Phase
Condition
Multiple Sclerosis
Treatment
Inebilizumab
Blood tests
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or above, and able to provide written informed consent and any locallyrequired authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America (USA), European Union [EU] Data PrivacyDirective in the EU) obtained from the subject/legal representative prior toperforming any protocol-related procedures, including screening evaluations.
Have completed at least 2 years in the open-label period of the N-MOmentum study orare newly initiating inebilizumab treatment at a participating site.
Females of childbearing potential who are sexually active with a nonsterilized malepartner must use a highly effective method of contraception as outlined in theprotocol (subjects in the Czech Republic only must use 1 additional method ofcontraception) from screening, and must agree to continue using such precautions for 6 months after treatment with inebilizumab; cessation of contraception after thispoint should be discussed with a responsible physician.
Nonsterilized males who are sexually active with a female partner of childbearingpotential must use a male condom plus spermicide (subjects in the Czech Republiconly must use 1 additional method of contraception) from Day 1 for 3 months afterreceipt of last treatment with inebilizumab.
Sterilized males, without the appropriate post-vasectomy documentation on theabsence of sperm in the ejaculate, who are sexually active with a female partner ofchildbearing potential must use a condom and spermicide from Day 1 for 3 monthsafter receipt of the last treatment with inebilizumab.
Exclusion
Exclusion Criteria:
Have any condition that would place the participant at unacceptable risk ofcomplications, interfere with evaluation of inebilizumab or confound theinterpretation of participant safety or study results.
Received rituximab or any other B-cell depleting agent after exit from N-MOmentumstudy, or within the last 12 months prior to screening for non N-MOmentumparticipants.
Known history of allergy or reaction to any component of inebilizumab formulation orhistory of anaphylaxis following any biologic therapy
Have a severe clinically significant infection, including active chronic infectionsuch as hepatitis B
Have active or untreated latent tuberculosis
Have a history of progressive multifocal leukoencephalopathy (PML)
Is severely immunocompromised state
Have active malignancies
Study Design
Study Description
Connect with a study center
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Ophtalmology
Hong Kong, 0000
ChinaActive - Recruiting
Prince of Wales Hospital - Department of Medicine & Therapeutics
Hong Kong, 0000
ChinaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Praha 2, 128 21
CzechiaActive - Recruiting
Prince of Wales Hospital - Department of Medicine & Therapeutics
Hong Kong, 0000
Hong KongSite Not Available
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong,
Hong KongActive - Recruiting
Prince of Wales Hospital - Department of Medicine & Therapeutics
Hong Kong SAR, 0000
Hong KongSite Not Available
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád 6725
HungaryActive - Recruiting
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
Szeged, 6725
HungaryActive - Recruiting
National Cancer Center - Neurology Clinic
Goyang-si, Gyeonggi-do 10408
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang-si, Gyeonggido [Kyonggi-do] 10408
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 06351
Korea, Republic ofActive - Recruiting
Samsung Medical Center - Pediatric Neurology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp 03080
Korea, Republic ofActive - Recruiting
Uniwersyteckie Centrum Kliniczne WUM
Warszawa, Mazowieckie 02-097
PolandActive - Recruiting
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, Slaskie 40-751
PolandActive - Recruiting
Srinagarind Hospital, Department of Medicine- Faculty of Medicine Khon Kaen University, Academic Clinical Research Office (ACRO)
Mueang, Khon Kaen 40002
ThailandSite Not Available
Khon Kaen University, Srinagarind Hospital
Khon Kaen, 40002
ThailandActive - Recruiting
Khon Kaen University, Srinagarind Hospital
Mueang Khon Kaen, 40002
ThailandSite Not Available
Baylor College of Medicine
Houston, Texas 77030-4202
United StatesActive - Recruiting
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