Official Title: “Open-Label, Long-Term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037”

The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Etanercept
  • Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: All subjects
  • 257 subjects

Primary Measures

• Treatment Response (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in at least 3 of the 4 domains
  • Time Frame: Up to 4 years
    Safety Issue?: No
• Absence of deterioration (using ASAS criteria) of at least 20% and absolute improvement of at least 10 units on a 0-100 scale in the potential remaining ASAS domain
  • Time Frame: Up to 4 years
    Safety Issue?: No

Secondary Measures

• DXA and MRI scans (at selected sites)
  • Time Frame: Up to 144 weeks
    Safety Issue?: No
• X-rays of cervical spine and lumbosacral spine
  • Time Frame: Up to 4 years
    Safety Issue?: No
• Type and grade of toxicities
  • Time Frame: Up to 4 years
    Safety Issue?: No
• ASAS Response Criteria at weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, and the ASAS Response Criteria at 50% and 70% levels at weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 144.
  • Time Frame: Up to 4 years
    Safety Issue?: No
• Frequency and time to partial remission as defined in Anderson, 2001: Value of <20 (on a scale of 0-100) in each of the following 4 domains: VAS Patient Global Assessment, VAS Pain Score, BASFI, and BASDAI morning stiffness-related scores
  • Time Frame: Up to 4 years
    Safety Issue?: No
• Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance
  • Time Frame: Up to 120 weeks
    Safety Issue?: No
• Complete joint assessment
  • Time Frame: Up to 120 weeks
    Safety Issue?: No
• Laboratory assessment of inflammation using CRP
  • Time Frame: Up to 120 weeks
    Safety Issue?: No
• Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate
  • Time Frame: Up to 4 years
    Safety Issue?: No

• Inclusion Criteria: - 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 Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Amgen

Overall Clinical Trial Officials and Contacts

MD Study Director Amgen  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356356

Study ID Number: 20021640

ClinicalTrials.gov Identifier: NCT00356356

Health Authority: Canada: Health Canada

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