Multiple SclerosisMS-PEKOSNCT06668324
Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study aimed to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 5 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MS who were prescribed and initiating OMB or OCR SC and who were living in the US at the time of the survey were invited to participate following a referral from their healthcare providers
Who may be able to join
- Ability to use a mobile device or computer with broadband internet access (or data streaming available)
- Ability to read, understand, and respond in English
- Adult aged 18 years of age or over at the time of the survey
- Self-confirmed diagnosis of MS
- Prescribed either OMB or OCR SC and received their first injection (Day 0) and completed the study survey between Day 1 and Day 7
Who cannot join
- Participated in an OMB or OCR randomized clinical trial
- Previously treated with OMB or OCR SC
- Cognitive impairment that impacts the patient's ability to participate in a survey study
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)
The study aimed to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ofatumumab | Not described | |
| ocrelizumab SC formulation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reported local injection-related reaction post first injection
Proportion of patients reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
Measured: Day 1-7 post first injection, at the time of survey completion
Secondary outcomes (1)
Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)
Proportion of patients in a 5-Likert scale (extremely dissatisfied, dissatisfied, neutral, satisfied, and extremely satisfied) for satisfaction on injection-related experience
Measured: Day 1-7 post first injection, at the time of survey completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Nov 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668324
- Sponsor's protocol ID
- COMB157AUS25
- Acronym
- MS-PEKOS
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)
- ClinicalTrials.gov ID
- NCT06668324
- Acronym / sponsor ID
- MS-PEKOS / COMB157AUS25
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ofatumumab | – | – |
| ocrelizumab SC formulation | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS who were prescribed and initiating OMB or OCR SC and who were living in the US at the time of the survey were invited to participate following a referral from their healthcare providers
Key inclusion criteria (5 listed)
- Ability to use a mobile device or computer with broadband internet access (or data streaming available)
- Ability to read, understand, and respond in English
- Adult aged 18 years of age or over at the time of the survey
- Self-confirmed diagnosis of MS
- Prescribed either OMB or OCR SC and received their first injection (Day 0) and completed the study survey between Day 1 and Day 7
Key exclusion criteria (3 listed)
- Participated in an OMB or OCR randomized clinical trial
- Previously treated with OMB or OCR SC
- Cognitive impairment that impacts the patient's ability to participate in a survey study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients reported local injection-related reaction post first injection
Time frame: Day 1-7 post first injection, at the time of survey completion
Proportion of patients reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
1 secondary outcome
Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)
Time frame: Day 1-7 post first injection, at the time of survey completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reported local injection-related reaction post first injection (time frame: Day 1-7 post first injection, at the time of survey completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.