Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

Conditions

• Relapsing Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Ofatumumab subcutaneous injection — DRUG
  Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
• Teriflunomide-matching placebo capsules — DRUG
  Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
• Teriflunomide capsule — DRUG
  Teriflunomide 14 mg oral capsule taken once daily
• Matching placebo of ofatumumab subcutaneous injections — DRUG
  Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter

Study Details

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

Key Dates

Start date

Sep 20, 2016

Status verified

Sep 2021

Primary completion

Jul 5, 2019

Completion

Jul 20, 2020

Study Design

Enrollment

930 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: OMB 20 mg
  Ofatumumab 20 mg pre-filled syringes for subcutaneous injectionon on days 1 ,7 ,14, week 4 and every 4 weeks thereafter and a teriflunomide- matching placebo, taken orally once daily
• Active Comparator: TER 14 mg
  Teriflunomide 14 mg oral capsule taken once daily and matching placebo for subcutaneous injections to ofatumumab on days 1, 7, 14, week 4 and every 4 weeks thereafter

Primary Outcome Measure

Annualized Relapse Rate (ARR) [ Time Frame: Baseline up to 2.5 years ]

Locations (56)

Find similar trials in Phoenix, AZ

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