Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Status:
Active, not recruiting
Sponsors
Novartis Pharmaceuticals
Abstract:
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
Description:
This is a randomized, double-blind, double-dummy, active comparator-controlled, parallel-group, multicenter study with variable treatment duration in approximately 900 patients with relapsing MS. The maximal treatment duration in the study for an individual patient will be 2.5 years.
Eligible patients will be randomized to receive either experimental ofatumumab subcutaneous (sc) injections every 4 weeks or active comparator teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).
Condition or disease:Relapsing Multiple Scelrosis
Intervention/treatment:
Drug: Ofatumumab
Drug: Ofatumumab
Drug: Teriflunomide
Drug: Teriflunomide
Phase:Phase 3
Study design:
Study Type:Interventional
Allocation:Randomized
Primary Purpose:Treatment
Masking:Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm group:
ArmIntervention/treatment
Experimental: Ofatumumab
Syringes for subcutaneous injection Patients will also take a placebo capsule (matching in appearance to teriflunomide)
Drug: Ofatumumab
Patients randomized to the ofatumumab arm will receive subcutaneous injections of ofatumumab every 4 weeks
Active Comparator: Teriflunomide
Oral capsule Patients will also take subcutaneous injections of placebo (syringes matching in appearance to ofatumumab)
Drug: Teriflunomide
Patients randomized to the teriflunomide arm will take teriflunomide orally once daily
Eligibility Criteria:
Ages Eligible for Study:18 Years to 18 Years
Sexes Eligible for Study:All
Accepts Healthy Volunteers:Yes
Criteria:

Inclusion Criteria:

- Diagnosis of multiple sclerosis (MS)

- Relapsing MS (RRMS or SPMS) course

- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan in previous year

- EDSS score of 0 to 5.5

Exclusion Criteria:

- Primary progressive MS

- 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

Other protocol-defined inclusion/exclusion criteria may apply

Outcome:
Primary Outcome Measures
1. Annualized relapse rate (ARR) [up to 2.5 years]
ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
Secondary Outcome Measures
1. Time to 3-month confirmed disability worsening on EDSS [Baseline, every 3 months up to 2.5 years]
A 3-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3 months.
2. Time to 6-month confirmed disability worsening on EDSS [Baseline, every 3 months up to 2.5 years]
A 6-month confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 6 months.
3. Time to 6-month confirmed disability improvement on EDSS [Baseline, every 3 months up to 2.5 years]
A 6-month confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6 months.
4. Number of gadolinium (Gd)-enhancing lesions per MRI scan [Baseline, yearly up to 2.5 years]
Total number of Gd-enhancing lesions across all scans per patient adjusted for different number of scans due to variable follow up time in study
5. Number of new or enlarging T2 lesions on MRI per year (annualized lesion rate) [Baseline, yearly up to 2.5 years]
Number of new/enlarging T2 lesions on last available MRI scan compared to baseline adjusted for different time of scans versus baseline due to variable follow up time in study
6. Neurofilament light chain (Nfl) concentration in serum [Baseline, every 3 months up to 2.5 years]
The NfL concentration (geometric mean concentration) will be estimated by treatment and time point with using a repeated measures model on the basis of all evaluable log-transformed NfL values.
7. Rate of brain volume loss based on assessments of percentage brain volume change from baseline [Baseline, yearly up to 2.5 years]
Percent change from baseline in brain volume loss (BVL) on all MRI scans adjusted for different time of scan versus baseline due to variable follow up time in study
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