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|
- Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Day 832 ] [ Designated as safety issue: Yes ]Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.
- Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.
- Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 [ Time Frame: Baseline, Month 3, 9 ] [ Designated as safety issue: No ]Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|Study Start Date:||May 2004|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
|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|