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16.0040 Ankylosing Spondylitis Study

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ClinicalTrials.gov Identifier: NCT00356356
Recruitment Status : Completed
First Posted : July 26, 2006
Last Update Posted : May 14, 2013
Immunex Corporation
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Etanercept Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Long-term Extension Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis Who Participated in Protocol 16.0037
Study Start Date : April 2002
Primary Completion Date : August 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
Experimental: All subjects
257 subjects
Drug: Etanercept
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

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): NCT00356356

Sponsors and Collaborators
Immunex Corporation
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00356356     History of Changes
Other Study ID Numbers: 20021640
First Posted: July 26, 2006    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors