Phase
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
Ofatumumab
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written IC must be obtained before participating in the study.
Patients with diagnosis of RMS per McDonald Criteria (2017) and <5 years since firstMS symptom prior to initiation of ofatumumab.
Patients who have been on treatment with ofatumumab for at least 3 months, but notlonger than 6 months prior to inclusion in the study.
Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined byclinical or imaging features).
Patients with at least one available brain MRI scan performed at least 3 monthsafter ofatumumab initiation OR for whom the physician (as per her/his routinepractice and independently of his/her decision to include the patient in the currentstudy) plans to perform such scanning within 31 days after patient's inclusion inthe study. Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In caseit is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatmentshould be brain gadolinium enhanced, for relevant comparison and identification ofnew lesions. This MRI scan will serve as the index reference assessment for theevaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.
Patients willing and able to complete the assessments, including PRO questionnaires,as per physicians' clinical practice and as outlined in this study.
Exclusion
Exclusion Criteria:
Use of investigational drugs during the study, OR between ofatumumab initiation andinclusion into the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until theexpected pharmacodynamic effect has returned to baseline, whichever is longer.
Currently pregnant (or intention to become pregnant within the study period),breastfeeding or lactating women.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Chaidari, Attiki 12462
GreeceSite Not Available
Novartis Investigative Site
Ioannina, Epirus 455 00
GreeceSite Not Available
Novartis Investigative Site
Alexandroupolis, Evros 681 00
GreeceSite Not Available
Novartis Investigative Site
Athens, GR 115 27
GreeceSite Not Available
Novartis Investigative Site
Patras, Peloponissos 265 00
GreeceSite Not Available
Novartis Investigative Site
Larissa, Thessalia 411 10
GreeceSite Not Available
Novartis Investigative Site
Alexandroupoli 736928, 681 00
GreeceActive - Recruiting
Novartis Investigative Site
Athens 264371, 115 21
GreeceActive - Recruiting
Novartis Investigative Site
Chaïdári 260183, 124 62
GreeceActive - Recruiting
Novartis Investigative Site
Crete Heraklion, 714 09
GreeceActive - Recruiting
Novartis Investigative Site
Greece, 53246
GreeceSite Not Available
Novartis Investigative Site
Ioannina 261779, 455 00
GreeceActive - Recruiting
Novartis Investigative Site
Larissa 258576, 411 10
GreeceActive - Recruiting
Novartis Investigative Site
Pátrai 255683, 265 04
GreeceActive - Recruiting
Novartis Investigative Site
Thessaloniki, GR 54636
GreeceSite Not Available
Novartis Investigative Site
Thessaloniki 734077, 53246
GreeceActive - Recruiting

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