Status:
COMPLETED
16.0040 Ankylosing Spondylitis Study
Lead Sponsor:
Amgen
Collaborating Sponsors:
Immunex Corporation
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
Detailed Description
This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.
Eligibility Criteria
Inclusion
- Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:
- Negative pregnancy test
- Subjects agree to use appropriate contraception throughout study
- Should be able to self-inject study drug or have someone who can do so
- Capable of understanding protocol and willing to provide written informed consent
Exclusion
- Any change in NSAID or prednisone dose within 2 weeks of baseline
- Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline
- Use of DMARDs other than those mentioned above, within 4 weeks of enrollment
- Previous receipt of ani-TNF agents, other than etanercept
- Receipt of any other investigational drug within 30 days of baseline
- Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed
- Abnormality in chemistry or hematology profiles or significant concurrent medical events.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00356356
Start Date
April 1 2002
End Date
September 1 2006
Last Update
May 14 2013
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