Study to assess Ofatumumab in patients with relapsing multiple sclerosis

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 (ICTRP)

ID di studio ICTRP
EUCTR2019-001341-40 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod (BASEC)

Titolo accademico
A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis(RMS) transitioning from fumarate-based RMS approved therapies or fingolimod (ICTRP)

Titolo pubblico
An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumab (ICTRP)

Malattie studiate
Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] (ICTRP)

Intervento studiato

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-

(ICTRP)

Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)

Disegno dello studio
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 (ICTRP)

Criteri di inclusione/esclusione
Gender:
Female: yes
Male: yes

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), where all fumarates are considered as one DMT
? Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate
(DRF), 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 fumarates 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
Please see protocol for complete detailed list of inclusion criteria.
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 555
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
(ICTRP)

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 (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice
? Subjects with active hepatitis B and C disease, assessed locally
? 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
Please see protocol for complete detailed list of exclusion criteria.


Endpoint primari e secondari
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 fumarates or fingolimod;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 fumarates 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 (ICTRP)

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;Timepoint(s) of evaluation of this end point: 96 weeks (ICTRP)

Data di registrazione
11.03.2020 (ICTRP)

Inclusione del primo partecipante
29.04.2020 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Clinical Trial Information Desk, clinicaltrial.enquiries@novartis.com, +41 61 32 41111, Novartis Pharma AG (ICTRP)

ID secondari
COMB157G23101, 2019-001341-40-CZ (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001341-40 (ICTRP)