Relapsing Remitting Multiple SclerosisOCTAVENCT03157830
Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
An observational study of Relapsing Remitting Multiple Sclerosis, run by Providence Health & Services at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 43 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2017to 6 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
RWJBarnabas Health
Livingston, New Jersey, 07039
Providence MS Center
Portland, Oregon, 97225
Kadlec Neuroscience Center
Richland, Washington, 99352
Multiple Sclerosis Center, Swedish Neuroscience Institute
Seattle, Washington, 98122
Providence Multiple Sclerosis Center
Spokane, Washington, 99208
About this study
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.
Read the detailed 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 a stable dose of NTZ for 12 or more consecutive months, 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, ocrelizumab, OCREVUS, Natalizumab, Tysabri
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival at Month 12
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
Measured: 12 Months
Secondary outcomes (7)
Relapse Rate at Months 3, 6, and 9
Proportion of relapse-free patients at months 3, 6, and 9
Measured: 3, 6, and 9 months
MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Proportion of patients free from MRI evidence of MS disease activity at months 3, 6, and 12
Measured: 3, 6, and 12 Months
New or Enlarging T2 Lesions at 3, 6, and 12 Months
Proportion of patients with New or Enlarging T2 lesions at 3, 6, and 12 months. For patients with New or Enlarging T2 lesions, number of New and Enlarging T2 lesions.
Measured: 3, 6, and 12 months
New Gd+ Lesions Detected at Months 3, 6, and 12
Proportion of patients with New Gd+ lesions detected at months 3, 6, and 12. For patients with New Gd+ lesions, number of New Gd+ lesions
Measured: 3, 6, and 12 months
Change in the EDSS Score From Baseline to Month 12
Average change in EDSS score. The Expanded Disability Status Scale (EDSS) is an assessment used by neurologist to assess changes in the level of disability over time in patients with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scores are also based on measures of impairment in the 8 functional systems. Higher scores indicate greater impact of MS on QoL.
Measured: 12 months
Change in MSIS-29 From Baseline to Months 6 and 12
Average change in MSIS-29: Multiple Sclerosis Impact Scale (MSIS) is a patient reported outcome (PRO) measure, consisting of two subscales- physical impact of MS (20 items) and psychological impact (9 items). It asks subject to rate the impact MS has their daily life in the past 2 weeks (1=low impact to 4=large impact). Scores from individual items are summed to a total score. Physical impact score ranges from 20-80 and psychological impact scores ranges from 9-36.
Higher scores indicate greater impact of MS on QoL.
Measured: 6 and 12 months
Proportion of Patients That Discontinued OCR
Proportion of patients that stop treatment with OCR for any reason
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jun 2017
- Primary completion28 Jan 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Kyle Smoot, MD, Principal investigator, Providence Brain & Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157830
- Sponsor's protocol ID
- ML39655
- Acronym
- OCTAVE
- Status last verified
- Sep 2024
- First submitted
- 15 May 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37317841
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
- ClinicalTrials.gov ID
- NCT03157830
- Acronym / sponsor ID
- OCTAVE / ML39655
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, ocrelizumab, OCREVUS, Natalizumab, Tysabri
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 a stable dose of NTZ for 12 or more consecutive months, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse Free Survival at Month 12
Time frame: 12 Months
The proportion of relapse-free patients at month 12 after switching from natalizumab to ocrelizumab.
7 secondary outcomes
Relapse Rate at Months 3, 6, and 9
Time frame: 3, 6, and 9 months
MRI Evidence of MS Disease Activity at Months 3, 6, and 12
Time frame: 3, 6, and 12 Months
New or Enlarging T2 Lesions at 3, 6, and 12 Months
Time frame: 3, 6, and 12 months
New Gd+ Lesions Detected at Months 3, 6, and 12
Time frame: 3, 6, and 12 months
Change in the EDSS Score From Baseline to Month 12
Time frame: 12 months
Change in MSIS-29 From Baseline to Months 6 and 12
Time frame: 6 and 12 months
Proportion of Patients That Discontinued OCR
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37317841Smoot 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.
- Providence Brain \& Spine InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Relapsing Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Smoot, MD principal investigator
Providence Brain & Spine Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Providence Health & Services at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Free Survival at Month 12 (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.