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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00421980 |
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Date of registration:
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08/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
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Scientific title:
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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00421980 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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1. 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.
2. Negative serum ß-HCG pregnancy test at baseline (all women of childbearing
potential).
3. 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.
4. Sexually active men had to agree to use a medically accepted form of contraception
during the study.
5. Able to reconstitute and self-inject test article or have a designee who can do so.
6. Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol-specific procedures were performed.
7. Able to store injectable test article at 2°C to 8°C.
Age minimum:
18 Years
Age maximum:
66 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: Etanercept
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Secondary ID(s)
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0881A3-312
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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