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

Rheumatoid Arthritis Clinical Trial

Official title:

A Drug Use Investigation of Enbrel for Post-Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195403
• Other study ID #: 0881A-101575
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: June 11, 2013
• Start date: May 2004
• Est. completion date: February 2008

Study information

• Verified date: June 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
Etanercept 25mg Injection, 2 times/week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Day 832	Yes
Primary	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.	Baseline, Month 3	No
Secondary	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.	Baseline, Month 3, 9	No