Ankylosing SpondylitisNCT00195416
Study Investigating Enbrel Treatment for Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- How many people
- 526 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2005to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, secondary and tertiary medical centers
Who may be able to join
- Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Study site
Gyunggi-do, 463-707
Study site
Seoul, 140-575
Study site
Seoul, 143-914
About this study
Official title: A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
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.
- Unknown adverse reactions, especially serious adverse reactions
- Change of the incidences of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
- Conditions
- Ankylosing Spondylitis
- Being tested
- Etanercept
- Keywords
- Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Etanercept 25mg Injection, 2 times/week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195416
- Sponsor's protocol ID
- 0881A-102018
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2005
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00195416
- Acronym / sponsor ID
- 0881A-102018
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Unknown adverse reactions, especially serious adverse reactions
- Change of the incidences of adverse reactions under the routine drug uses
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, secondary and tertiary medical centers
Key inclusion criteria (1 listed)
- Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptEtanercept 25mg Injection, 2 times/week | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2009.