Trial · NCT03193866
COMparison Between All immunoTherapies for Multiple Sclerosis.
NCT03193866, Completed, Karolinska Institutet; results first posted 2025-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. COMparison Between All immunoTherapies for Multiple Sclerosis. Trials, record NCT03193866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03193866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COMparison Between All immunoTherapies for Multiple Sclerosis.
- NCT number
- NCT03193866
- Status
- Completed
- Enrollment
- 3,526 participants, actual
- Lead sponsor
- Karolinska Institutet
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Interventions
- Rituximab
- First posted
- 2017-06-21
- Last updated
- 2025-04-20
- Results first posted
- 2025-04-20
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | 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). |
| Primary | Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline | 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). |
| Primary | Disease-related Impact on Daily Life, Physical | 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. |
| Primary | Disease-related Impact on Daily Life, Psychological | 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. |
| Secondary | Annualized Relapse Rate | 3 years | \- Comparison of mean number of relapses per year between the different treatments |
| Secondary | Remaining on Drug | 3 years | \- Proportion remaining on the index DMT after 3 years |
| Secondary | Increase in EDSS | 3 years | \- 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). |
| Secondary | Proportion of Patients With at Least 1 Step Increase in EDSS | 3 years | \- 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). |
| Secondary | Proportion of Patients With No Evidence of Disease Activity (NEDA) -2 | 3 years | \- 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. |
| Secondary | Proportion of Patients With NEDA-3 | 3 years | \- 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Confirmed Disease Progression in Patients With EDSS ≥2.5 at Baseline | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease-related Impact on Daily Life, Physical | 3 years | First line and Second line reported in separate rows | units on a scale | MEAN |
| PRIMARY | Disease-related Impact on Daily Life, Psychological | 3 years | First line and Second line reported in separate rows | units on a scale | MEAN |
| SECONDARY | Annualized Relapse Rate | 3 years | First line and Second line reported in separate rows | percentage of relapses | MEAN |
| SECONDARY | Remaining on Drug | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Increase in EDSS | 3 years | First line and Second line reported in separate rows | units on a scale | MEAN |
| SECONDARY | Proportion of Patients With at Least 1 Step Increase in EDSS | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With No Evidence of Disease Activity (NEDA) -2 | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With NEDA-3 | 3 years | First line and Second line reported in separate rows | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | RTX (First Line) | First line | 20 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | IFN (First Line) | First line | 50 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | GA (First Line) | First line | 5 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | DMF (First Line) | First line | 14 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | NTZ (First Line) | First line | 7 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | RTX (Second Line) | First line | 0 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | DMF (Second Line) | First line | 0 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | NTZ (Second Line) | First line | 0 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | FGL (Second Line) | First line | 0 | Participants | |
| Confirmed Disease Progression in Patients With Expanded Disability Status Scale (EDSS) <2.5 at Baseline | TFL (Second Line) | First line | 0 | Participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Line | STARTED | RTX (First Line) | 591 | 591 |
| First Line | STARTED | IFN (First Line) | 992 | 992 |
| First Line | STARTED | GA (First Line) | 116 | 116 |
| First Line | STARTED | DMF (First Line) | 416 | 416 |
| First Line | STARTED | NTZ (First Line) | 334 | 334 |
| First Line | STARTED | RTX (Second Line) | 0 | 0 |
| First Line | STARTED | DMF (Second Line) | 0 | 0 |
| First Line | STARTED | NTZ (Second Line) | 0 | 0 |
| First Line | STARTED | FGL (Second Line) | 0 | 0 |
| First Line | STARTED | TFL (Second Line) | 0 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events273
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | RTX (First or Second Line) | 6 | 1,184 | 6 |
| serious | Pneumonia | Infections and infestations | IFN (First Line) | 0 | 884 | 0 |
| serious | Pneumonia | Infections and infestations | GA (First Line) | 0 | 97 | 0 |
| serious | Pneumonia | Infections and infestations | DMF (First or Second Line) | 0 | 870 | 0 |
| serious | Pneumonia | Infections and infestations | NTZ (First or Second Line) | 0 | 767 | 0 |
| serious | Pneumonia | Infections and infestations | FGL (First Line) | 0 | 384 | 0 |
| serious | Pneumonia | Infections and infestations | TFL (First Line) | 0 | 138 | 0 |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | RTX (First or Second Line) | 0 | 1,184 | 0 |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | IFN (First Line) | 0 | 884 | 0 |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | GA (First Line) | 0 | 97 | 0 |
1 to 10 of 273Source ClinicalTrials.gov
See all 273 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RTX (First or Second Line) | 1 | 1,184 |
| Total, all-cause mortality | IFN (First Line) | 0 | 884 |
| Total, all-cause mortality | GA (First Line) | 0 | 97 |
| Total, all-cause mortality | DMF (First or Second Line) | 0 | 870 |
| Total, all-cause mortality | NTZ (First or Second Line) | 0 | 767 |
| Total, all-cause mortality | FGL (First Line) | 0 | 384 |
| Total, all-cause mortality | TFL (First Line) | 1 | 138 |
| Total, other adverse events | RTX (First or Second Line) | 0 | 0 |
| Total, other adverse events | IFN (First Line) | 0 | 0 |
| Total, other adverse events | GA (First Line) | 0 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38744460 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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