Phase 3
Completed N=955
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Relapsing Multiple Scelrosis
Source: ClinicalTrials.gov NCT02792231 ↗
Enrolled (actual)
955
Serious AEs
8.3%
Results posted
Oct 2020
Primary outcomePrimary: Annualized Relapse Rate (ARR) — 0.10; 0.25 number of relapses in a year — p=<0.001
◆ Published Evidence
Highly cited
694citations · ~116 / year
Ofatumumab versus Teriflunomide in Multiple Sclerosis.
Summary
To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis
Linked Publications (4)
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Ofatumumab versus Teriflunomide in Multiple Sclerosis.
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Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II.
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Efficacy of Ofatumumab and Teriflunomide in Patients With Relapsing MS From Racial/Ethnic Minority Groups: ASCLEPIOS I/II Subgroup Analyses.
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Cost-consequence analysis of ofatumumab for the treatment of relapsing-remitting multiple sclerosis in Canada.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) |
0.10; 0.25 | <0.001 sig |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Pooled Data |
9.4; 13.5; 10.9; 15.0 | 0.003 sig |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS - Study COMB157G2302 |
9.3; 13.2; 10.5; 14.6 | 0.038 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Pooled Data |
7.8; 10.7; 8.1; 12.0 | 0.012 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS - Study COMB157G2302 |
8.0; 10.0; 8.0; 10.9 | 0.215 |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Pooled Data |
10.1; 7.6; 11.0; 8.2 | 0.092 |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI ) Based on EDSS - Study COMB157G2302 |
11.1; 8.1; 12.3; 8.1 | 0.090 |
| SECONDARY Number of Gadolinium-enhancing T1 Lesions Per MRI Scan |
0.0317; 0.5172 | <.001 sig |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate) |
0.94; 4.41; 0.72; 3.72; 0.64; 4.16 | <.001 sig |
| SECONDARY Neurofilament Light Chain (NfL) Concentration in Serum |
8.92; 10.02; 7.06; 9.53; 6.80; 8.99 | <.001 sig |
| SECONDARY Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline |
-0.29; -0.35 | 0.128 |
| SECONDARY Participants With Confirmed Relapse |
16.51; 32.68 | — |
| SECONDARY Annualized Relapse Rate (ARR) >8 Weeks After Onset of Treatment |
0.096; 0.241 | — |
| SECONDARY 3-month Confirmed Disability Worsening (3mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data |
9.4; 13.5; 10.9; 15.0 | 0.002 sig |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) Based on EDSS > 8 Weeks After Onset of Treatment - Pooled Data |
7.8; 10.7; 8.1; 12.0 | 0.008 sig |
| SECONDARY 6-month Confirmed Cognitive Decline on Symbol Digit Modalities Test (SDMT) - Pooled Data |
14.3; 13.7; 15.4; 14.0 | — |
| SECONDARY 6-month Confirmed Disability Worsening (6mCDW) or 6-month Confirmed Cognitive Decline (6mCCD) - Pooled Data |
20.5; 21.7; 21.4; 22.6 | — |
| SECONDARY Change in Cognitive Performance Measured by the Symbol Digit Modalities Test (SDMT) - Pooled Data |
1.02; 0.64; 1.82; 1.70; 2.84; 2.05 | — |
| SECONDARY 6-month Confirmed Worsening of at Least 20% in the Timed 25-Foot Walk (T25FW) - Pooled Data |
11.0; 10.4; 11.4; 10.6 | — |
| SECONDARY 6-month Confirmed Worsening of at Least 20% in the 9-Hole Peg Test (9HPT) - Pooled Data |
2.9; 3.3; 2.9; 3.3 | — |
| SECONDARY 6-month Confirmed Disability Improvement (6mCDI) Sustained Until End of Study (EOS) as Measured by EDSS - Pooled Data |
5.4; 4.6; 5.8; 4.6 | — |
| SECONDARY Number of New or Enlarging T2 Lesions on MRI Per Year From Month 12 Until End of Study (EOS) |
0.13; 3.84 | — |
| SECONDARY Percent Change in T2 Lesion Volume Relative to Baseline |
-2.4; 10.1; -2.6; 17.8 | — |
| SECONDARY No Evidence of Disease Activity (NEDA-4) |
23.8; 17.8; 9.8; 5.1 | — |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score Change From Baseline |
-2.20; -0.46; -2.47; -0.49; -2.29; 1.53 | — |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) Psychological Impact Score Change From Baseline |
-5.96; -3.77; -5.42; -3.88; -6.23; -2.51 | — |
| SECONDARY Annualized Relapse Rates (ARR) by NfL High-low Subgroups - Pooled Data |
0.08; 0.21; 0.12; 0.23 | — |
| SECONDARY Number of New or Enlarging T2 Lesions Per Year by NfL High-low Subgroups - Pooled Data |
0.95; 5.28; 0.39; 3.02 | — |
| SECONDARY Brain Volume Loss by NfL High-low Subgroups - Pooled Data |
-0.32; -0.43; -0.24; -0.29 | — |
| SECONDARY Pharmacokinetic (PK) Concentrations of Ofatumumab |
0.00325; 1.26512; 0.20932; 0.38203; 0.59087; 1.13218 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged 18 to 55 years at Screening
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
- Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
- Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
- Neurologically stable within 1 month prior to randomization
Exclusion Criteria
- Patients with primary progressive MS or SPMS without disease activity
- Disease duration of more than 10 years in patients with an EDSS score of 2 or less
- Patients with an active chronic disease of the immune system other than MS
- Patients at risk of developing or having reactivation of hepatitis
- Patients with active systemic infections or with neurological findings consistent with PML
Data sourced from ClinicalTrials.gov (NCT02792231) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.