SAP115970: GSK2398852 follow-up study
Research type
Research Study
Full title
SAP115970: An Observational, Non-Interventional Natural History Study of Subjects Receiving GSK2398852
IRAS ID
157068
Contact name
Louise Cookson
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development
Research summary
GlaxoSmithKline (GSK, a pharmaceutical company) is developing new drugs to treat the rare disease systemic amyloidosis. The action of the anti-SAP mAb (GSK2398852) is expected to lead to clearance of amyloid deposits and this has the potential to impact the long term prognosis of patients with systemic amyloidosis. The purpose of this study is to collect natural history data from patients with systemic amyloidosis who have completed GSK-sponsored clinical trial SAP115570 where they received the anti-SAP antibody (GSK2398852 given with the SAP depleter GSK2315698). In addition, clinical data from time of diagnosis will be reported (if available). The findings from this study will provide information on natural history of patients and will assist the design of future clinical studies.
Subjects treated in SAP115570 will be approached and consented to take part. Natural history information from routine clinical care will be collected from time of diagnosis (if available and for up to 5 years following last treatment with the anti-SAP mAb. No additional tests or visits will be conducted as a result of participation in this study.
The study, sponsored by GSK, is conducted in collaboration with the institution providing clinical care for the systemic amyloidosis patients (National Amyloidosis Centre (NAC), Centre for Amyloidosis and Acute Phase Proteins, UCL Division of Medicine, Roral Free Campus, London, UK)REC name
Wales REC 4
REC reference
14/WA/1130
Date of REC Opinion
10 Sep 2014
REC opinion
Further Information Favourable Opinion