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Completed

NCT Number: NCT00356356

16.0040 Ankylosing Spondylitis Study

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

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etanercept

Drug

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. DXA and MRI scans (at selected sites)

    Time frame: Up to 144 weeks

  2. X-rays of cervical spine and lumbosacral spine

    Time frame: Up to 4 years

  3. Type and grade of toxicities

    Time frame: Up to 4 years

  4. 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

  5. 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

  6. Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance

    Time frame: Up to 120 weeks

  7. Complete joint assessment

    Time frame: Up to 120 weeks

  8. Laboratory assessment of inflammation using CRP

    Time frame: Up to 120 weeks

  9. Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Immunex Corporation

Registry information

Official study title

Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jul 26, 2006
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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