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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Kyunggi-do, , 463-712 Korea, Republic of
Contact
1-800-718-1021
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.)

NCT00195403
Pfizer
Completed
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA

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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Primary care clinic, secondary and tertiary medical centers
Rheumatoid Arthritis
Drug: Etanercept
Etanercept 25mg Injection, 2 times/week
1
Intervention: Drug: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1014
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
4 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00195403
0881A-101575
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
June 2013

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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