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16.0040 Ankylosing Spondylitis Study

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00356356
First received: July 24, 2006
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356356

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

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

ClinicalTrials.gov processed this record on November 25, 2014