A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA

N/ACompletedNCT00195403

Pfizer1,014 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,014

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

Etanercept 25mg Injection, 2 times/week

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

Inclusion Criteria Rheumatoid Arthritis * Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate * Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX Psoriatic Arthritis \- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs Exclusion Criteria * Patients to whom Enbrel is contraindicated as per the local labeling * Patients with known hypersensitivity to Enbrel or any component of the product * Patients with sepsis or risk of sepsis * Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)

Locations (4)

Unnamed facility

Kyunggi-do, South Korea

Unnamed facility

Seoul, South Korea

Unnamed facility

Seoul, South Korea

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

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.

Time frame: Baseline up to Day 832

Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3

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.

Time frame: Baseline, Month 3

Secondary Outcomes

Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9

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.

Time frame: Baseline, Month 3, 9