N/A
Completed N=2,449
COMparison Between All immunoTherapies for Multiple Sclerosis.
Source: ClinicalTrials.gov NCT03193866 ↗Enrolled (actual)
2,449
Serious AEs
1.3%
Results posted
Apr 2025
Primary outcomePrimary: Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline — 20; 50; 5; 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline |
20; 50; 5; 14; 7; 0 | — |
| PRIMARY Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline |
50; 111; 9; 30; 32; 50 | — |
| PRIMARY Disease-related Impact on Daily Life, Physical |
-1.4; 1.1; -4.8; -1.2; -6.3; -0.3 | — |
| PRIMARY Disease-related Impact on Daily Life, Psychological |
-8.5; -5.1; -23.1; -6.8; -12.2; -3.7 | — |
| SECONDARY Annualized Relapse Rate |
0.08; 0.59; 0.47; 0.26; 0.26; 0.09 | — |
| SECONDARY Remaining on Drug |
527; 300; 40; 191; 167; 662 | — |
| SECONDARY Increase in EDSS |
-0.2; 0.1; 0.2; -0.2; -0.4; -0.0 | — |
| SECONDARY Proportion of Patients With at Least 1 Step Increase in EDSS |
108; 272; 43; 83; 44; 135 | — |
| SECONDARY Proportion of Patients With No Evidence of Disease Activity (NEDA) -2 |
483; 348; 44; 235; 208; 638 | — |
| SECONDARY Proportion of Patients With NEDA-3 |
467; 340; 43; 232; 204; 619 | — |
| SECONDARY Quality of Life Assessments |
0.77; 0.77; 0.74; 0.81; 0.76; 0.76 | — |
| SECONDARY Fatigue |
55.1; 52.1; 55.7; 48.3; 53.2; 53.5 | — |
| SECONDARY Treatment Satisfaction |
50.1; 44.3; 42.8; 48.3; 49.5; 49.5 | — |
| SECONDARY Rate of Serious Infections |
12.7; 6.8; 5.8; 9.8; 12.2; 20.2 | — |
| SECONDARY Rate of Major Adverse Cardiovascular Events (MACE) |
1.7; 1.4; 0.0; 0.8; 0.0; 1.3 | — |
| SECONDARY Rate of Invasive Cancer |
0.6; 2.4; 2.9; 0.0; 3.0; 1.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03193866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.