Multiple SclerosisNCT04123353
Scan-Rescan Sub-Study of MS PATHS
An observational study of Multiple Sclerosis, run by Biogen at 3 sites in United States.
Trial summary
The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants… Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Feb 2017to 9 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Potential participants will be participants with MS enrolled in Study 888MS001 who have varying levels of disease severity and symptom duration.
Who may be able to join
- Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
- Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
- First MS symptom within the past 1 to 30 years.
Who cannot join
- Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
- Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.
- Note: Other protocol specified inclusion and exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Baltimore, Maryland, 21205
Research Site
Cleveland, Ohio, 44195
Research Site
New York, New York, 10016
About this study
Official title: Reproducibility of Brain Volume and Lesion Measurements in Multiple Sclerosis: a Scan-Rescan Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Reproducibility of Brain Volume
Measured: Baseline up to Day 7
Overall Reproducibility of Lesions
Measured: Baseline up to Day 7
Intrascanner Reproducibility of Brain Volume
Measured: Baseline up to Day 7
Intrascanner Reproducibility of Lesions
Measured: Baseline up to Day 7
Interscanner Reproducibility of Brain Volume
Measured: Baseline up to Day 7
Interscanner Reproducibility of Lesions
Measured: Baseline up to Day 7
Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions
Measured: Baseline up to Day 7
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
Measured: Baseline up to Day 7
Sensitivity and Specificity for Lesion Detection
Measured: Baseline up to Day 7
Secondary outcomes (1)
Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners
Measured: Baseline up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start11 Feb 2017
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123353
- Sponsor's protocol ID
- 888MS004
- Status last verified
- Oct 2019
- First submitted
- 24 Sep 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Brain Volume and Lesion Measurements in Multiple Sclerosis: a Scan-Rescan Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
- ClinicalTrials.gov ID
- NCT04123353
- Acronym / sponsor ID
- 888MS004
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
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 sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Potential participants will be participants with MS enrolled in Study 888MS001 who have varying levels of disease severity and symptom duration.
Key inclusion criteria (3 listed)
- Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
- Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
- First MS symptom within the past 1 to 30 years.
Key exclusion criteria (3 listed)
- Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
- Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.
- Note: Other protocol specified inclusion and exclusion criteria may apply.
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
Overall Reproducibility of Brain Volume
Time frame: Baseline up to Day 7
Overall Reproducibility of Lesions
Time frame: Baseline up to Day 7
Intrascanner Reproducibility of Brain Volume
Time frame: Baseline up to Day 7
Intrascanner Reproducibility of Lesions
Time frame: Baseline up to Day 7
Interscanner Reproducibility of Brain Volume
Time frame: Baseline up to Day 7
Interscanner Reproducibility of Lesions
Time frame: Baseline up to Day 7
Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions
Time frame: Baseline up to Day 7
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
Time frame: Baseline up to Day 7
Sensitivity and Specificity for Lesion Detection
Time frame: Baseline up to Day 7
1 secondary outcome
Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners
Time frame: Baseline up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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.
Medical Director study director
Biogen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 3 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 3 inclusion and 3 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Reproducibility of Brain Volume (time frame: Baseline up to Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2019.