A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis

Phase 3

Completed

• Conditions: MS; Multiple Sclerosis; 10029305

• Registration Number: NL-OMON47697
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Male or female patients aged 18 to 55 years (inclusive) at Screening
* 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
* 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
* Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing
* Sexually active males unless they agree to use condom during intercourse while on study drug
* 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 at risk of developing or having reactivation of syphilis or tuberculosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Annual Relapse Rate (ARR)<br /><br>* Time to disability worsening as measured by 3-month confirmed worsening<br /><br>(3mCDW) on Expanded Disability Status Scale (EDSS)<br /><br>* Time to disability worsening as measured by 6-month confirmed worsening<br /><br>(6mCDW) on EDSS<br /><br>* Time to disability improvement as measured by 6-month confirmed improvement<br /><br>(6mCDI) on EDSS<br /><br>* Number of T1 gadolinium (Gd)-enhancing lesions per Magnetic Resonance Image<br /><br>(MRI) scan<br /><br>* Number of new or enlarging T2 lesions on MRI per year (annualized T2 lesion<br /><br>rate)<br /><br>* Neurofilament light chain (NfL) concentration in serum<br /><br>* Rate of brain volume loss (BVL) based on assessments of percentage brain<br /><br>volume change from baseline</p><br>