Trial · NCT05084638
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
NCT05084638, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2026-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. Trials, record NCT05084638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05084638
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
- NCT number
- NCT05084638
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 180 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Relapse Remitting Multiple Sclerosis
- Interventions
- Ofatumumab
- First posted
- 2021-10-20
- Last updated
- 2026-02-27
- Results first posted
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | Month 6 to month 18 | A participant is considered as achieved NEDA-3 if they were: * relapse-free, defined as no confirmed relapses in month 6 to 18. * 3-month clinical disability progression-free, defined as no clinical disability progression as measured by EDSS in month 6 to 18. * MRI activity-free, defined as no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Number of Confirmed MS Relapses in Months 6 to 18 | Month 6 to month 18 | Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS , i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. Confirmation of MS relapse was done centrally. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Participant Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | ARR (participant-based) is calculated at the participant level as \[(number of confirmed MS relapses in Months 6 to 18) / (number of days in Months 6 to 18)\] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Group Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | ARR (group-based) is calculated at the group level as \[(total number of confirmed MS relapses in Months 6 to 18 for all participants within the ofatumumab-treated cohort) / (total number of days in Months 6 to 18 for all participants within the ofatumumab-treated cohort)\] x 365.25. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Percentage of Participants That Were 3-month Disability Progression-free | Month 6 to month 18 | 3-month clinical disability progression-free was defined as no clinical disability progression as measured by EDSS (global assessment scale), where 3-month confirmed clinical disability progression was defined as an increase from Month 6 in EDSS sustained for at least 3 months. If a participant fulfilled the clinical disability progression criteria based on the single EDSS assessment at Month 18, it was considered a confirmed clinical disability progression (sustainment for at least 3 months was not required). If a participant died due to MS , it was considered a confirmed clinical disability progression regardless of the Month 6 EDSS or change in EDSS. Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | Month 6 to month 18 | A participant is considered as achieved NEDA-Clinical if the participant has not had a confirmed MS relapse in Months 6 to 18 and no 3-month confirmed clinical disability progression in Months 6 to 18 (based on change from Month 6 in EDSS). Expanded Disability Status Scale (EDSS) ranges from 0 to 10 with higher values indicating increased disability. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | Month 6 to month 18 | A participant is considered as achieved NEDA-radiological if the participant has had no Gd+ lesions on any MRI scan after Month 6, or new/enlarging T2 lesions compared to Month 6 on any MRI scan after Month 6 (MRI activity-free). Scheduled and unscheduled assessments are considered. As per protocol and SAP only evaluated on the ofatumumab participants. |
| Secondary | Change From Baseline in Gd+ Lesion Count | Baseline to Month 18 and 30 | Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in Gd+ Lesion Volume | Baseline to Month 18 and 30 | Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
| Secondary | Change From Baseline in New/Enlarging T2 Lesion Count | Baseline to Month 18 and 30 | Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | Month 6 to month 18 | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | percentage of participants | NUMBER |
| SECONDARY | Number of Confirmed MS Relapses in Months 6 to 18 | Month 6 to month 18 | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | relapses | NUMBER |
| SECONDARY | Participant Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | relapses/ participant-year | MEAN |
| SECONDARY | Group Based Annualized Relapse Rate (ARR) | Month 6 to month 18 | The Full Analysis Set (FAS) included all enrolled participants who received any study drug. | relapses/ participant-year | NUMBER |
| SECONDARY | Percentage of Participants That Were 3-month Disability Progression-free | Month 6 to month 18 | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | Month 6 to month 18 | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | Month 6 to month 18 | The Modified Full Analysis Set (mFAS) included all participants who received any study drug except for those who discontinued treatment prematurely prior to Month 18 for reasons other than lack of efficacy or death, or those who completed their Month 18 visit but missed relapse/EDSS/MRI at Month 6, 12 or 18, unless they showed disease activity. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Gd+ Lesion Count | Baseline to Month 18 and 30 | |||
| SECONDARY | Change From Baseline in Gd+ Lesion Volume | Baseline to Month 18 and 30 | |||
| SECONDARY | Change From Baseline in New/Enlarging T2 Lesion Count | Baseline to Month 18 and 30 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3) | Ofatumumab | 81.1 | 95% Confidence Interval 71.7 to 88.4 | percentage of participants | |
| Number of Confirmed MS Relapses in Months 6 to 18 | Ofatumumab | 1 | relapses | ||
| Participant Based Annualized Relapse Rate (ARR) | Ofatumumab | 0.01 | Full Range 0.0 to 1.0 | relapses/ participant-year | |
| Group Based Annualized Relapse Rate (ARR) | Ofatumumab | 0.01 | relapses/ participant-year | ||
| Percentage of Participants That Were 3-month Disability Progression-free | Ofatumumab | 90.5 | 95% Confidence Interval 82.8 to 95.6 | percentage of participants | |
| Percentage of Participants With NEDA (No Evidence of Disease Activity) - Clinical | Ofatumumab | 89.5 | 95% Confidence Interval 81.5 to 94.8 | Percentage of participants | |
| Number of Participants With NEDA (No Evidence of Disease Activity) - Radiological | Ofatumumab | 90.5 | 95% Confidence Interval 82.8 to 95.6 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ofatumumab | 119 | |
| Overall Study | STARTED | Healthy Control | 61 | |
| Overall Study | COMPLETED | Ofatumumab | 110 | |
| Overall Study | COMPLETED | Healthy Control | 34 | |
| Overall Study | NOT COMPLETED | Ofatumumab | 9 | |
| Overall Study | NOT COMPLETED | Healthy Control | 27 |
Source ClinicalTrials.gov
Adverse events96
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 |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Ofatumumab-Treated | 6 | 119 | |
| other | Abdominal pain | Gastrointestinal disorders | Healthy Control | 0 | 61 | |
| other | Nausea | Gastrointestinal disorders | Ofatumumab-Treated | 14 | 119 | |
| other | Nausea | Gastrointestinal disorders | Healthy Control | 2 | 61 | |
| other | Vomiting | Gastrointestinal disorders | Ofatumumab-Treated | 8 | 119 | |
| other | Vomiting | Gastrointestinal disorders | Healthy Control | 2 | 61 | |
| other | Chills | General disorders | Ofatumumab-Treated | 43 | 119 | |
| other | Chills | General disorders | Healthy Control | 0 | 61 | |
| other | Fatigue | General disorders | Ofatumumab-Treated | 24 | 119 | |
| other | Fatigue | General disorders | Healthy Control | 1 | 61 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ofatumumab-Treated | 0 | 119 |
| Total, all-cause mortality | Healthy Control | 0 | 61 |
| Total, other adverse events | Ofatumumab-Treated | 99 | 119 |
| Total, other adverse events | Healthy Control | 27 | 61 |
| Total, serious adverse events | Ofatumumab-Treated | 8 | 119 |
| Total, serious adverse events | Healthy Control | 3 | 61 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ofatumumab-Treated vs Healthy Control: deaths from any cause | Trial comparisons |
| Ofatumumab-Treated vs Healthy Control: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05084638
GET https://conductscience.org/api/trials/v1/NCT05084638/events?page=2