Relapsing-remitting Multiple SclerosisCOMBAT-MSNCT03193866

COMparison Between All immunoTherapies for Multiple Sclerosis.

An observational study of Relapsing-remitting Multiple Sclerosis, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsing-remitting Multiple Sclerosis
What is being tested?: Rituximab
How many people: 3,526 participants
Where: 1 siteSweden
Study dates: 2 Jun 2017to 31 Mar 2022
How long will I take part?: 3 Years
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients initiated at their first or second disease-modifying drug between January 1 2011 and June 30 2018 will be included in the trial. Up to present date, study-related data will be retrospectively controlled via individual study of patient records. Patients will be identified through the Swedish MS registry. Inclusion into the COMBAT-MS core study will be subject to written informed consent. Given the non-intervention design of the study and very limited study-specific procedures outside of clinical practise, we expect participation rates to be very high. Based on preliminary calculations from the MS registry the projected number of participants will be 3700 patients, out of which at least 1000 are treated with rituximab first or second-line.

Who may be able to join

The study population consists of all patients with Clinically Isolated Syndrome (CIS) or RRMS who;
Initiate a first MS DMT (treatment naïve), or Initiate a second ever DMT, of a different drug class than the first, regardless of time between drugs or reason for discontinuation("switchers") from 1st Jan 2011 to 30st June 2018, and
Are followed at any of the University clinics of Sweden, and
Consent to participation in COMBAT-MS core, and
Are expected to be capable to follow study assessments.

Who cannot join

Patients with progressive forms of MS at start of therapy are not eligible

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Fredrik Piehl
Stockholm

Other trials in Sweden

About this study

Official title: COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis

Read the detailed description

This is a prospective non-intervention observational prospective cohort study assessing the long-term safety and efficacy of RTX treatment in MS compared with other common MS DMTs regarding both clinical and radiological parameters in a real-life population of patients with MS.

A number of parameters will be assessed annually. These include baseline demographics, previous drug history and reasons for discontinuation, disability status (expanded disability status scale), relapses, safety and adverse events (AE), contrast enhancing T1 and newly appearing T2 lesions on magnetic resonance imaging, as well as a panel of patient reported outcome measures: Symbol Digit Modalities Test (SDMT); MS impact scale-29 (MSIS-29) Fatigue Scale for Motor and Cognitive Functions (FSMC), EuroQol-5 Dimensions (EQ-5D), the MS check scale and Treatment Satisfaction Questionnaire 9 (TSQM-9).

Retrospective data entered in medical charts and the Swedish MS registry will be included together with prospective annual structured follow up from inclusion into the study for a minimum of three years (three to nine years).

In a substudy - Covid Enhancement study - analyses will be performed regarding the effect of COVID-19 on people with MS as compared to non-MS individuals and also if there is any indication that a particular DMD is associated with a risk to contract a more severe COVID-19. The analyses will primarily be performed in official health care databases.

Conditions: Relapsing-remitting Multiple Sclerosis
Being tested: Rituximab
Keywords: Immunomodulating treatment, Cohort study, Dimethyl fumarate, Fingolimod, Interferon-beta, Natalizumab, Rituximab, Glatiramer acetate
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RituximabDrug
Also called Natalizumab, Fingolimod, Alemtuzumab, Interferon-beta
Comparisons of efficacy and safety between rituximab and all other frequently used immunomodulating drugs against multiple sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
Proportion of patients with baseline EDSS <2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up.
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Measured: 3 years
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
- Proportion of patients with baseline EDSS ≥2.5 experiencing 12 months confirmed EDSS increase of 1 point among those over 3 years of follow up
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Measured: 3 years
Disease-related Impact on Daily Life, Physical
- Change in the MSIS-29 physical subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) physical subscale measures patient-reported physical impact of multiple sclerosis.
Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Measured: 3 years
Disease-related Impact on Daily Life, Psychological
- Change in the MSIS-29 psychological subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) psychological subscale measures patient-reported psychological impact of multiple sclerosis.
Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Measured: 3 years

Secondary outcomes (12)

Annualized Relapse Rate
- Comparison of mean number of relapses per year between the different treatments
Measured: 3 years
Remaining on Drug
- Proportion remaining on the index DMT after 3 years
Measured: 3 years
Increase in EDSS
- Comparison of yearly increase in mean EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Measured: 3 years
Proportion of Patients With at Least 1 Step Increase in EDSS
- Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments
Expanded Disability Status Scale (EDSS) scale range:
Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Measured: 3 years
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
- Comparison of yearly proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments.
Lower NEDA-2 scores indicate better outcomes. Higher NEDA-2 scores indicate worse outcomes.
Measured: 3 years
Proportion of Patients With NEDA-3
- Comparison of yearly proportion of patients with NEDA-3 (NEDA-2 plus no confirmed worsening of EDSS from baseline).
Lower NEDA-3 scores indicate better outcomes. Higher NEDA-3 scores indicate worse outcomes.
Measured: 3 years
Quality of Life Assessments
Comparison of health-related quality of life measured by the European Quality of Life Five Dimensions (EQ-5D). Higher values indicate better health, and lower values indicate poorer health. The maximum theoretical value is 1. While there is no fixed minimum, scores can fall below 0, indicating health states worse than death. In this study, scores ranged from -0.59 to 1, which represent clinically relevant ranges of values.
Measured: 3 years
Fatigue
Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC).
The fatigue scale for motor and cognitive functions (FSMC) scale range: Minimum score: 20. Maximum score: 100. Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Measured: 3 years
Treatment Satisfaction
Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ), items 1-9, restricted to patients remaining on index DMT at 3 years.
The Treatment Satisfaction Questionnaire (TSQ), items 1-9 scale range: Minimum score: 0. Maximum score: 100. Lower scores indicate worse outcomes. Higher scores indicate better outcomes.
Measured: 3 years
Rate of Serious Infections
- Rate of serious infections, defined as hospitalizations where the main diagnosis included an ICD-10 diagnosis code in the national patient register in the 3 years after initiating index DMT
Measured: 3 years
Rate of Major Adverse Cardiovascular Events (MACE)
- Rate of MACE, defined as acute coronary syndrome, stroke or death from any cardiovascular cause based on corresponding ICD-codes in the national patient and cause of death registries in the 3 years after initiating index DMT
Measured: 3 years
Rate of Invasive Cancer
- Rate of incident invasive cancer, defined as invasive cancers based on corresponding ICD-codes in the national cancer registry in the 3 years after initiating index DMT.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 201731 Mar 2022

First posted21 Jun 2017
Study start2 Jun 2017
Primary completion31 Mar 2022
Study completion31 Mar 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.
More trials run by Karolinska InstitutetThe 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: Other
Enrolment: 3,526 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193866
Sponsor's protocol ID: COMBAT-MS
Acronym: COMBAT-MS
Status last verified: Mar 2025
First submitted: 20 Apr 2017
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Englund S, Frisell T, Qu Y, Gandhi K, Hulten A, Kierkegaard M, Piehl F, Longinetti E. Trajectories of self-reported fatigue following initiation of multiple sclerosis disease-modifying therapy. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1012-1020. doi: 10.1136/jnnp-2024-333595.
PubMed 38744460

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
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RecruitingObservational study
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
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Not yet recruitingPhase 2
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All Relapsing-remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT03193866
Acronym / sponsor ID: COMBAT-MS / COMBAT-MS
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Immunomodulating treatment, Cohort study, Dimethyl fumarate, Fingolimod, Interferon-beta, Natalizumab, Rituximab, Glatiramer acetate
Study type: Observational
Recruitment status: Completed
Enrolment: 3,526 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, Kaiser Foundation Research Institute
Study start: 2 Jun 2017 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 21 Jun 2017 (actual)
Results: Posted 20 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 3 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients initiated at their first or second disease-modifying drug between January 1 2011 and June 30 2018 will be included in the trial. Up to present date, study-related data will be retrospectively controlled via individual study of patient records. Patients will be identified through the Swedish MS registry. Inclusion into the COMBAT-MS core study will be subject to written informed consent. Given the non-intervention design of the study and very limited study-specific procedures outside of clinical practise, we expect participation rates to be very high. Based on preliminary calculations from the MS registry the projected number of participants will be 3700 patients, out of which at least 1000 are treated with rituximab first or second-line.

Key inclusion criteria (5 listed)

The study population consists of all patients with Clinically Isolated Syndrome (CIS) or RRMS who;
Initiate a first MS DMT (treatment naïve), or Initiate a second ever DMT, of a different drug class than the first, regardless of time between drugs or reason for discontinuation("switchers") from 1st Jan 2011 to 30st June 2018, and
Are followed at any of the University clinics of Sweden, and
Consent to participation in COMBAT-MS core, and
Are expected to be capable to follow study assessments.

Key exclusion criteria (1 listed)

Patients with progressive forms of MS at start of therapy are not eligible

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RituximabAlso: Natalizumab, Fingolimod, Alemtuzumab, Interferon-betaComparisons of efficacy and safety between rituximab and all other frequently used immunomodulating drugs against multiple sclerosis	Drug	–

Primary outcome

Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline
Time frame: 3 years
Proportion of patients with baseline EDSS <2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up. Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline
Time frame: 3 years
- Proportion of patients with baseline EDSS ≥2.5 experiencing 12 months confirmed EDSS increase of 1 point among those over 3 years of follow up Expanded Disability Status Scale (EDSS) scale range: Minimum score: 0 (normal neurological examination). Maximum score: 10 (death due to multiple sclerosis) Lower scores indicate better outcomes (less disability). Higher scores indicate worse outcomes (more disability).
Disease-related Impact on Daily Life, Physical
Time frame: 3 years
- Change in the MSIS-29 physical subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) physical subscale measures patient-reported physical impact of multiple sclerosis. Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.
Disease-related Impact on Daily Life, Psychological
Time frame: 3 years
- Change in the MSIS-29 psychological subscale (change from baseline; mean value) The Multiple Sclerosis Impact Scale (MSIS-29) psychological subscale measures patient-reported psychological impact of multiple sclerosis. Scale range: Minimum score: 1 (least impact). Maximum score: 5 (highest impact). Lower scores indicate better outcomes. Higher scores indicate worse outcomes.

12 secondary outcomes

Annualized Relapse Rate
Time frame: 3 years
Remaining on Drug
Time frame: 3 years
Increase in EDSS
Time frame: 3 years
Proportion of Patients With at Least 1 Step Increase in EDSS
Time frame: 3 years
Proportion of Patients With No Evidence of Disease Activity (NEDA) -2
Time frame: 3 years
Proportion of Patients With NEDA-3
Time frame: 3 years
Quality of Life Assessments
Time frame: 3 years
Fatigue
Time frame: 3 years
Treatment Satisfaction
Time frame: 3 years
Rate of Serious Infections
Time frame: 3 years
Rate of Major Adverse Cardiovascular Events (MACE)
Time frame: 3 years
Rate of Invasive Cancer
Time frame: 3 years

Results and safety

Results posted to the registry on 20 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RTX (First Line)	591	591
IFN (First Line)	992	992
GA (First Line)	116	116
DMF (First Line)	416	416
NTZ (First Line)	334	334
RTX (Second Line)	0	0
DMF (Second Line)	0	0
NTZ (Second Line)	0	0
FGL (Second Line)	0	0
TFL (Second Line)	0	0

Primary outcome: Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline

Time frame: 3 years. Count of participants. Unit: Participants

Measure	RTX (First Line) n = 591	IFN (First Line) n = 992	GA (First Line) n = 116	DMF (First Line) n = 416	NTZ (First Line) n = 334	RTX (Second Line) n = 748	DMF (Second Line) n = 570	NTZ (Second Line) n = 541	FGL (Second Line) n = 443	TFL (Second Line) n = 161
First line	20	50	5	14	7	0	0	0	0	0
Second line	–	–	–	–	–	18	25	19	19	8

RTX (First Line) vs IFN (First Line): Difference in proportion: 1.5 (95% CI -1.8 to 4.9)
RTX (First Line) vs GA (First Line): Difference in proportion: -0.2 (95% CI -6.8 to 6.5)
RTX (First Line) vs DMF (First Line): Difference in proportion: 1.3 (95% CI -1.7 to 4.3)

Population analysed: First line and Second line reported in separate rows

Primary outcome: Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline

Time frame: 3 years. Count of participants. Unit: Participants

Measure	RTX (First Line) n = 591	IFN (First Line) n = 992	GA (First Line) n = 116	DMF (First Line) n = 416	NTZ (First Line) n = 334	RTX (Second Line) n = 748	DMF (Second Line) n = 570	NTZ (Second Line) n = 541	FGL (Second Line) n = 443	TFL (Second Line) n = 161
First line	50	111	9	30	32	–	–	–	–	–
Second line	–	–	–	–	–	50	57	47	37	9

RTX (First Line) vs IFN (First Line): Difference in proportion: 0.7 (95% CI -7.5 to 8.8)
RTX (First Line) vs GA (First Line): Difference in proportion: -2.9 (95% CI -18.5 to 12.8)
RTX (First Line) vs DMF (First Line): Difference in proportion: -0.1 (95% CI -8.8 to 8.6)

Population analysed: First line and Second line reported in separate rows

Primary outcome: Disease-related Impact on Daily Life, Physical

Time frame: 3 years. Mean (Standard Deviation). Unit: units on a scale

Measure	RTX (First Line) n = 591	IFN (First Line) n = 992	GA (First Line) n = 116	DMF (First Line) n = 416	NTZ (First Line) n = 334	RTX (Second Line) n = 748	DMF (Second Line) n = 570	NTZ (Second Line) n = 541	FGL (Second Line) n = 443	TFL (Second Line) n = 161
First line	-1.4 (16.6)	1.1 (16.2)	-4.8 (17.7)	-1.2 (16.1)	-6.3 (18.0)	–	–	–	–	–
Second line	–	–	–	–	–	-0.3 (14.5)	-0.5 (13.3)	-2.1 (16.4)	-1.3 (14.3)	2.9 (16.5)

RTX (First Line) vs IFN (First Line): Mean Difference (Net): 0.4 (95% CI -2.5 to 3.3)
RTX (First Line) vs GA (First Line): Mean Difference (Net): -4.5 (95% CI -12.5 to 3.4)
RTX (First Line) vs DMF (First Line): Mean Difference (Net): -0.3 (95% CI -2.5 to 1.8)

Population analysed: First line and Second line reported in separate rows

Primary outcome: Disease-related Impact on Daily Life, Psychological

Time frame: 3 years. Mean (Standard Deviation). Unit: units on a scale

Measure	RTX (First Line) n = 591	IFN (First Line) n = 992	GA (First Line) n = 116	DMF (First Line) n = 416	NTZ (First Line) n = 334	RTX (Second Line) n = 748	DMF (Second Line) n = 570	NTZ (Second Line) n = 541	FGL (Second Line) n = 443	TFL (Second Line) n = 161
First line	-8.5 (21.3)	-5.1 (20.7)	-23.1 (23.8)	-6.8 (20.7)	-12.2 (22.3)	–	–	–	–	–
Second line	–	–	–	–	–	-3.7 (19.5)	-1.7 (19.3)	-6.1 (20.5)	-4.7 (19.5)	-0.3 (21.8)

RTX (First Line) vs IFN (First Line): Mean Difference (Net): 2.3 (95% CI -2.2 to 6.8)
RTX (First Line) vs GA (First Line): Mean Difference (Net): -8.3 (95% CI -20.3 to 3.7)
RTX (First Line) vs DMF (First Line): Mean Difference (Net): 0.4 (95% CI -2.6 to 3.5)

Population analysed: First line and Second line reported in separate rows

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years and 9 months, during prospective data collection between 2017 and 2022. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RTX (First or Second Line)	43 of 1,184 (3.6%)	0 of 0	1 of 1,184
IFN (First Line)	1 of 884 (0.1%)	0 of 0	0 of 884
GA (First Line)	0 of 97 (0%)	0 of 0	0 of 97
DMF (First or Second Line)	1 of 870 (0.1%)	0 of 0	0 of 870
NTZ (First or Second Line)	3 of 767 (0.4%)	0 of 0	0 of 767
FGL (First Line)	3 of 384 (0.8%)	0 of 0	0 of 384
TFL (First Line)	3 of 138 (2.2%)	0 of 0	1 of 138

Limitations and caveats (from the sponsor): COMBAT was an observational real-world study assessing the outcomes of different DMTs as used according to clinical practice. The assignment of treatments was not under investigator control, there was no randomization and no blinding of treatments. Although differences in patient characteristics at treatment start was accounted for by statistical modelling, the risk of residual confounding should be kept in mind.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38744460Englund S, Frisell T, Qu Y, Gandhi K, Hulten A, Kierkegaard M, Piehl F, Longinetti E. Trajectories of self-reported fatigue following initiation of multiple sclerosis disease-modifying therapy. J Neurol Neurosurg Psychiatry. 2024 Oct 16;95(11):1012-1020. doi: 10.1136/jnnp-2024-333595.
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.

Fredrik Piehl, MD, PhD principal investigator

Karolinska Institutet

Anders Svenningsson, MD, PhD principal investigator

Karolinska Institutet

Anna Fogdell-Hahn, PhD principal investigator

Karolinska Institutet

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-remitting Multiple Sclerosis, run by Karolinska Institutet at 1 site in Sweden.

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 5 inclusion and 1 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 20 Apr 2025. 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 Sweden. 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 20 Apr 2025). 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?

Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline (time frame: 3 years). The study lists 4 primary outcomes in all. 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 NCT03193866, 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 20 Apr 2025.