, Multiple Sclerosis Impact Scale (MSIS-29) and labs done for the screening visit to determine eligibility. Brain MRI with and without contrast will be performed with the standard MS protocol. MRIs will be performed with 3mm slice thickness with no gaps between slices. Patients will receive their first dose of OCR 4 to 6 weeks after the last dose of NTZ. Other baseline measures, including physical exam, EDSS, MSIS-29, and labs will be performed within 4 weeks of screening. Physical exam, non-blinded EDSS, and labs will be performed at month 3, month 6, month 9, and month 12. MSIS-29 will be performed at months 6 and 12. In addition, MRIs will be performed at months 3, 6, and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Providence Health & Services	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rate at 12 months	the proportion of relapse-free patients at month 12 after switching from NTZ to OCR	12 Months
Secondary	Relapse Rate at Months 3, 6, and 9	Proportion of relapse-free patients at months 3, 6, and 9	3, 6, and 9 months
Secondary	Mean time to first relapse on OCR	Average time to first relapse	12 months
Secondary	Change in the EDSS score from baseline to month 12	Average change in EDSS score	12 months
Secondary	Change in MSIS-29 from baseline to months 6 and 12	Average change in MSIS-29 score	6 and 12 months
Secondary	Proportion of patients that discontinued OCR	Proportion of patients that stop treatment with OCR for any reason	12 months

External Links

•   Providence Brain & Spine Institute