Multiple SclerosisNCT07844070
A Study of Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study aims to assess the real-world patterns of disease modifying therapy (DMT) use before, during, and after pregnancy in women with multiple sclerosis (MS). The study will use a pooled closed claims database containing closed payer medical and pharmacy claims data for patients in the United States (US). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 2,607 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a confirmed diagnosis of MS who had a live birth any time from August 20, 2020 to September 30, 2024 (identification period) or 6 months prior to end of study period.
Who may be able to join
- ≥1 claim with a diagnosis or procedure code for live birth during the patient identification period (index date).
- o Note: For patients with more than one pregnancy in the patient identification period, all eligible pregnancies will be included.
- Female sex recorded on enrollment record overlapping with index date.
- Aged between 18 and 49 years old at index date.
- ≥2 claims with an MS diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code G35) ≥30 days apart in the pre-conception or pregnancy periods.
- Continuous healthcare plan enrollment from ≥6 months prior to the conception date to ≥6 months following the index date.
Who cannot join
- Pregnancies involving multiples, subject to data availability.
- Malignancy in pre-conception, pregnancy, or post-delivery periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
This study aims to assess the real-world patterns of disease modifying therapy (DMT) use before, during, and after pregnancy in women with multiple sclerosis (MS). The study will use a pooled closed claims database containing closed payer medical and pharmacy claims data for patients in the United States (US).
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Pregnancy, Disease-Modifying Therapy, Peripartum, Postpartum Period, Treatment Patterns, Womens Health, Real-World Evidence, Healthcare Claims Data, Retrospective Cohort Study
- Medical subject headings
- 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 |
|---|---|---|
| MS Group | Women with MS who experienced at least one live birth between August 20, 2020 and September 30, 2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With ≥1 DMT Claim During the Pre-Conception Period
Measured: 6 months prior to the estimated conception date
Proportion of Patients With ≥1 DMT Claim During Pregnancy
Measured: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients With ≥1 DMT Claim During the Post-Delivery Period
Measured: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Secondary outcomes (11)
Proportion of Patients by Demographic and Clinical Characteristics
Demographics and clinical characteristics include:
- Age group
- Race
- Geographical region
- Type of healthcare insurance coverage
- Payer type
- Year of index date
- Mode of delivery
- Use of fertility treatments
- Deyo-Charlson Comorbidity Index (DCCI) category (0, 1-2, ≥3)
- Psychological Diagnosis Group (PDG)
- Comorbidities
- MS-related symptoms and secondary conditions
- MS disability (no disability symptoms, mild, moderate, severe)
Measured: 6 months prior to the estimated conception date
DCCI Score
DCCI is an adaptation of the Charlson Comorbidity Index that uses diagnosis codes from administrative or claims data to quantify a patient's burden of comorbid conditions. It assigns weighted scores to a set of medical conditions based on their impact on mortality risk. DCCI scores start at 0, with higher scores indicating a greater number of and/or severe comorbid conditions.
Measured: 6 months prior to the estimated conception date
Number of PDG Mental Health Disorders
PDG captures a list of mental health disorders a patient may have. The following are the list of PDGs:
- Adult personality disorders
- Anxiety disorders
- Behavioral syndromes
- Childhood and adolescent psychiatric syndromes
- Intellectual disabilities
- Psychiatric disorders with known physiological causes
- Mood disorders
- Pervasive disorders
- Schizophrenia
- Substance use
Measured: 6 months prior to the estimated conception date
Age
Measured: 6 months prior to the estimated conception date
Proportion of Patients by DMT Use During the Pre-Conception Period
Proportion of patients by type of DMT used during pre-conception reported by DMT class and generic name.
Measured: 6 months prior to the estimated conception date
Proportion of Patients by DMT Use During Pregnancy
Proportion of patients by type of DMT used during pregnancy reported by DMT class and generic name.
Measured: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients by DMT Use During the Post-Delivery Period
Proportion of patients by type of DMT used post-delivery reported by DMT class and generic name.
Measured: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Proportion of Patients by Sequences of DMTs Used During the Pre-Conception Period
Measured: 6 months prior to the estimated conception date
Proportion of Patients by Sequences of DMTs Used During Pregnancy
Measured: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients by Sequences of DMTs Used During the Post-Delivery Period
Measured: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Time to First Observed DMT Claim in the Post-Delivery Period
Time to first observed DMT claim in the post-delivery period among (a) patients without a DMT claim in the pre-conception or pregnancy periods (i.e., time to DMT initiation) and (b) patients with a DMT claim in the pre-conception and/or pregnancy periods (i.e., time to DMT continuation).
Measured: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start6 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
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 Novartis PharmaceuticalsThe 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
- 2,607 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844070
- Sponsor's protocol ID
- COMB157GUS41
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Modifying Therapy Use in Women With Multiple Sclerosis Before, During, and After Pregnancy
- ClinicalTrials.gov ID
- NCT07844070
- Acronym / sponsor ID
- COMB157GUS41
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Pregnancy, Disease-Modifying Therapy, Peripartum, Postpartum Period, Treatment Patterns, Womens Health, Real-World Evidence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,607 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Sep 2026 (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 study aims to assess the real-world patterns of disease modifying therapy (DMT) use before, during, and after pregnancy in women with multiple sclerosis (MS). The study will use a pooled closed claims database containing closed payer medical and pharmacy claims data for patients in the United States (US).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS Group | – | –Women with MS who experienced at least one live birth between August 20, 2020 and September 30, 2024. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a confirmed diagnosis of MS who had a live birth any time from August 20, 2020 to September 30, 2024 (identification period) or 6 months prior to end of study period.
Key inclusion criteria (6 listed)
- ≥1 claim with a diagnosis or procedure code for live birth during the patient identification period (index date).
- o Note: For patients with more than one pregnancy in the patient identification period, all eligible pregnancies will be included.
- Female sex recorded on enrollment record overlapping with index date.
- Aged between 18 and 49 years old at index date.
- ≥2 claims with an MS diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code G35) ≥30 days apart in the pre-conception or pregnancy periods.
Key exclusion criteria (2 listed)
- Pregnancies involving multiples, subject to data availability.
- Malignancy in pre-conception, pregnancy, or post-delivery periods.
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
Proportion of Patients With ≥1 DMT Claim During the Pre-Conception Period
Time frame: 6 months prior to the estimated conception date
Proportion of Patients With ≥1 DMT Claim During Pregnancy
Time frame: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients With ≥1 DMT Claim During the Post-Delivery Period
Time frame: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
11 secondary outcomes
Proportion of Patients by Demographic and Clinical Characteristics
Time frame: 6 months prior to the estimated conception date
DCCI Score
Time frame: 6 months prior to the estimated conception date
Number of PDG Mental Health Disorders
Time frame: 6 months prior to the estimated conception date
Age
Time frame: 6 months prior to the estimated conception date
Proportion of Patients by DMT Use During the Pre-Conception Period
Time frame: 6 months prior to the estimated conception date
Proportion of Patients by DMT Use During Pregnancy
Time frame: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients by DMT Use During the Post-Delivery Period
Time frame: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Proportion of Patients by Sequences of DMTs Used During the Pre-Conception Period
Time frame: 6 months prior to the estimated conception date
Proportion of Patients by Sequences of DMTs Used During Pregnancy
Time frame: Day 0 to 90 (Trimester 1), Day 91 to 181 (Trimester 2), Day 182 up to and including the day before the delivery date (Trimester 3), and Day 0 up to approximately Day 280 (pregnancy period)
Proportion of Patients by Sequences of DMTs Used During the Post-Delivery Period
Time frame: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Time to First Observed DMT Claim in the Post-Delivery Period
Time frame: Post-delivery 0 to 1.5 months, 1.5 to 3 months, 4 to 6 months, >6 months, up to approximately 4.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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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 Multiple Sclerosis, run by Novartis Pharmaceuticals 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 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of Patients With ≥1 DMT Claim During the Pre-Conception Period (time frame: 6 months prior to the estimated conception date). The study lists 3 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 28 Sep 2026.