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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 22 April 2024
Main ID:  EUCTR2019-001341-40-BE
Date of registration: 17/03/2020
Prospective Registration: Yes
Primary sponsor: Novartis Pharma AG
Public title: An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumab
Scientific title: 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
Date of first enrolment: 29/04/2020
Target sample size: 550
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001341-40
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belgium Bulgaria Canada Czech Republic Czechia
Estonia France Germany Greece Hungary Italy Latvia Lebanon
Mexico Norway Poland Portugal Russian Federation Saudi Arabia Slovakia Slovenia
Spain Switzerland Turkey United Kingdom United States
Contacts
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: +41 61 324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Name: Clinical Trial Information Desk   
Address:  Forum 1, Novartis Campus 4056 Basel Switzerland
Telephone: +41 61 324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma AG
Key inclusion & exclusion criteria
Inclusion criteria:
• Diagnosis of MS according to the 2017 Revised McDonald criteria
• Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) (Lublin et al 2014)
• Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
• MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs)
• Subject transitioning from either dimethyl fumarate or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration
• Breakthrough disease activity while the participant was adequately using dimethyl fumarate or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
• Neurologically stable within one month prior to first study drug administration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Subjects with primary progressive MS (Polman et al 2011) or SPMS without disease activity (Lublin et al 2014)
• Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al 2015)
• Disease duration of more than 10 years since diagnosis
• Pregnant or nursing(lactating) women
• Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication
• Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
• Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
• Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
• Subjects at risk of developing or having reactivation of syphilis or tuberculosis
• Subjects at risk of developing or having reactivation of hepatitis: positive results at screening for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
• Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
• Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)
• Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multiple sclerosis
MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: OMB157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod
Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks
Timepoint(s) of evaluation of this end point: 96 weeks
Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: 96 weeks
Secondary end point(s): • Proportion of subjects with adverse events, including injection related reactions
• Proportion of patients with laboratory or vital signs results meeting abnormal criteria
• The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons
Secondary ID(s)
2019-001341-40-CZ
COMB157G23101
Source(s) of Monetary Support
Novartis Pharma AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 29/04/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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