An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy

ClinicalTrials.gov Identifier: NCT04353492

Novartis Reference Number: COMB157G23101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The open label study to evaluate effectiveness of treatment with ofatumumab in patients transitioning from commonly used oral MS therapies - fingolimod or dimethyl fumarate, due to breakthrough disease.

Condition 
Relapsing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
550 participants
Start date 
Jul 14, 2020
Completion date 
Jun 21, 2024
Gender 
All
Age(s)
18 Years - 60 Years (Adult)

Interventions

Biological
Ofatumumab
Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)

Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple sclerosis (MS)
Relapsing MS (RRMS or SPMS) course
Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug
Breakthrough disease as evidence by clinical relapses or MRI
EDSS score of 0 to 4

Exclusion Criteria:

Primary progressive MS or SPMS without disease activity
Disease duration of more than 10 years since diagnosis
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

Study Locations

United States
Novartis Investigative Site
Recruiting
Cullman, 35058
Alabama
United States
Novartis Investigative Site
Recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Recruiting
Sarasota, 34233
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33612
Florida
United States
Novartis Investigative Site
Recruiting
West Palm Beach, 33407
Florida
United States
Novartis Investigative Site
Recruiting
Atlanta, 30327
Georgia
United States
Novartis Investigative Site
Recruiting
Honolulu, 96817
Hawaii
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73104
Oklahoma
United States
Australia
Novartis Investigative Site
Recruiting
New Lambton Heights, 2305
New South Wales
Australia
Novartis Investigative Site
Recruiting
Nedlands, 6009
Western Australia
Australia
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Brugge, 8000
-
Belgium
Bulgaria
Novartis Investigative Site
Recruiting
Pleven, 5800
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1113
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1413
-
Bulgaria
Novartis Investigative Site
Recruiting
Sofia, 1431
-
Bulgaria
Czechia
Novartis Investigative Site
Recruiting
Havirov, 736 01
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Hradec Kralove, 500 05
CZE
Czechia
Novartis Investigative Site
Recruiting
Praha, 12808
-
Czechia
Germany
Novartis Investigative Site
Recruiting
Alzenau, 63755
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Bielefeld, D 33647
-
Germany
Novartis Investigative Site
Recruiting
Cottbus, 03048
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04275
-
Germany
Novartis Investigative Site
Recruiting
Minden, 32429
-
Germany
Novartis Investigative Site
Recruiting
Potsdam, 14471
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89073
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89081
-
Germany
Novartis Investigative Site
Recruiting
Unterhaching, 82008
-
Germany
Greece
Novartis Investigative Site
Recruiting
Thessaloniki, 53246
-
Greece
Hungary
Novartis Investigative Site
Recruiting
Budapest, 1204
HUN
Hungary
Novartis Investigative Site
Recruiting
Tatabanya, 2800
Komarom Esztergom
Hungary
Novartis Investigative Site
Recruiting
Pecs, 7623
-
Hungary
Portugal
Novartis Investigative Site
Recruiting
Braga, 4710243
-
Portugal
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 127015
-
Russian Federation
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 813 69
-
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 82606
-
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 83305
-
Slovakia
Novartis Investigative Site
Recruiting
Nitra, 94901
-
Slovakia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08026
Cataluna
Spain
Novartis Investigative Site
Recruiting
Baracaldo, 48903
Vizcaya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28040
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Sancaktepe, 34785
Istanbul
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Samsun, 55139
-
Turkey
Novartis Investigative Site
Recruiting
Trabzon, 61080
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]