Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005418-31-BE

Enrollment

900

Registered

2016-07-07

Start date

2016-10-17

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis MedDRA version: 19.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: OFATUMUMAB CAS Number: 679818-59-8 Current Spon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Male or female patients aged 18 to 55 years (inclusive) at screening •Diagnosis of MS according to the 2010 Revised McDonald criteria •Relapsing form of MS: relapsing-remitting course (RRMS), or secondary progressive course with disease activity (relapsing SPMS) •Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive) •At least 1 documented relapse during the previous 1 year OR at least 2 documented relapses during the previous 2 years OR a positive GdE MRI scan during the year prior to randomization and including screening. •Neurologically stable within 1 month prior to randomization Please see protocol for complete detailed list of inclusion criteria 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 900 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Patients with primary progressive MS or SPMS without disease activity •Disease duration of more than 10 years in patients with EDSS score of 2 or less •Pregnant or nursing (lactating) women •women of child bearing potential not using highly effective contraception •Patients with an active chronic disease •Patients with active systemic infections, or history of or known presence of recurrent or chronic infection •Have received any live or live-attenuated vaccines within 2 months prior to randomization •Have been treated with medications as specified within the timeframes specified (e.g. ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, teriflunomide, etc) •Any other disease or condition which 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. Please see protocol for complete detailed list of exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.;Secondary Objective: Key secondary objectives To evaluate if ofatumumab is superior to teriflunomide on: 1. Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on EDSS 2. Number of T1 GdE lesions per MRI scan 3. Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate) 4. Time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on EDSS 5. Rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline 6. Time to disability improvement, as measured by 6-month confirmed improvement (6mCDI) on EDSS See protocol for complete list of secondary objectives.;Primary end point(s): Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.;Timepoint(s) of evaluation of this end point: Up to 30 months	—

Measure

Time frame

Main Objective: Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.;Secondary Objective: Key secondary objectives To evaluate if ofatumumab is superior to teriflunomide on: 1. Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on EDSS 2. Number of T1 GdE lesions per MRI scan 3. Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion rate) 4. Time to disability worsening as measured by 6-month confirmed worsening (6mCDW) on EDSS 5. Rate of brain volume loss (BVL) based on assessments of percentage brain volume change from baseline 6. Time to disability improvement, as measured by 6-month confirmed improvement (6mCDI) on EDSS See protocol for complete list of secondary objectives.;Primary end point(s): Demonstrate that ofatumumab 20 mg sc once every 4 (q4) weeks is superior to teriflunomide 14 mg po once daily in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS.;Timepoint(s) of evaluation of this end point: Up to 30 months

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Secondary

Measure	Time frame
Secondary end point(s): -Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on The 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 Gd-enhancing lesions per 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.;Timepoint(s) of evaluation of this end point: Up to 30 months	—

Measure

Time frame

Secondary end point(s): -Time to disability worsening as measured by 3-month confirmed worsening (3mCDW) on The 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 Gd-enhancing lesions per 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.;Timepoint(s) of evaluation of this end point: Up to 30 months

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Countries

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Korea, Republic of, Kuwait, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026