Blocking Tumor Necrosis Factor in Ankylosing Spondylitis

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

Keywords

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