relapsing multiple sclerosis MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Kesimpta
Product Name: Kesimpta 20 mg Injektionslösung im Fertigpen
Product Code: OMB157G
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS
Sponsors
Novartis Pharma Vertriebs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Patients eligible to start ofatumumab as per physician’s discretion and approved SmPC (exp. April, 2021; for cohort 2, patients may already be on ofatumumab, but most patients will start ofatumumab as part of this study). 3. Patients willing and eligible to receive a modRNA vaccine against SARS-CoV-2 as part of clinical routine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of COVID-19 or current COVID-19 symptoms 2. Patients who previously received a BTK inhibitor or an antiCD20 therapy other than ofatumumab 3. Patients likely not being able or willing to complete the study 4. Use of other investigational drugs within 5 half-lives of enrollment/initiation of study treatment (e.g. small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer 5. Patients with any medical or psychological condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study 6. No person directly associated with the administration of the study is allowed to participate as a study subject 7. No family member of the investigational study staff is allowed to participate in this study 8. No previous vaccination with a non-modRNA SARS-CoV-2 vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the proportion of RMS patients having established SARS-CoV-2-specific T cells after receiving a modRNA vaccine (initial vaccination cycle or booster vaccine) either before or after starting ofatumumab treatment.;Secondary Objective: To estimate: • the proportion of RMS patients maintaining for up to 18 months SARS-CoV-2-specific T cells after receiving a modRNA vaccine either before or after starting ofatumumab treatment • the proportion of RMS patients achieving seroconversion (i.e. having SARS-CoV-2 serum neutralizing antibodies) after receiving a modRNA vaccine either before or after starting ofatumumab treatment • the proportion of RMS patients maintaining for up to 18 months quantifiable levels of SARS-CoV-2 serum functional antibodies after receiving a modRNA vaccine either before or after starting ofatumumab treatment • the proportion of RMS patients with quantifiable SARS-CoV-2-specific T cells and functional antibodies after receiving an additional dose of modRNA vaccine (booster vaccine) Describing: • phenotypically the cellular response after receiving a modRNA vaccine either before or after starting ofatumumab treatment • safety and tolerability, incl. patients developing coronavirus disease 2019;Primary end point(s): Proportion of RMS patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. enzyme-linked immunosorbent spot (ELIspot) assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either one month after second dose of vaccine or one month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment (yes/no);Timepoint(s) of evaluation of this end point: either one month after second dose of vaccine or one month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of RMS patients with detectable SARS-CoV-2 reactive T-cells one week, 6, 12 and 18 months 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 (yes/no) • Fold change of SARS-CoV-2 specific T-cell levels one week, 1 month, 6 months, 12 months and 18 months after the second dose of vaccine or 1 months, 6 months and 18 months after a booster vaccine compared to the last timepoint before the respective vaccine • Proportion of RMS patients achieving seroconversion (i.e. having SARS-CoV-2 serum neutralizing antibodies) after receiving a modRNA vaccine either before or after starting ofatumumab treatment (yes/no) • Proportion of RMS patients with quantifiable levels of SARS-CoV-2 serum functional antibodies one week, 1, 6, 12 and 18 months after receiving the second dose of modRNA vaccine or 1, 6 and 12 months after a booster shot either before or after starting ofatumumab treatment (yes/no) • Phenotypical characterization of peripheral blood mononuclear cells for CD45, CD3, CD4, CD8, CD62l, CD45RA, CD45R0, CCR7 • Immunophenotyping for naive, central memory, effector memory, and effector cells on CD4+ and CD8+ cells • Measuring cells positive for intracellular cytokine-staining for interferon-gamma and interleukin-4 • AEs, SAEs, incl. patients with clinical confirmed COVID-19;Timepoint(s) of evaluation of this end point: • Proportion of RMS patients with detectable SARS-CoV-2 reactive T-cells one week, 6, 12 and 18 months 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 • Fold change of SARS-CoV-2 specific T-cell levels one week, 1 month, 6 months, 12 months and 18 months after the second dose of vaccine or 1 months, 6 months and 18 months after a booster vaccine compared to the last timepoint before the respective vaccine • Pro | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed