Clinical Trials List
Protocol NumberCOMB157G2399
NCT Number(ClinicalTrials.gov Identfier)NCT03650114
Active
2019-03-28 - 2029-04-06
Phase III
Terminated1
ICD-10G35
Multiple sclerosis
ICD-9340
Multiple sclerosis
An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis (RMS)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Han-Wei Huang Division of Neurology
- 謝函潔 Division of Neurology
- 林典佑 Division of Neurology
- Thy-Sheng Lin Division of Neurology
- Yuan-Ting Sun Division of Neurology
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Condition/Disease
Relapsing Multiple Sclerosis
Objectives
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).
Test Drug
OMB157
Active Ingredient
OMB157(Ofatumumab)
Dosage Form
Injection
Dosage
20mg/0.4ml
Endpoints
Primary Outcome Measures:
1. Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes.
Secondary Outcome Measures:
1. Number of relapse rates per year.
2. Patients with confirmed 3 and 6 month disability worsening.
3. Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study.
4. Patients with changes in Expanded Disability Status Scale (EDSS) scores .
5. Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores.
6. Changes in the Magnetic Resonance Image (MRI) related to brain volume loss.
7. Changes in the Magnetic Resonance Image (MRI) related to T2 lesions .
8. Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions.
9. Changes in neurofilament light change serum concentration.
Other Outcome Measures:
1. Hummoral immune response to TT vaccine.
2. Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV).
3. Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV).
4. Humoral immune response to KLH neo-antigen.
5. Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine.
6. Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab.
1. Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes.
Secondary Outcome Measures:
1. Number of relapse rates per year.
2. Patients with confirmed 3 and 6 month disability worsening.
3. Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study.
4. Patients with changes in Expanded Disability Status Scale (EDSS) scores .
5. Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores.
6. Changes in the Magnetic Resonance Image (MRI) related to brain volume loss.
7. Changes in the Magnetic Resonance Image (MRI) related to T2 lesions .
8. Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions.
9. Changes in neurofilament light change serum concentration.
Other Outcome Measures:
1. Hummoral immune response to TT vaccine.
2. Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV).
3. Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV).
4. Humoral immune response to KLH neo-antigen.
5. Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine.
6. Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab.
Inclution Criteria
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks.
2. Written informed consent.
Vaccination sub-study:
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.
2. Written informed consent.
Vaccination sub-study:
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
1. Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject.
2. Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS).
3. Subjects taking medications prohibited by the protocol.
4. Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Vaccination sub-study:
1. known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines.
2. allergies to egg or shellfish.
3. any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start.
4. any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit.
2. Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS).
3. Subjects taking medications prohibited by the protocol.
4. Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.
Vaccination sub-study:
1. known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines.
2. allergies to egg or shellfish.
3. any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start.
4. any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit.
The Estimated Number of Participants
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Taiwan
2 participants
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Global
2000 participants
