CompletedNot Applicable

COMparison Between All immunoTherapies for Multiple Sclerosis.

Sweden3,526 participantsStarted 2017-06-02

Plain-language 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) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: \- Patients with progressive forms of MS at start of therapy are not eligible

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 years

Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline

Timeframe: 3 years

Disease-related Impact on Daily Life, Physical

Timeframe: 3 years

Disease-related Impact on Daily Life, Psychological

Timeframe: 3 years

Trial details

NCT IDNCT03193866

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-31

Results submitted2023-09-11

View on ClinicalTrials.gov More Relapsing-remitting Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 3 years

Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline

Timeframe: 3 years

Disease-related Impact on Daily Life, Physical

Timeframe: 3 years

Disease-related Impact on Daily Life, Psychological

Timeframe: 3 years