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| Column | Value |
|---|---|
| Trial registration number | NCT04878211 |
|
Full text link
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
novartis.email@novartis.com |
|
Registration date
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-05-07 |
|
Recruitment status
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
nonRCT |
|
Allocation
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Aug. 12, 2021, 4 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - signed informed consent must be obtained prior to participation in the study - diagnosis of relapsing ms by 2017 revised mcdonald criteria - willing to comply with the study schedule - will be receiving an mrna covid-19 vaccine (pfizer or moderna vaccine) at least two weeks prior to starting ofatumumab - eligible to receive and plan to be started on ofatumumab or currently on prescribed ofatumumab for ≥ 4 weeks or currently on commercially prescribed interferon or glatiramer acetate for ≥ 4 weeks |
|
Exclusion criteria
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- already has received pfizer, moderna or johnson & johnson vaccine - known diagnosis of covid-19 prior to screening - has a contraindication to receiving an mrna covid-19 vaccine - has an immediate allergic reaction to past vaccine or injection - any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit |
|
Number of arms
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
8 |
|
Funding
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Novartis Pharmaceuticals |
|
Inclusion age min
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
55 |
|
Countries
Last imported at : July 16, 2021, 6 a.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
High risk patients |
|
Severity scale
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : April 19, 2023, noon Source : ClinicalTrials.gov |
88 |
|
primary outcome
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Percentage of patients achieving a SARS-CoV-2 immune response |
|
Notes
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 4 |
|
Arms
Last imported at : May 9, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)", "treatment_id": 2294, "treatment_name": "Bnt162b2+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least two weeks prior to start of ofatumumab (20 mg subcutaneous)", "treatment_id": 2293, "treatment_name": "Mrna-1273+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least 4 weeks prior to start of ofatumumab (20 mg subcutaneous)", "treatment_id": 2294, "treatment_name": "Bnt162b2+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least 4 weeks prior to start of ofatumumab (20 mg subcutaneous)", "treatment_id": 2293, "treatment_name": "Mrna-1273+ofatumumab", "treatment_type": "Rna based vaccine+monoclonal antibodies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least 4 weeks after start of prescribed interferon", "treatment_id": 2215, "treatment_name": "Bnt162b2+interferon", "treatment_type": "Rna based vaccine+interferons", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least 4 weeks after start of prescribed interferon", "treatment_id": 2216, "treatment_name": "Interferon+mrna-1273", "treatment_type": "Interferons+rna based vaccine", "pharmacological_treatment": "Pharmacological treatment+vaccine"}, {"arm_notes": "vaccine at least 4 weeks after start of prescribed glatiramer acetate", "treatment_id": 2296, "treatment_name": "Bnt162b2+glatiramer", "treatment_type": "Rna based vaccine+other targeted therapies", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "vaccine at least 4 weeks after start of prescribed glatiramer acetate", "treatment_id": 2297, "treatment_name": "Glatiramer+mrna-1273", "treatment_type": "Other targeted therapies+rna based vaccine", "pharmacological_treatment": "Pharmacological treatment+vaccine"}] |