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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00421980
First received: January 8, 2007
Last updated: January 12, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Ankylosing Spondylitis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 84
Study Start Date: June 2002
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
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: NCT00421980

Locations
Belgium
Gent, Belgium, 09000
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421980     History of Changes
Other Study ID Numbers: 0881A3-312
Study First Received: January 8, 2007
Last Updated: January 12, 2007
Health Authority: United Kingdom: Research Ethics Committee

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 20, 2014