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Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Last updated on November 29, 2019

FOR MORE INFORMATION
Study Location
Gyunggi-do, , 463-707 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately
to previous therapy

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

- 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.

NCT00195416
Pfizer
Completed
Study Investigating Enbrel Treatment for Ankylosing Spondylitis

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Descriptive Information
Brief TitleStudy Investigating Enbrel Treatment for Ankylosing Spondylitis
Official TitleA Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
Brief Summary

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

  1. Unknown adverse reactions, especially serious adverse reactions
  2. Change of the incidences of adverse reactions under the routine drug uses
  3. Factors that may affect the safety of the drug
  4. Factors that may affect the effectiveness of the drug
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPrimary care clinic, secondary and tertiary medical centers
ConditionAnkylosing Spondylitis
InterventionDrug: Etanercept
Etanercept 25mg Injection, 2 times/week
Study Groups/CohortsNot Provided
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 StatusCompleted
Actual Enrollment
 (submitted: September 15, 2009)
526
Original Enrollment
 (submitted: September 13, 2005)
750
Actual Study Completion DateAugust 2008
Actual Primary Completion DateAugust 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195416
Other Study ID Numbers0881A-102018
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateSeptember 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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