Phase
Condition
Memory Loss
Multiple Sclerosis
Neurologic Disorders
Treatment
Ofatunumab
Clinical Study ID
Ages 18-100 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent must be obtained before any study assessment is performed.
Participant is female with a relapsing form of MS and at least 18 years of age atthe time of providing consent.
Participant must be postpartum at the time of enrollment, plan to be exclusivelybreastfeeding and willing to provide breast milk samples.
Participant has delivered term infant (at least 37 weeks gestation).
Participant must plan to initiate or re-initiate or have initiated or re-initiatedtreatment with ofatumumab between 2 to 24 weeks postpartum. The decision to betreated with ofatumumab and to breastfeed is made in accordance with the treatingphysician and must be completely independent of the decision to participate in thisstudy.
Exclusion
Exclusion Criteria:
Use of any investigational drugs within 5 half-lives of enrollment, or within 30days or until the expected pharmacodynamic effect has returned to baseline,whichever is longer.
Participant taking medications prohibited by the study protocol at screening.
Pregnant woman, confirmed by positive serum pregnancy test during screening.
Female of childbearing potential should use effective contraception as per locallabel.
Participant has history of chronic alcohol abuse or drug abuse in the last year.
Participant has any medical, obstetrical, psychiatric or other medical conditionthat, in the opinion of the Investigator, can jeopardize or would compromise thesubject's ability to participate in this study or confound the study assessment.
Participant has history of breast implants, breast augmentation, or breast reductionsurgery.
Participant has received anti-CD20 agents during the second and third trimesters ofpregnancy.
Active infections, including mastitis (participant may be included once theinfection is resolved).
Prior or current history of primary or secondary immunodeficiency, or participant inan otherwise severely immunocompromised state.
Participant with active hepatitis B disease prior to the initiation or re-initiationof ofatumumab. (Participant with positive hepatitis B serology should consult aliver disease medical standards to prevent hepatitis B reactivation.)
History of malignancy of any organ system (other than localized basal cell carcinomaof the skin or in situ cervical cancer), treated or untreated, within the past 5years, regardless of whether there is evidence of local recurrence or metastases.
Any contraindication as per local label.
Participant who has an infant with any abnormality that may interfere withbreastfeeding or confound the study assessment in the opinion of the Investigator.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Bochum, 44791
GermanyActive - Recruiting
Novartis Investigative Site
Hamburg, 22179
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81377
GermanyActive - Recruiting
Novartis Investigative Site
Tuebingen, 72076
GermanyActive - Recruiting
Caribbean Center for Clinical Research, Inc
Guaynabo, 00968
Puerto RicoActive - Recruiting
Novartis Investigative Site
London, NW1 2BU
United KingdomActive - Recruiting
Novartis Investigative Site
Salford, M6 8HD
United KingdomActive - Recruiting
UCSF
San Francisco, California 94115
United StatesActive - Recruiting
UCSF .
San Francisco, California 94115
United StatesActive - Recruiting
UC Health Neuroscience Ctr
Aurora, Colorado 80045
United StatesActive - Recruiting
Northwestern Medicine Northwestern University
Winfield, Illinois 60190
United StatesActive - Recruiting
Brigham and Womens Hospital
Brookline, Massachusetts 02445
United StatesActive - Recruiting
Duke Neurology
Durham, North Carolina 27110
United StatesActive - Recruiting
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