Abstract

This is a single site, placebo- controlled, double-blind study to test the efficacy of ENBREL (TNFR:Fc fusion protein) produced by Immunex in patients with ankylosing spondylitis. The protocol involves 40 patients randomized to either placebo or subcutaneous ENBREL twice weekly for 4 months. Outcomes will be measured with standard AS instruments. This is an important study that will provide the rational evidence to support administering ENBREL to AS patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research and Development Contracts (N01)
Project #
N01AR092244-003
Application #
6359383
Study Section
Project Start
1999-09-30
Project End
2002-09-29
Budget Start
2000-09-28
Budget End
2002-09-29
Support Year
Fiscal Year
2000
Total Cost
$146,454
Indirect Cost

  Institution

Name
University of California San Francisco
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143

  Publications

Davis, John C; van der Heijde, Desiree; Dougados, Maxime et al. (2005) Reductions in health-related quality of life in patients with ankylosing spondylitis and improvements with etanercept therapy. Arthritis Rheum 53:494-501
Keller, C; Webb, A; Davis, J (2003) Cytokines in the seronegative spondyloarthropathies and their modification by TNF blockade: a brief report and literature review. Ann Rheum Dis 62:1128-32
Gorman, Jennifer D; Sack, Kenneth E; Davis Jr, John C (2002) Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 346:1349-56