Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis
18 Years
80 Years
Both
Spondylitis, Ankylosing
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 |
