16.0040 Ankylosing Spondylitis Study

This study has been completed.
Immunex Corporation
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 24, 2006
Last updated: May 10, 2013
Last verified: May 2013

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

Condition Intervention Phase
Ankylosing Spondylitis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DXA and MRI scans (at selected sites) [ Time Frame: Up to 144 weeks ] [ Designated as safety issue: No ]
  • X-rays of cervical spine and lumbosacral spine [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Type and grade of toxicities [ Time Frame: Up to 4 years ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Spinal mobility measured with Schober's test, chest expansion, and occiput to wall distance [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • Complete joint assessment [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • Laboratory assessment of inflammation using CRP [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • Ability to reduce and discontinue concomitant NSAIDs, prednisone, hydroxychloroquine, sulfasalazine, and methotrexate [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: April 2002
Study Completion Date: September 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
257 subjects
Drug: Etanercept
Etanercept 50 mg/wk administered as 2-25 mg SQ injections at separate injection sites

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356356

Sponsors and Collaborators
Immunex Corporation
Study Director: MD Amgen
  More Information

Additional Information:
Additional 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, 016.0040
Study First Received: July 24, 2006
Last Updated: May 10, 2013
Health Authority: Canada: Health Canada
Europe: EMEA
United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014