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

NCT00195403

Last updated date
Study Location
Kyunggi-do, , 463-712, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.)

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Advanced Information
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 11, 2013)
1014
Original Enrollment
 (submitted: September 13, 2005)
600
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.)
Sex/Gender
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
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date June 2013