Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab i

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Running, not recruitingPhase 3Relapsing MSNCT036501142023-507906-15-002017-004703-51

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ofatumumab

    B-lymphocyte antigen CD20 binding agent

  • Tetanus toxoid (TT) containing vaccine (Td, Tdap)
  • 13-valent pneumococcal conjugate vaccine (13-PCV)
  • 23-valent pneumococcal polysaccharide vaccine (23-PPV)
  • Seasonal Quadrivalent influenza vaccine
  • Keyhole limpet hemocyanin (KLH) neo-antigen
  • PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
  • Aluminum phosphate
  • PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1, PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A
  • B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE), B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021), A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE), A/WISCONSIN/67/2022 (H1N1)PDM09-LIKE STRAIN (A/GEORGIA/12/2022 CVR-167)

What it measured

Main measures

  • Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes

    Up to 8 years

    Safety

  • • Proportion of subjects with adverse events

    Safety

  • Proportion of subjects with laboratory, or vital signs results meeting abnormal criteria

    Safety

  • Proportion of subjects with electrocardiogram (ECG) meeting abnormal criteria [through Week 240 (EOS)]

  • Proportion of subjects meeting predefined criteria in Columbia Suicide Severity Rating Scale (C SSRS) [through Week 240/EOS]

Other measures (27)

  • Number of relapse rates per year

    Data from the core studies through the first 5 years in this study.

    Relapses

  • Patients with confirmed 3 and 6 month disability worsening

    During the first 5 years of treatment in the study.

    Disability progressionFatigueBladder, bowel and sexual function

  • Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.

    During the first 5 years of treatment in the study.

    Disability progressionFatigueBladder, bowel and sexual function

  • Patients with changes in Expanded Disability Status Scale (EDSS) scores

    Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization)

    Disability progressionFatigueBladder, bowel and sexual function

  • Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores

    During the first 5 years of the study.

    Thinking and memory

  • Changes in the Magnetic Resonance Image (MRI) related to brain volume loss

    Data from the core studies through the first 5 years in this study.

    MRI lesionsBrain volume loss

  • Changes in the Magnetic Resonance Image (MRI) related to T2 lesions

    Data from the core studies through the first 5 years in this study.

    MRI lesions

  • Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions

    Data from the core studies through the first 5 years in this study.

    MRI lesions

  • Changes in neurofilament light change serum concentration

    Data from the core studies through the first 5 years in this study.

    Blood or spinal fluid markersHow the body handles the medicine

  • • Annualized Relapse Rate (ARR)

    Relapses

Who could take part

Relapsing MS · 18 to 100

Show the full criteria

Inclusion criteria

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks 2. Written informed consent

Exclusion criteria

* Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject * Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS) * Subjects taking medications prohibited by the protocol * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply Vaccination sub-study: Inclusion criteria 1. Informed consent 2. Actively enrolled in the COMB157G2399 Study 3. 12 weeks of continuous treatment within the COMB157G2399 Study 4. prior vaccination history as per protocol-defined Exclusion criteria * known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines * allergies to egg or shellfish * any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start * any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit Other protocol-defined inclusion/exclusion criteria may apply

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Papers

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History

    1. Started

      Dec 2018

    2. Main results due

      Sept 2028

    3. Finished

      Sept 2028

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