CompletedPhase 3

Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

France185 participantsStarted 2021-07-23

Plain-language summary

This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Written informed consent obtained before any assessment
✓. Male/female patients, 18 through 55 (inclusive) years of age.
✓. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018).
✓. Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.
✓. Treatment Naïve patients, ≤ 5 years since first MS symptom.
✓. EDSS score 0-4.0 (inclusive).
✓. Patient must be suitable to be treated with one of first line self-administered DMT-physician's choice (glatiramer acetate, IFNs, teriflunomide, DMF, diroximel fumarate according to EMA SmPC) or ofatumumab depending on randomization and physician's choice
✓. At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening.

Exclusion criteria

✕. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
✕. Progressive MS phenotypes: Patients with primary progressive MS (Polman et al 2011) or SPMS (Lublin et al 2014).
✕. Use of other experimental or investigational drugs at the time of enrollment (Screening) or within the prior 30 days, or 5 elimination half-lives, or until the expected pharmacodynamics effect has returned to baseline, whichever is longer
✕. Relapse between Screening and Baseline visits
✕. Pregnancy or breastfeeding
✕. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
✕. Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (methods that result in less than 1% pregnancy rates) while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC.
✕. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency)

What they're measuring

Number of participants with no evidence of disease activity (NEDA-3)

Timeframe: Baseline to 15 month

Trial details

NCT IDNCT04788615

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-04

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