Status:
COMPLETED
Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries
Detailed Description
This study had 2 parts: A controlled Core and an open-label Extension. * Core part: A 24-week, randomized, double-blind, placebo controlled, parallel-group, multicenter study evaluated the efficacy, ...
Eligibility Criteria
Inclusion
- Diagnosis of multiple sclerosis (MS)
- Relapsing MS (RMS)
- At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhancing T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization
- EDSS score of 0 to 5.5
Exclusion
- Primary progressive MS or SPMS without disease activity
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03249714
Start Date
March 15 2018
End Date
July 29 2020
Last Update
April 29 2022
Active Locations (14)
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1
Novartis Investigative Site
Tōon, Ehime, Japan, 791-0295
2
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 812-8582
3
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 063-0005
4
Novartis Investigative Site
Morioka, Iwate, Japan, 020-8505