Relapsing Multiple SclerosisNCT06526000
Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
An observational study of Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Novartis at 1 site in United States.
Trial summary
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2022to 28 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Patients aged 18 years or older at index.
- Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
- Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
- Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.
Who cannot join
- Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
- Participated in an anti-CD20 drug clinical trial during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Retrospective EMR Study to Assess Changes in Immunoglobulins in Patients With Relapsing Forms of Multiple Sclerosis Treated With Anti-CD20 Monoclonal Antibodies
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.
The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.
- Conditions
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
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 |
|---|---|---|
| Relapsing Multiple Sclerosis Cohort | Patients with relapsing forms of multiple sclerosis who had newly initiated anti-CD20 treatment after March 2017. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab
Measured: Up to 5 years
Secondary outcomes (3)
Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values
Low immunoglobulin values were defined as greater than or equal to 1 immunoglobulin G (IgG) lab value of less than 500 milligrams per deciliter (mg/dL) or greater than or equal to 1 immunoglobulin M (IgM) lab value of less than 25 mg/dL.
Measured: Up to 5 years
Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab
Measured: Up to 5 years
Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab
Risk factors included: age and disease duration.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start11 Oct 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing 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
- Retrospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526000
- Sponsor's protocol ID
- COMB157GUS26
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective EMR Study to Assess Changes in Immunoglobulins in Patients With Relapsing Forms of Multiple Sclerosis Treated With Anti-CD20 Monoclonal Antibodies
- ClinicalTrials.gov ID
- NCT06526000
- Acronym / sponsor ID
- COMB157GUS26
- Conditions
- Relapsing Multiple Sclerosis, Clinically Isolated Syndrome, Relapsing-remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 29 Jul 2024 (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.
This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.
The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsing Multiple Sclerosis Cohort | – | –Patients with relapsing forms of multiple sclerosis who had newly initiated anti-CD20 treatment after March 2017. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older at index.
- Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
- Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
- Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.
Key exclusion criteria (2 listed)
- Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
- Participated in an anti-CD20 drug clinical trial during the study period.
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
Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab
Time frame: Up to 5 years
3 secondary outcomes
Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values
Time frame: Up to 5 years
Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab
Time frame: Up to 5 years
Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab
Time frame: Up to 5 years
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 29 Jul 2024.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Multiple Sclerosis and Clinically Isolated Syndrome, run by Novartis at 1 site 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 4 inclusion and 2 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab (time frame: Up to 5 years). 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 29 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.