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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00195403
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 15, 2013
Last Update Posted : August 15, 2013
Information provided by (Responsible Party):

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 19, 2005
Results First Submitted Date June 11, 2013
Results First Posted Date August 15, 2013
Last Update Posted Date August 15, 2013
Study Start Date May 2004
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 11, 2013)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Day 832 ]
    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 ]
    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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: June 11, 2013)
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 ]
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Official Title A Drug Use Investigation of Enbrel for Post-Marketing Surveillance
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic, secondary and tertiary medical centers
Condition Rheumatoid Arthritis
Intervention Drug: Etanercept
Etanercept 25mg Injection, 2 times/week
Study Groups/Cohorts 1
Intervention: Drug: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2013)
Original Enrollment
 (submitted: September 13, 2005)
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.)
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number NCT00195403
Other Study ID Numbers 0881A-101575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date June 2013