|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00195416 |
|
Date of registration:
|
12/09/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study Investigating Enbrel Treatment for Ankylosing Spondylitis
|
|
Scientific title:
|
A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis |
|
Date of first enrolment:
|
June 2005 |
|
Target sample size:
|
526 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00195416 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wyeth is now a wholly owned subsidiary of Pfizer |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ankylosing Spondylitis
|
|
Intervention(s)
|
|
Drug: Etanercept
|
|
Secondary ID(s)
|
|
0881A-102018
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|