Clinical Trials List
Protocol NumberCOMB157G2302
2016-10-20 - 2019-11-30
Phase III
Terminated1
Study ended1
ICD-10G35
Multiple sclerosis
ICD-9340
Multiple sclerosis
A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chou-Ching Lin Division of Neurology
- Yuan-Ting Sun Division of Neurology
- 謝函潔 Division of Neurology
- Han-Wei Huang Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- Yu-Wan Yang Division of Neurology
- Kang-Hsu Lin Division of Neurology
Condition/Disease
relapsing multiple sclerosis
Objectives
To demonstrate that ofatumumab is superior to teriflunomide in reducing
the frequency of confirmed relapses as evaluated by the annualized
relapse rate (ARR) in patients with relapsing MS
Test Drug
Ofatumumab
Active Ingredient
Ofatumumab
Dosage Form
vial
Dosage
50
Endpoints
Primary:
To demonstrate that ofatumumab is superior to teriflunomide in reducing
the frequency of confirmed relapses as evaluated by the annualized
relapse rate (ARR) in patients with relapsing MS
Secondary:
To evaluate if ofatumumab is superior to teriflunomide on:
Time to disability worsening as measured by 3-month confirmed
worsening (3mCDW) on Expanded Disability Status Scale (EDSS)
Time to disability worsening as measured by 6-month confirmed
worsening (6mCDW) on EDSS
Time to disability improvement as measured by 6-month confirmed
improvement (6mCDI) on EDSS
Number of T1 gadolinium (Gd)-enhancing lesions per Magnetic
Resonance Image (MRI) scan
Number of new or enlarging T2 lesions on MRI per year (annualized T2
lesion rate)
Rate of brain volume loss (BVL) based on assessments of percentage
brain volume change from baseline
To demonstrate that ofatumumab is superior to teriflunomide in reducing
the frequency of confirmed relapses as evaluated by the annualized
relapse rate (ARR) in patients with relapsing MS
Secondary:
To evaluate if ofatumumab is superior to teriflunomide on:
Time to disability worsening as measured by 3-month confirmed
worsening (3mCDW) on Expanded Disability Status Scale (EDSS)
Time to disability worsening as measured by 6-month confirmed
worsening (6mCDW) on EDSS
Time to disability improvement as measured by 6-month confirmed
improvement (6mCDI) on EDSS
Number of T1 gadolinium (Gd)-enhancing lesions per Magnetic
Resonance Image (MRI) scan
Number of new or enlarging T2 lesions on MRI per year (annualized T2
lesion rate)
Rate of brain volume loss (BVL) based on assessments of percentage
brain volume change from baseline
Inclution Criteria
Male or female patients aged 18 to 55 years (inclusive) at Screening
Diagnosis of MS according to the 2010 Revised McDonald criteria
Relapsing MS: relapsing-remitting course (RRMS), or secondary
progressive (SPMS) course with disease activity
Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
Documentation of at least: 1 relapse during the previous 1 year OR 2
relapses during the previous 2 years prior to Screening OR a positive
Gd-enhancing MRI scan during the year prior to randomization (Note:
Screening MRI scan may be used if no positive Gd-enhancing scan
exist from prior year).
Neurologically stable within 1 month prior to randomization
Diagnosis of MS according to the 2010 Revised McDonald criteria
Relapsing MS: relapsing-remitting course (RRMS), or secondary
progressive (SPMS) course with disease activity
Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive)
Documentation of at least: 1 relapse during the previous 1 year OR 2
relapses during the previous 2 years prior to Screening OR a positive
Gd-enhancing MRI scan during the year prior to randomization (Note:
Screening MRI scan may be used if no positive Gd-enhancing scan
exist from prior year).
Neurologically stable within 1 month prior to randomization
Exclusion Criteria
Patients with primary progressive MS or SPMS without disease activity
Patients meeting criteria for neuromyelitis optica
Disease duration of more than 10 years in patients with an EDSS score
of 2 or less
Pregnant or nursing (lactating) women
Women of child-bearing potential unless using highly effective methods
of contraception during study drug dosing and for 12 months postdosing
Sexually active males unless they agree to use condom during
intercourse while on study drug
Patients with an active chronic disease of the immune system other
than MS
Patients with neurological findings consistent with PML or confirmed
PML
Patients at risk of developing or having reactivation of hepatitis:
positive results at Screening for serology markers for hepatitis A, B, C
and E (HA, HB, HC, and HE) indicating acute or chronic infection
Patients with active systemic infections or known to have AIDS or to
test positive for HIV antibody at Screening
Patients at risk of developing or having reactivation of syphilis or
tuberculosis
Have received any live or live-attenuated vaccines within 2 months
prior to randomization
Have been treated with medications as specified or within timeframes
specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, cyclophosphamide, teriflunomide,
leflunomide, etc.)
Any other disease or condition that could interfere with participation in
the study according to the study protocol, or with the ability of the
patients to cooperate and comply with the study procedures.
Patients meeting criteria for neuromyelitis optica
Disease duration of more than 10 years in patients with an EDSS score
of 2 or less
Pregnant or nursing (lactating) women
Women of child-bearing potential unless using highly effective methods
of contraception during study drug dosing and for 12 months postdosing
Sexually active males unless they agree to use condom during
intercourse while on study drug
Patients with an active chronic disease of the immune system other
than MS
Patients with neurological findings consistent with PML or confirmed
PML
Patients at risk of developing or having reactivation of hepatitis:
positive results at Screening for serology markers for hepatitis A, B, C
and E (HA, HB, HC, and HE) indicating acute or chronic infection
Patients with active systemic infections or known to have AIDS or to
test positive for HIV antibody at Screening
Patients at risk of developing or having reactivation of syphilis or
tuberculosis
Have received any live or live-attenuated vaccines within 2 months
prior to randomization
Have been treated with medications as specified or within timeframes
specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, cyclophosphamide, teriflunomide,
leflunomide, etc.)
Any other disease or condition that could interfere with participation in
the study according to the study protocol, or with the ability of the
patients to cooperate and comply with the study procedures.
The Estimated Number of Participants
-
Taiwan
12 participants
-
Global
900 participants
