Search / Trial NCT00000433

Blocking Tumor Necrosis Factor in Ankylosing Spondylitis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Jan 18, 2000

Trial Information

Current as of December 14, 2024

Completed

Keywords

Spondylitis Etanercept Enbrel Tumor Necrosis Factor Alpha

ClinConnect Summary

In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein (TNFR:Fc, or etanercept) to treat patients with ankylosing spondylitis (AS). TNFR:Fc is an antagonist of tumor necrosis factor (TNF), a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis, rheumatoid arthritis, and vasculitis, as well as other inflammatory conditions.

TNFR:Fc consists of two molecules of the extracellular portion of the p75 receptor, each consisting of 235 amino acids. The two receptors are fused to the Fc portion of human...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of Ankylosing spondylitis
  • Acceptable stable treatments during study: oral glucocorticoids (less than or equal to 10 mg/d) and/or NSAIDs at recommended doses and/or one of the following options: methotrexate (less than or equal to 20.0 mg/week); sulfasalazine (less than or equal to 3 grams/d); azathioprine (less than or equal to 2 mg/kg/d); methotrexate and sulfasalazine combination at doses listed above; 6-mercaptopurine (less than or equal to 1.5 mg/kg/d)
  • Exclusion Criteria:
  • Diagnosis of psoriatic arthritis, inflammatory bowel disease, reactive arthritis, or Behýet disease
  • Significant medical problems, such as diabetes mellitus
  • History of active or recurrent infections
  • Complete ankylosis of the entire spine

Trial Officials

John C. Davis, MD, MPH

Principal Investigator

Division of Rheumatology, University of California - San Francisco Department of Medicine

About National Institute Of Arthritis And Musculoskeletal And Skin Diseases (Niams)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is a pivotal component of the National Institutes of Health (NIH) dedicated to advancing research and knowledge in the fields of arthritis, musculoskeletal disorders, and skin diseases. NIAMS sponsors a wide range of clinical trials aimed at improving the diagnosis, treatment, and prevention of these conditions. By fostering innovative research, collaborating with healthcare professionals, and engaging with patient communities, NIAMS strives to enhance the quality of life for individuals affected by these diseases, while promoting scientific discovery and public health initiatives.

Locations

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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