Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
Completed
Human Genome Sciences Inc.
Phase 2
2010-03-01
Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF
(BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis
of SS in both systemic and glandular features, and B cell downregulation may lead to a
decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic
lupus erythematosus, where Belimumab has been proven to be effective.
Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome
Completed
Assistance Publique - Hôpitaux de Paris
Phase 2
2010-03-01
Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF
(BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis
of SS in both systemic and glandular features, and B cell downregulation may lead to a
decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic
lupus erythematosus, where Belimumab has been proven to be effective.
This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and
pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who
have received commercially supplied belimumab within the 4 months prior to and/or during
pregnancy. The registry will also evaluate outcomes of infants born to mothers who were
exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will
add to the current clinical experience with belimumab and will complement reproductive data
from animal toxicology studies. It will also assist clinicians in weighing the potential
risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline
(GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing
Authorization.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.