A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
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.
- Unknown adverse reactions, especially serious adverse reactions
- Incidences of adverse reactions under routine drug uses
- Factors that may affect the safety of the drug
- 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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Drug Use Investigation of Enbrel for Post-Marketing Surveillance|
|Korea, Republic of|
|Kyunggi-do, Korea, Republic of, 463-712|
|Seoul, Korea, Republic of, 137-807|
|Seoul, Korea, Republic of, 133-792|
|Seoul, Korea, Republic of, 120-752|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|