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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00444340
First received: March 5, 2007
Last updated: December 5, 2007
Last verified: December 2007
  Purpose

This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Enbrel (Etanercept)
Phase 4

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: 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:

Primary Outcome Measures:
  • To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.

Secondary Outcome Measures:
  • To assess the long-term clinical efficacy of etanercept in these study subjects.

Estimated Enrollment: 70
Study Start Date: April 2004
Study Completion Date: July 2007
  Eligibility

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

Inclusion Criteria:

  • Completed study 0881A3-312-EU
  • Agreeable to utilize medically acceptable form of contraception
  • Able to reconstitute and self-inject or have a designee

Exclusion Criteria:

  • Withdrawn from study 0881A3-312-EU
  • Abnormal hematology or chemistry profiles
  • Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444340

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

ClinicalTrials.gov Identifier: NCT00444340     History of Changes
Other Study ID Numbers: 0881A3-101615
Study First Received: March 5, 2007
Last Updated: December 5, 2007
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Finland: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ministry of Health
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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