Phase
Condition
Memory Loss
Neurologic Disorders
Scar Tissue
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
Munich, Bavaria 81377
GermanySite Not Available
Novartis Investigative Site
Munich 2867714, Bavaria 2951839 81377
GermanySite Not Available
Novartis Investigative Site
Bochum, 44791
GermanySite Not Available
Novartis Investigative Site
Bochum 2947416, 44791
GermanySite Not Available
Novartis Investigative Site
Hamburg, 22179
GermanySite Not Available
Novartis Investigative Site
Hamburg 2911298, 22179
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81377
GermanySite Not Available
Novartis Investigative Site
Tuebingen, 72076
GermanySite Not Available
Novartis Investigative Site
Tübingen, 72076
GermanySite Not Available
Novartis Investigative Site
Tübingen 2820860, 72076
GermanySite Not Available
Novartis Investigative Site
Foggia, FG 71122
ItalySite Not Available
Novartis Investigative Site
Foggia 3176885, FG 71122
ItalySite Not Available
Novartis Investigative Site
Roma 8957247, RM 00133
ItalySite Not Available
Novartis Investigative Site
Torino 8980539, TO 10126
ItalySite Not Available
Novartis Investigative Site
Bialystok, 15 276
PolandSite Not Available
Novartis Investigative Site
Bialystok 776069, 15 276
PolandSite Not Available
Novartis Investigative Site
Kielce, 25 726
PolandSite Not Available
Novartis Investigative Site
Kielce 769250, 25 726
PolandSite Not Available
Novartis Investigative Site
Krakow, 31 531
PolandSite Not Available
Novartis Investigative Site
Krakow 3094802, 31 531
PolandSite Not Available
Novartis Investigative Site
Rzeszow, 35-323
PolandSite Not Available
Novartis Investigative Site
Rzeszów 759734, 35-323
PolandSite Not Available
Novartis Investigative Site
Zabrze 3080985, 41-800
PolandSite Not Available
Caribbean Center for Clinical Research, Inc
Guaynabo, 00968
Puerto RicoSite Not Available
Caribbean Center for Clinical Research, Inc
Guaynabo 4565119, 00968
Puerto RicoSite Not Available
Novartis Investigative Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
Novartis Investigative Site
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
Novartis Investigative Site
London, NW1 2BU
United KingdomSite Not Available
Novartis Investigative Site
London 2643743, NW1 2BU
United KingdomSite Not Available
Novartis Investigative Site
Oxford, OX3 9DU
United KingdomSite Not Available
Novartis Investigative Site
Oxford 2640729, OX3 9DU
United KingdomSite Not Available
Novartis Investigative Site
Salford, M6 8HD
United KingdomSite Not Available
Novartis Investigative Site
Salford 2638671, M6 8HD
United KingdomSite Not Available
UCSF
San Francisco, California 94115
United StatesSite Not Available
UCSF .
San Francisco, California 94115
United StatesActive - Recruiting
UCSF
San Francisco 5391959, California 5332921 94115
United StatesSite Not Available
UC Health Neuroscience Ctr
Aurora, Colorado 80045
United StatesSite Not Available
UC Health Neuroscience Ctr
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Northwestern Medicine Northwestern University
Winfield, Illinois 60190
United StatesSite Not Available
Northwestern Medicine Northwestern University
Winfield 4916826, Illinois 4896861 60190
United StatesSite Not Available
Brigham and Womens Hospital
Brookline, Massachusetts 02445
United StatesSite Not Available
Brigham and Womens Hospital
Brookline 4931482, Massachusetts 6254926 02445
United StatesSite Not Available
Duke Neurology
Durham, North Carolina 27110
United StatesSite Not Available
Duke Neurology
Durham 4464368, North Carolina 4482348 27110
United StatesSite Not Available

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