A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
The objective of this investigation is to identify the following problems and questions with
respect to the safety and efficacy of Enbrel during the post-marketing period as required by
Korea Food and Drug Administration (KFDA)'s regulation.
1. Unknown adverse reactions, especially serious adverse reactions
2. Incidences of adverse reactions under routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the efficacy of the drug
This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403,
0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have
been combined into this record.