Clinical Trials Logo
  1. Home
  2. Ankylosing Spondylitis
  3. NCT00444340
  4. Details
NCT00444340 Clinical Trial

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

Ankylosing Spondylitis Clinical Trial

Official title:
An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00444340
Other study ID # 0881A3-101615
Secondary ID
Status Completed
Phase Phase 4
First received March 5, 2007
Last updated December 5, 2007
Start date April 2004
Est. completion date July 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministry of Social Affairs, Public Health and the EnvironmentFinland: Ethics CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Spain: Ministry of HealthUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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- Withdrawn from study 0881A3-312-EU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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Enbrel (Etanercept)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary To assess the long-term clinical efficacy of etanercept in these study subjects.
See also
  Status Clinical Trial Phase
Terminated NCT02685904 - A Multicentre Study to Evaluate the Efficacy and Safety of ENIA11 in Patients With Ankylosing Spondylitis Phase 3
Completed NCT02186873 - A Study of Golimumab in Participants With Active Ankylosing Spondylitis Phase 3
Completed NCT01668004 - The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Phase 4
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Completed NCT01934933 - Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis Phase 4
Not yet recruiting NCT04875299 - Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients
Completed NCT02758782 - NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis Phase 4
Completed NCT02763111 - Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of Various Doses of BCD-085 in Patients With Active Ankylosing Spondylitis Phase 2
Active, not recruiting NCT02687620 - Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study
Completed NCT02154425 - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Phase 1
Completed NCT01750528 - Prevalence and Progression of Periodontitis in Ankylosing Spondylitis N/A
Completed NCT01463189 - Web-based Support to Manage Arthritis Pain Phase 2
Completed NCT01091675 - Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Phase 3
Completed NCT00844805 - Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Phase 3
Recruiting NCT00747578 - Health-Related Quality of Life and Disease-Related Costs: Comparison Between Ankylosing Spondylitis, Rheumatoid Arthritis and Systemic Lupus Erythematosus in Taiwan N/A
Completed NCT00715091 - Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis Phase 4
Completed NCT01083693 - Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs N/A
Not yet recruiting NCT00517101 - Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy N/A
Completed NCT00367211 - Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. Phase 3
Completed NCT00133315 - TNFalfa Blocking Treatment of Spondylarthropathies Phase 4