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Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.
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This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants. The study was intended to address two questions: 1) Can participants treated with ofatumumab develop an immune response if receiving a COVID-19 mRNA vaccine two weeks prior to ofatumumab start? 2) If receiving COVID-19 mRNA vaccine after introduction of ofatumumab treatment, can participants develop an immune response? Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start. Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab. Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine. Cohort 4: participants fully vaccinated with an RNA COVID-19 vaccine at least four weeks after ofatumumab start. Cohort 5: participants vaccinated with an RNA COVID-19 vaccine, with or without a booster dose, and on interferon or glatiramer acetate. Cohort 6: participants fully vaccinated with an RNA COVID-19 vaccine who received a booster dose at least four weeks after ofatumumab start. Participants obtained the COVID-19 mRNA vaccine from their HCP (private insurance) or appropriate federal, state or local program.
Participants in Cohort 1 received loading doses of ofatumumab and subsequent dosing was 20 mg s.c. administered monthly. All other cohorts continued current dosing schedule of either ofatumumab, glatiramer acetate or interferon. Participation in trial was maximum of 421 days which was dependent on the Cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - 2 WKs vaccine prior to OMB157 | Experimental | Participants received non-live COVID-19 mRNA vaccine at least two weeks prior to start of ofatumumab (OMB157) (20 mg subcutaneous). |
|
| Cohort 2 - vaccine 4 WKs after OMB157 | Experimental | Participants received non-live COVID-19 mRNA vaccine at least four weeks after start of ofatumumab (OMB157) (20 mg subcutaneous). |
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| Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after | Active Comparator | Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate |
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| Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs | Experimental | Participants fully vaccinated with a non-live COVID mRNA vaccine and on ofatumumab for at least 4 weeks (20 mg subcutaneous) |
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| Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Drug | 3 loading doses followed by monthly administrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Neurology and Spine | Phoenix | Arizona | 85032 | United States | ||
| Infinity Clinical Research LLC . |
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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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There were 24 participants screened.
Cohort = C
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| ID | Title | Description |
|---|---|---|
| FG000 | C1: VN - Plan to Start OMB157 | Vaccine naive, planning to start ofatumumab |
| FG001 | C2: VN - on OMB157 >=4 WKs | Vaccine naive, currently on ofatumumab for ≥ 4 weeks |
| 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 | May 26, 2022 | Mar 25, 2024 |
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Participants fully vaccinated with a non-live COVID mRNA vaccine, without or without a booster, and on interferon or glatiramer acetate for at least 4 weeks. |
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| Cohort 6 - Fully vaccinated, currently on OMB457 for ≥ 4 WKs, + booster | Experimental | Participants fully vaccinated with a non-live COVID mRNA vaccine with a booster and on ofatumumab for at least 4 weeks (20 mg subcutaneous) |
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| mRNA COVID-19 vaccine | Biological | Pfizer or Moderna mRNA Vaccine |
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| interferon or glatiramer acetate | Drug | iDMT |
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| Vaccination up to 70, 180, 270 and 360 days |
| Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination. | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Dragonfly Research LLC | Wellesley | Massachusetts | 02481 | United States |
| Minnesota Center Multiple Sclerosis | Plymouth | Minnesota | 55446 | United States |
| The MS Center for Innovation in Care | St Louis | Missouri | 63131 | United States |
| The Neurological Institute PA | Charlotte | North Carolina | 28204 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| FG002 | C3: VN - INFy or GA >=4 WKs | Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks |
| FG003 | C4: FV - OMB157 >=4 WKs | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks |
| FG004 | C5: FV - INFy or GA >=4 WKs | Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks |
| FG005 | C6: FV - on OMB157 >=4 WKs + Booster | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, + booster |
| COMPLETED |
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| NOT COMPLETED |
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There were no participants enrolled in Cohort 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | C1: VN - Plan to Start OMB157 | Vaccine naive, planning to start ofatumumab |
| BG001 | C2: VN - on OMB157 >=4 WKs | Vaccine naive, currently on ofatumumab for ≥ 4 weeks |
| BG002 | C3: VN - INFy or GA >=4 WKs | Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks |
| BG003 | C4: FV - OMB157 >=4 WKs | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks |
| BG004 | C5: FV - INFy or GA >=4 WKs | Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks |
| BG005 | C6: FV - on OMB157 >=4 WKs + Booster | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, + booster |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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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 With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). | Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry. Overall number analyzed included participants who received full course of vaccine (2 doses. n =number of participants with a positive result (responders). M = number of participants in the safety analysis set who received full course (2 doses) of a COVID 19 vaccine, including a COVID-19 booster for Cohort 6 participants | Posted | Number | 95% Confidence Interval | Percentage of participants | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-6: Day 1 |
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| Secondary | Percentage of Patients With an Immune Response by SARS-CoV-2 Qualitative IgG Antibody Assay by Time Point, Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course [2 doses] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders). | Safety analysis set (excluding 2 participants diagnosed with COVID-19 prior to study entry) | Posted | Number | 95% Confidence Interval | Percentage of participants | Vaccination up to 70, 180, 270 and 360 days |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Immune Conversion by Individual Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set) | Immune conversion was defined as (i) pre-vaccination absence of SARS-CoV-2 qualitative IgG antibody with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 1-3 only); or (ii) pre vaccination presence of SARS-CoV-2 quantitative IgG antibody (i.e., pre vaccination value ≥0.80 U/mL) with any post-vaccination ≥4-fold increase in SARS-CoV-2 quantitative IgG antibody titer (Cohorts 1-3 only); or (iii) initial negative SARS-CoV-2 nucleocapsid antibody assay with any post-vaccination positive SARS-CoV-2 qualitative IgG antibody assay (Cohorts 4 and 5 only). There was no baseline for Cohort 6 because there was no blood collection prior to vaccination. | Safety analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Cohorts 1 - 3: >=14 days after vaccination: Day 36 (Pfizer) or Day 43 (Moderna); Cohorts 4-5: Day 1 |
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Adverse events and serious adverse events were presented from first day of screening , treatment and 30 day safety follow up to a maximum duration of 421 days.
Cohorts 2 and 4 have been combined as participants were on ofatumumab >4 weeks and Cohort 3 and 5 were combined because both cohorts were on glatiramer acetate or IFN for >4 weeks. Purpose of the trial was to determine if ofatumumab affected immune response.
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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 1 | C1: VN - plan to start OMB157 Vaccine naive, planning to start ofatumumab | 0 | 5 | 0 | 5 | 5 | 5 |
| EG001 | Cohort 2 | C2: VN - on OMB157 >=4 WKs Vaccine naive, currently on ofatumumab for ≥ 4 weeks | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Cohort 3 | C3: VN - INFy or GA >=4 WKs Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort 4 | C4: FV - OMB157 >=4 WKs Fully vaccinated, currently on ofatumumab for ≥ 4 weeks | 0 | 1 | 0 | 1 | 0 | 1 |
| EG004 | Cohort 5 | C5: FV - INFy or GA >=4 WKs Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks | 0 | 11 | 1 | 11 | 2 | 11 |
| EG005 | Cohort 6 | C6: FV - on OMB157 >=4 WKs + booster Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, + booster | 0 | 5 | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA (26.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (26.0) | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (26.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (26.0) | Systematic Assessment |
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| Influenza A virus test positive | Investigations | MedDRA (26.0) | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA (26.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Muscle discomfort | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
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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 | Jun 28, 2023 | Mar 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| 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 |
| C000722934 | CVnCoV COVID-19 vaccine |
| D007372 | Interferons |
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black or African American |
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| Missing |
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| C4: FV - OMB157 >=4 WKs |
Fully vaccinated, currently on ofatumumab for ≥ 4 weeks |
| OG004 | C5: FV - INFy or GA >=4 WKs | Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks |
| OG005 | C6: FV - on OMB157 >=4 WKs + Booster | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks, + booster |
| OG006 | Overall | All cohorts |
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Vaccine naive, on interferon or glatiramer acetate for ≥ 4 weeks
| OG003 | C4: FV - OMB157 >=4 WKs | Fully vaccinated, currently on ofatumumab for ≥ 4 weeks |
| OG004 | C5: FV - INFy or GA >=4 WKs | Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 weeks |
| OG005 | Overall | Includes all cohorts |
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