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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00421980
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : January 15, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

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

Detailed Description:
This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Study Start Date : June 2002
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  1. Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
  2. Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
  3. Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
  4. Sexually active men had to agree to use a medically accepted form of contraception during the study.
  5. Able to reconstitute and self-inject test article or have a designee who can do so.
  6. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
  7. Able to store injectable test article at 2°C to 8°C.
Contacts and Locations
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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): NCT00421980


Locations
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Belgium
Gent, Belgium, 09000
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00421980    
Other Study ID Numbers: 0881A3-312
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Axial Spondyloarthritis
Spondylarthropathies
Ankylosis
 Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors