An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
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|ClinicalTrials.gov Identifier: NCT00421980|
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : January 15, 2007
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|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: Etanercept||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis|
|Study Start Date :||June 2002|
|Study Completion Date :||July 2004|
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|Ages Eligible for Study:||18 Years to 66 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
- Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
- Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
- Sexually active men had to agree to use a medically accepted form of contraception during the study.
- Able to reconstitute and self-inject test article or have a designee who can do so.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
- Able to store injectable test article at 2°C to 8°C.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421980
|Gent, Belgium, 09000|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Other Study ID Numbers:||
|First Posted:||January 15, 2007 Key Record Dates|
|Last Update Posted:||January 15, 2007|
|Last Verified:||January 2007|
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