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This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.
This was a four cohort, multicenter, open-label, prospective study of 34 (optionally up to 60) patients who had relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination (initial vaccinations or booster vaccines) as part of clinical routine. The maximal duration of the study for an individual patient was 22 months.
Cohort 1a - Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment.
Cohort 1b - Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment.
Cohort 2a - Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
Cohort 2b - Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies were investigated for up to 18 months after the participants' vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. |
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| Cohort 1b | Experimental | Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment. |
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| Cohort 2a | Experimental | Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
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| Cohort 2b | Experimental | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. | 1 month after second dose of vaccine or booster vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Participants who maintained detectable SARS-CoV-2 reactive T-cells (measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix) after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment. First booster vaccination was optional for cohorts 1a and 2a. In cohorts 1b and 2b the time points "Month 1 after Vacc" and "1 Month after booster" are identical. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 13353 | Germany | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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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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Thirty-seven participants were screened and 34 participants met the criteria for entry into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a | Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. |
| FG001 | Cohort 1b | Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2022 | Jun 5, 2024 |
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| At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster |
| Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | Patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. The fold change of SI from last value before booster to Month 1 is the ratio of SI at Month 1 divided by SI at last value before booster. | Last value before booster to 1 month after booster |
| Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Level of SARS-CoV-2 serum functional antibodies were measured by a central laboratory using a neutralizing antibody detection kit. | Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster |
| SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Phenotypic description of the cellular immune response was performed at the central laboratory. T-cells were stimulated with SARS-CoV-2 peptide mix and analyzed for IFNg- and IL4 secretion using FACS analysis. | Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine |
| Bielefeld |
| D 33647 |
| Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Erbach im Odenwald | 64711 | Germany |
| Novartis Investigative Site | Siegen | 57076 | Germany |
| Novartis Investigative Site | Unterhaching | 82008 | Germany |
| FG002 | Cohort 2a | Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| FG003 | Cohort 2b | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a | Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. |
| BG001 | Cohort 1b | Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatment. |
| BG002 | Cohort 2a | Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| BG003 | Cohort 2b | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Having Established SARS-CoV-2-specific T Cells After Receiving a modRNA Vaccine | Participants who established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either 1 month after second dose of vaccine or 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. | Efficacy and safety analysis sets | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after second dose of vaccine or booster vaccine |
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| Secondary | Percentage of Participants Who Maintained T-cell Response After Receiving a modRNA Vaccine | Participants who maintained detectable SARS-CoV-2 reactive T-cells (measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix) after second dose of vaccine or 6 and 12 months after booster vaccine in participants who received the vaccine before or after starting ofatumumab treatment. First booster vaccination was optional for cohorts 1a and 2a. In cohorts 1b and 2b the time points "Month 1 after Vacc" and "1 Month after booster" are identical. | Efficacy and safety analysis sets | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 1, Months 6, 12 and 18 after second dose of vaccine or 1 Month after 1st booster, 1 Month after 2nd booster |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Increase in Specific T-cells After Receiving an modRNA Booster Vaccine | Patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. ELIspot assay from T-cells that were stimulated with SARS-CoV-2 peptide mix 1 month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment. The fold change of SI from last value before booster to Month 1 is the ratio of SI at Month 1 divided by SI at last value before booster. | All patients in the efficacy analysis set, for whom ELISpot data for the time points "last visit before booster" and "month 1 after booster" were available, were included in the analysis. | Posted | Mean | Standard Deviation | fold change | Last value before booster to 1 month after booster |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of RMS Participants With Quantifiable Levels of SARS-CoV-2 Serum Functional Antibodies by Visits and Subcohorts (EAS) | Level of SARS-CoV-2 serum functional antibodies were measured by a central laboratory using a neutralizing antibody detection kit. | Efficacy analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 1 after Vacc, Month 1, 6, 12 after Vacc, 1 month after 1st booster, 1 month after 2nd booster |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | SARS-CoV-2 Specific CD4+ Effector Memory T-cells | Phenotypic description of the cellular immune response was performed at the central laboratory. T-cells were stimulated with SARS-CoV-2 peptide mix and analyzed for IFNg- and IL4 secretion using FACS analysis. | Full analysis set -available participant data varied across time points. In alignment with the secondary study objectives of the protocol and the corresponding statistical analysis plan, the phenotypical parameters were assessed by cohort. Therefore, participants in the subcohorts 1a/1b and 2a/2b were combined. | Posted | Mean | Standard Deviation | % of CD4+/CD8+ cells | Baseline, Months 1 ,6, 12 and 18 after vaccinationse of vaccine or 1,6 and 12 months after booster vaccine |
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Adverse events were reported from first dose of study treatment until the end of the treatment period plus an additional 30 day safety follow up period for a maximum time of 22 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1a | Patients received first SARS-CoV-2 vaccination within the study prior to starting ofatumumab treatment. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG001 | Cohort 1b | Patients had already completed initial vaccination cycle and received a booster vaccine within the study prior to starting ofatumumab treatmen | 0 | 8 | 0 | 8 | 6 | 8 |
| EG002 | Cohort 2a | Patients who received their first SARS-CoV-2 vaccination within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). | 0 | 5 | 1 | 5 | 5 | 5 |
| EG003 | Cohort 2b | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose) | 0 | 15 | 1 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Swelling face | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Vaccination site reaction | General disorders | MedDRA (23.1) | Systematic Assessment |
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| Immune-mediated adverse reaction | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Meralgia paraesthetica | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Multiple sclerosis | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Peripheral nerve lesion | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (23.1) | Systematic Assessment |
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| Adjustment disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Breast mass | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
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Immunophenotyping (outcome measure 5) was inconclusive due to low participant numbers.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2023 | Jun 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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| Male |
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| Missing |
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| OG003 | Cohort 2b | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| OG004 | Total | All cohorts |
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| OG003 | Cohort 2b | Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose). |
| OG004 | Total | All cohorts |
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Patients who had already completed their initial vaccination cycle and received a booster vaccine within the study while already stable on ofatumumab treatment for at least 4 weeks (since the first dose).
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