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 range18 Years

SexALL

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

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 range18 Years

SexALL

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