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Active, not recruitingNCT07821411Updated Oct 20, 2026

A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan

An observational study in Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational

Updated Oct 20, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,000
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 107 studies in Multiple Sclerosis by Novartis — 9 open to participants now, 25 under way, 7 of them phase 3. Multiple Sclerosis · Novartis.

Planned enrollment
2nd of 41
5,000 · median 312
Started
2026
with 3 others
Observational
41 of 107
7 open now
Primary completion
2026-11
later than 8 of 24 live
Registered
106th of 107
by date

Among the 107 studies in Multiple Sclerosis by Novartis, this one is the 2nd largest by planned enrollment of the 41 observational ones that give a count, is one of 4 that started in 2026, is one of 41 observational ones, reaches primary completion later than 8 of the 24 other live ones, and was the 106th registered.

Multiple Sclerosis

3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.

Browse Multiple Sclerosis studies →

Open to participants now

9 of the 107 studies in Multiple Sclerosis by Novartis are open now, in 12 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Who these studies take

Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 107 studies in Multiple Sclerosis by Novartis, or all of them as a file.
02

Study summary

This study aims to evaluate the real-world persistence and adherence to ofatumumab (OMB) treatment in adult patients with relapsing multiple sclerosis (RMS). This is a non-interventional study using administrative claims data available in Germany and Japan.

03

Conditions studied

  • Multiple Sclerosis

Browse trials for

Keywords

  • Persistence
  • Adherence
  • Real world data
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult RMS patients who start new treatment with OMB or a DMT.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients will be included in the OMB or disease modifying treatment (DMT) cohort if they meet the following criteria:

  • Have an RMS diagnosis including relapsing-remitting multiple sclerosis (RRMS) or active secondary progressive multiple sclerosis (SPMS).
  • Have a new start of OMB or DMT during the inclusion period (any time on or after the RMS diagnosis index date) that was not used during the baseline period (patients may be DMT-naïve or switch to new DMT).
  • Age 18 years or older at index date. Index date is the date of first claim for OMB or DMT during the inclusion period.
  • Have a continuous health plan enrollment from the start of the baseline period to 12 months after index date (excluding early death).

Exclusion criteria

Exclusion criteria:

Patients will be excluded if they meet any of the following criteria:

  • Have inactive SPMS or primary progressive multiple sclerosis (PPMS).
  • Have any inpatient or outpatient diagnosis of other demyelinating diseases during the baseline period.

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • OMB Cohort

    Adult patients diagnosed with RMS and newly treated with OMB.

  • OMB Treatment Naïve (OMBn) Cohort

    A sub-group of the OMB Cohort. Patients with no record of treatment with a DMT before starting OMB treatment.

  • OMB Treatment Switch (OMBs) Cohort

    A sub-group of the OMB Cohort. Patients who used at least one DMT before starting OMB treatment.

  • DMT Cohort

    Adult patients diagnosed with RMS who began new treatment with a DMT and had no record of treatment with OMB.

  • Low Efficacy Treatment (LET) Cohort

    A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an LET.

  • LET Treatment Naïve (LETn) Cohort

    A sub-group of the LET Cohort. Patients with no record of a DMT before staring an LET.

  • LET Treatment Switch (LETs) Cohort

    A sub-group of the LET Cohort. Patients who used at least one DMT before starting an LET.

  • Medium Efficacy Treatment (MET) Cohort

    A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is an MET.

  • MET Treatment Naïve (METn) Cohort

    A sub-group of the MET Cohort. Patients with no record of a DMT before staring an MET.

  • MET Treatment Switch (METs) Cohort

    A sub-group of the MET Cohort. Patients who used at least one DMT before starting an MET.

  • High Efficacy Treatment (HET) Cohort

    A sub-group of the DMT Cohort. Patients whose first DMT prescribed during the inclusion period is a HET.

  • HET Treatment Naïve (HETn) Cohort

    A sub-group of the HET Cohort. Patients with no record of a DMT before starting a HET.

  • HET Treatment Switch (HETs) Cohort

    A sub-group of the HET Cohort. Patients who used at least one DMT before starting a HET.

06

What researchers measure

Primary outcomes

  1. Proportion of Patients Persistent With OMB

    Persistence is defined as the absence of evidence of treatment switch or discontinuation at pre-defined timepoints of interest (6 months, 12 months follow-up).

    Time frame: 6 months, 12 months

  2. Proportion of Patients Adherent to OMB

    Adherence measured using the proportion of days covered (PDC). PDC is defined as the number of days covered by the treatment divided by the period considered in the analysis, including overlaps between prescriptions.

    Time frame: 6 months, 12 months

Secondary outcomes

  1. Number of Treatments Used

    Time frame: Baseline, up to approximately 4 years

  2. Number of Patients by Sequence of Treatments Used

    Time frame: Baseline, up to approximately 4 years

  3. Number of Patients by Line of Therapy (LOT)

    Time frame: Baseline, up to approximately 4 years

  4. Number of Patients by Type of Treatment

    Time frame: Baseline, up to approximately 4 years

  5. Duration of Treatment

    Time frame: Baseline, up to approximately 4 years

  6. Percentage of Patients Who Switch Treatment

    Percentage of patients who switch from OMB treatment to another DMT.

    Time frame: Up to approximately 4 years

  7. Percentage of Patients Who Discontinue OMB Treatment

    Time frame: Up to approximately 4 years

  8. Number of Patients by Treatments Received After OMB Treatment

    Time frame: Up to approximately 4 years

  9. Baseline Demographics

    Time frame: Baseline

  10. Number of Patients by Index Year

    Index year is the year of index date. Index date is the date of first claim for OMB or DMT.

    Time frame: Baseline

  11. Charlson Comorbidity Index (CCI) Score

    CCI is a weighted index that takes into account both the number and the seriousness of comorbid diseases. It predicts the ten-year mortality for a patient who may have a range of comorbid conditions. CCI can be classified as low (0-1) and high (≥2).

    Time frame: Baseline

  12. Number of Patients per Top 10 Comorbidities Observed During the Baseline Period

    Time frame: Baseline

  13. Frequency of at least One All-cause and MS-specific Hospitalization During the Baseline Period

    Time frame: Baseline

  14. Number of Hospitalizations Per Person Year

    RMS-specific and all-cause hospitalizations.

    Time frame: Baseline

  15. Number of Relapses Per Person Year

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Sep 2026 → Nov 2026 and completion Sep 2026 → Nov 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2026
First posted
Sep 15, 2026
StartActual
Jul 31, 2026
Primary completionEst.
Nov 30, 2026was Sep 2026
CompletionEst.
Nov 30, 2026was Sep 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 30, 2026→Nov 30, 2026
Oct 20, 2026
Study completion
Sep 30, 2026→Nov 30, 2026
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Primary completion Sep 30, 2026→Nov 30, 2026
    Study completion Sep 30, 2026→Nov 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07821411
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Jul 31, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Oct 20, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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