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Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis


Phase 2
18 Years
80 Years
Not Enrolling
Both
Spondylitis, Ankylosing

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Trial Information

Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis


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 IgG1,
which consists of 232 amino acids. The gene fragments encoding the truncated TNFR and the Fc
portion of human IgG1 are expressed in a Chinese hamster ovary cell line.

Recent observations from animal and human studies suggest that tumor necrosis factor-alpha
(TNF-alpha) may play a role in disease activity in AS and other seronegative
spondyloarthropathies. This study aims to test the efficacy of TNFR:Fc used in conjunction
with standard medications in the treatment of AS. We will give patients either 25mg of
TNFR:Fc or placebo subcutaneously twice a week for 4 months. Outcome measures will include
measures of function, pain, morning stiffness, patient global assessment, and swollen joint
count, as well as safety measures.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

John C. Davis, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

N01 AR92244

NCT ID:

NCT00000433

Start Date:

October 1999

Completion Date:

March 2002

Related Keywords:

  • Spondylitis, Ankylosing
  • Spondylitis
  • Etanercept
  • ENBREL
  • Tumor necrosis factor-alpha
  • Necrosis
  • Spondylitis
  • Spondylitis, Ankylosing

Name

Location
UCSF-Clinical Trials Center San Francisco, California  94143-0792