Relapsing Multiple SclerosisPhase 4NCT04667117

A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

A Phase 4 study testing Quadrivalent influenza vaccine, Ofatumumab and iDMT in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing Multiple Sclerosis
What is being tested?: Quadrivalent influenza vaccine, Ofatumumab and iDMT
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 3 sitesUnited States
Study dates: 14 Jan 2021to 6 Jul 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Signed informed consent must be obtained prior to participation in the study
Age 18-55 years old
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Must be willing to comply with the study schedule
Planning to receive a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
Planning to start treatment with ofatumumab or already on commercially prescribed ofatumumab for at least 2 weeks prior to the screening visit
Participants in Cohort 3 must fulfill criteria 1-5 above in addition to the following:
Participant must currently be receiving iDMT

Who cannot join

Already has received the 2020-2021, 2021-2022, or 2022-2023 season influenza vaccine
Known hypersensitivity to any component of the influenza vaccine
Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to Week 0
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to or oral antibiotics within two weeks prior to Week 0
Known clinical diagnosis of influenza infection during the 2020-2021 influenza season prior to starting the study based on investigator's or subject's personal physician's judgement (laboratory report of confirmed influenza infection is not required)
Prior treatment with B-cell targeted therapies (e.g., rituximab or ocrelizumab), lymphocyte-trafficking blockers, alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, bone marrow transplantation. Treatment with a natalizumab within 6 months of week 0

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Treatment with an S1P modulator within 60 days prior to Week 0
Participants with any known active systemic bacterial, fungal or viral or fungal infections (such as hepatitis, progressive multifocal leukocencephalopathy, COVID-19 or HIV), or known to have acquired immunodeficiency syndrome (AIDS)
Participation in another interventional clinical trial within 14 days prior to the screening visit
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
Women of child-bearing potential
Patients with a history of Guillain-Barre syndrome within 6 weeks of receiving the influenza vaccination.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Infinity Clinical Research LLC
Hollywood, Florida, 33024
Hope Research Institute Center Neurology and Spine
Phoenix, Arizona, 85018
The MS Center for Innovation in Care
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

Read the detailed description

Vaccinations against influenza are an important part of effective management of multiple sclerosis (MS).

Ofatumumab is a human anti-CD20 monoclonal antibody (mAb) which depletes B-cells, a component of the immune system. This study investigates if ofatumumab treated patients can have an immune response that may be protective after receiving the influenza vaccine.

There were 3 study periods:

Screening Period of up to 1 week to assess eligibility requirements.
Investigational Period of 4 weeks All participants received an inactivated influenza vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.

Participants in Cohort 1 received loading doses of 20 mg ofatumumab administered subcutaneously (s.c.) at Weeks 2, 3, and 4.

Participants in Cohort 2 continued taking their prescribed ofatumumab as per their dosing schedule throughout the Investigational Period.

Participants in Cohort 3 continued administration of their prescribed injectable disease modifying therapy (iDMT) as per their dosing schedule in the Investigational Period.

Optional, 6-month open-label Extension Period Participants in Cohort 1 were administered their first dose of ofatumumab at Week 6; thereinafter, they continued monthly dosing until the final dose at Week 26.

Participants in Cohort 2 continued to receive ofatumumab monthly until the final dose at Week 28.

Participants in Cohort 3 did not enter the open-label Extension Period.

Conditions: Relapsing Multiple Sclerosis
Being tested: Quadrivalent influenza vaccine, Ofatumumab, iDMT
Keywords: ofatumumab, 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.

Quadrivalent influenza vaccineBiological
2020-2021, 2021-2022, or 2022-2023 inactivated quadrivalent influenza vaccine. Participants received the vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.
OfatumumabDrug
Auto-injector containing 20 mg ofatumumab (20 mg/0.4mL) for subcutaneous (s.c.) administration.
- Participants in Cohort 1 received loading doses of 20 mg ofatumumab s.c. at Weeks 2, 3, and 4 in the Investigational Period. In the open-label Extension Period, they administered the first dose of ofatumumab at Week 6 and continued monthly dosing until the final dose at Week 26. Novartis supplied participants in Cohort 1 with ofatumumab treatment.
- Participants in Cohort 2 continued on their commercially prescribed ofatumumab treatment during the Investigational Period. In the open-label Extension Period, they continued to administer ofatumumab monthly until the final dose at Week 28. Cohort 2 participants in the extension could have either remained on their prescribed ofatumumab or switched to study supplied ofatumumab.
iDMTDrug
Participants in Cohort 3 continued on their commercially prescribed injectable disease modifying therapy (iDMT) during the Investigational Period.

Study groups in NCT04667117
Study group	Role	What they receive
Cohort 1	Experimental	Patients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start Receives: Biological: Quadrivalent influenza vaccine; Drug: Ofatumumab
Cohort 2	Experimental	Patients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start Receives: Biological: Quadrivalent influenza vaccine; Drug: Ofatumumab
Cohort 3	Active comparator	Patients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine Receives: Biological: Quadrivalent influenza vaccine; Drug: iDMT

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case)
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.
Measured: Week 4
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation)
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.
Measured: Week 4

Secondary outcomes (4)

Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case)
Seroconversion was defined as: • a ≥ 4-fold increase in HI titers after vaccination (in participants with pre-vaccination HI titers ≥ 10) OR • post-vaccination HI titers ≥ 40 (in participants with pre-vaccination HI titers < 10) Seroconversion against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.
Measured: Baseline (pre-vaccination), Week 4
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation)
Seroconversion was defined as: • a ≥ 4-fold increase in HI titers after vaccination (in participants with pre-vaccination HI titers ≥ 10) OR • post-vaccination HI titers ≥ 40 (in participants with pre-vaccination HI titers < 10) Seroconversion against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.
Measured: Baseline (pre-vaccination), Week 4
Fold Change From Baseline in Hemagglutination Inhibition Titers
Hemagglutination inhibition (HI) antibody titers were measured in serum samples pre-vaccination (baseline) and post-vaccination (Week 4). The geometric mean of the ratio of post-vaccination to pre-vaccination HI titer was calculated to estimate the average fold change in HI titer after vaccination compared to before vaccination.
Measured: Baseline (pre-vaccination), Week 4
Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
Number of participants with adverse events (any AEs regardless of seriousness), AEs leading to study drug discontinuation and serious adverse events (SAEs). On-study AEs are defined as AEs which started or worsened on or after the date of the visit at Week 0.
Measured: From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 20216 Jul 2023

First posted14 Dec 2020
Study start14 Jan 2021
Primary completion6 Jul 2023
Study completion6 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsing 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Parallel, prospective study
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04667117
Sponsor's protocol ID: COMB157GUS12
Status last verified: Oct 2024
First submitted: 8 Dec 2020
Last updated: 9 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/

Publications

Steingo B, Subei A, Riser E, Gitt J, Stankiewicz J, Piccolo R, Wyse K, Weinstock-Guttman B. Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study. Mult Scler Relat Disord. 2025 May;97:106382. doi: 10.1016/j.msard.2025.106382. Epub 2025 Mar 8.
PubMed 40107181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Relapsing Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously
ClinicalTrials.gov ID: NCT04667117
Acronym / sponsor ID: COMB157GUS12
Conditions: Relapsing Multiple Sclerosis
Keywords: ofatumumab, multiple sclerosis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 14 Jan 2021 (actual)
Primary completion: 6 Jul 2023 (actual)
Study completion: 6 Jul 2023 (actual)
First posted: 14 Dec 2020 (actual)
Results: Posted 1 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Vaccinations against influenza are an important part of effective management of multiple sclerosis (MS).

There were 3 study periods:

Screening Period of up to 1 week to assess eligibility requirements.
Investigational Period of 4 weeks All participants received an inactivated influenza vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.

Participants in Cohort 1 received loading doses of 20 mg ofatumumab administered subcutaneously (s.c.) at Weeks 2, 3, and 4.

Participants in Cohort 2 continued taking their prescribed ofatumumab as per their dosing schedule throughout the Investigational Period.

Participants in Cohort 3 continued administration of their prescribed injectable disease modifying therapy (iDMT) as per their dosing schedule in the Investigational Period.

Optional, 6-month open-label Extension Period Participants in Cohort 1 were administered their first dose of ofatumumab at Week 6; thereinafter, they continued monthly dosing until the final dose at Week 26.

Participants in Cohort 2 continued to receive ofatumumab monthly until the final dose at Week 28.

Participants in Cohort 3 did not enter the open-label Extension Period.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Parallel, prospective study

Arm	Type	Receives
Cohort 1	Experimental	Biological: Quadrivalent influenza vaccine, Drug: OfatumumabPatients with relapsing multiple sclerosis (MS) receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine two weeks prior to ofatumumab start
Cohort 2	Experimental	Biological: Quadrivalent influenza vaccine, Drug: OfatumumabPatients with relapsing MS receiving a 2020-2021, 2021-2022, 2022-2023 inactivated influenza vaccine at least 4 weeks after ofatumumab start
Cohort 3	Active comparator	Biological: Quadrivalent influenza vaccine, Drug: iDMTPatients with relapsing MS currently on iDMT receiving a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Signed informed consent must be obtained prior to participation in the study
Age 18-55 years old
Diagnosis of relapsing MS by 2017 revised McDonald criteria
Must be willing to comply with the study schedule
Planning to receive a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine

Key exclusion criteria (12 listed)

Already has received the 2020-2021, 2021-2022, or 2022-2023 season influenza vaccine
Known hypersensitivity to any component of the influenza vaccine
Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to Week 0
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to or oral antibiotics within two weeks prior to Week 0
Known clinical diagnosis of influenza infection during the 2020-2021 influenza season prior to starting the study based on investigator's or subject's personal physician's judgement (laboratory report of confirmed influenza infection is not required)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quadrivalent influenza vaccine2020-2021, 2021-2022, or 2022-2023 inactivated quadrivalent influenza vaccine. Participants received the vaccine within 9 calendar days after the Screening Visit, before the Week 0 Visit occurred.	Biological	Cohort 1, Cohort 2, Cohort 3
OfatumumabAuto-injector containing 20 mg ofatumumab (20 mg/0.4mL) for subcutaneous (s.c.) administration. * Participants in Cohort 1 received loading doses of 20 mg ofatumumab s.c. at Weeks 2, 3, and 4 in the Investigational Period. In the open-label Extension Period, they administered the first dose of ofatumumab at Week 6 and continued monthly dosing until the final dose at Week 26. Novartis supplied participants in Cohort 1 with ofatumumab treatment. * Participants in Cohort 2 continued on their commercially prescribed ofatumumab treatment during the Investigational Period. In the open-label Extension Period, they continued to administer ofatumumab monthly until the final dose at Week 28. Cohort 2 participants in the extension could have either remained on their prescribed ofatumumab or switched to study supplied ofatumumab.	Drug	Cohort 1, Cohort 2
iDMTParticipants in Cohort 3 continued on their commercially prescribed injectable disease modifying therapy (iDMT) during the Investigational Period.	Drug	Cohort 3

Primary outcome

Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case)
Time frame: Week 4
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.
Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation)
Time frame: Week 4
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. Non-responder imputation (NRI) for missing data was applied.

4 secondary outcomes

Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case)
Time frame: Baseline (pre-vaccination), Week 4
Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation)
Time frame: Baseline (pre-vaccination), Week 4
Fold Change From Baseline in Hemagglutination Inhibition Titers
Time frame: Baseline (pre-vaccination), Week 4
Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
Time frame: From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3)

Results and safety

Results posted to the registry on 1 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	22	22
Cohort 2	22	21
Cohort 3	19	18

Primary outcome: Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case)

Time frame: Week 4. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1 n = 18	Cohort 2 n = 22	Cohort 3 n = 17
Influenza A Brisbane	100.00 (47.82 to 100.00)	100.00 (15.81 to 100.00)	100.00 (2.50 to 100.00)
Influenza A Cambodia	100.00 (75.29 to 100.00)	80.00 (28.36 to 99.49)	85.71 (42.13 to 99.64)
Influenza A Kansas	100.00 (47.82 to 100.00)	100.00 (15.81 to 100.00)	100.00 (2.50 to 100.00)
Influenza A Michigan	100.00 (47.82 to 100.00)	100.00 (15.81 to 100.00)	100.00 (2.50 to 100.00)
Influenza A Singapore	100.00 (47.82 to 100.00)	100.00 (15.81 to 100.00)	100.00 (2.50 to 100.00)
Influenza A Victoria	100.00 (75.29 to 100.00)	100.00 (47.82 to 100.00)	100.00 (59.04 to 100.00)
Influenza A Wisconsin	61.54 (31.58 to 86.14)	40.00 (19.12 to 63.95)	68.75 (41.34 to 88.98)
Influenza B Colorado	60.00 (14.66 to 94.73)	50.00 (1.26 to 98.74)	100.00 (2.50 to 100.00)

Population analysed: Participants in the Safety Set with an available value for the outcome measure. Safety Set included all participants who had received inactivated influenza vaccine and at last 1 dose of study drug. For each influenza strain, the number of participants analyzed corresponds to the participants with both pre-vaccination and post-vaccination HI titers for the corresponding strain.

Primary outcome: Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation)

Time frame: Week 4. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1 n = 22	Cohort 2 n = 22	Cohort 3 n = 19
Influenza A Brisbane	55.56 (21.20 to 86.30)	66.67 (9.43 to 99.16)	100.00 (2.50 to 100.00)
Influenza A Cambodia	86.67 (59.54 to 98.34)	80.00 (28.36 to 99.49)	66.67 (29.93 to 92.51)
Influenza A Kansas	55.56 (21.20 to 86.30)	66.67 (9.43 to 99.16)	100.00 (2.50 to 100.00)
Influenza A Michigan	55.56 (21.20 to 86.30)	66.67 (9.43 to 99.16)	100.00 (2.50 to 100.00)
Influenza A Singapore	55.56 (21.20 to 86.30)	66.67 (9.43 to 99.16)	100.00 (2.50 to 100.00)
Influenza A Victoria	86.67 (59.54 to 98.34)	100.00 (47.82 to 100.00)	77.78 (39.99 to 97.19)
Influenza A Wisconsin	53.33 (26.59 to 78.73)	40.00 (19.12 to 63.95)	61.11 (35.75 to 82.70)
Influenza B Colorado	33.33 (7.49 to 70.07)	33.33 (0.84 to 90.57)	100.00 (2.50 to 100.00)

Population analysed: Safety Set including all participants who had received inactivated influenza vaccine and at last 1 dose of study drug. For each influenza strain, the number of participants analyzed corresponds to the participants with pre-vaccination HI titers for the corresponding strain.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Week 0 to Week 26 (Cohort 1), Week 28 (Cohort 2) and Week 4 (Cohort 3). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	0 of 22 (0%)	16 of 22 (72.7%)	0 of 22
Cohort 2	1 of 22 (4.5%)	6 of 22 (27.3%)	0 of 22
Cohort 3	0 of 19 (0%)	2 of 19 (10.5%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40107181Steingo B, Subei A, Riser E, Gitt J, Stankiewicz J, Piccolo R, Wyse K, Weinstock-Guttman B. Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study. Mult Scler Relat Disord. 2025 May;97:106382. doi: 10.1016/j.msard.2025.106382. Epub 2025 Mar 8.
A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/

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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quadrivalent influenza vaccine, Ofatumumab and iDMT in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 3 sites 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 8 inclusion and 12 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 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667117, which also lists 1 linked publication.

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 9 Oct 2024.