In addition to sharing technical results summaries on clinicaltrials.gov and eudract.ema.europa.eu (EudraCT), Amgen has committed to publicly disclose a synopsis of each clinical study report (CSR Synopsis) for Amgen-sponsored trials included in the marketing application beginning with new product approvals in 2015. For new products filed in the U.S. and EU after January 1, 2014, CSR synopses will be posted publicly on the Amgen portal within a reasonable time after regulatory approval in the later region.
The CSR synopses will be redacted to remove commercially confidential or personally identifying patient information before posting on AmgenTrials.com.
Additionally, Amgen is also committed to publicly share available CSR Synopses retrospectively to 2004. The postings will be done in a step-wise manner by 2017.
This information is intended to satisfy public disclosure commitments and shall not be used for any other purpose. It shall also not be considered to be a claim for any marketed product. Some information in this document may differ from, or not be included in, the approved labeling for the product. Please refer to the full prescribing information for indications and proper use of the product.
To locate the CSR synopsis for a particular clinical trial, please click on the name of the product of interest below. You will be taken to a list of clinical trials by product from where you can select the particular clinical trial of interest by the study number and title. Please note the list of products will be visible as the CSR synopses are made available.Product List