Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
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Purpose
The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis (AS) with a new therapy currently used for people with other forms of arthritis. The drug, called Enbrel (or etanercept), is a protein that is given twice weekly by injection underneath the skin. It blocks the action of tumor necrosis factor-alpha (TNF-alpha), a substance that may be involved in AS, rheumatoid arthritis, and other inflammatory conditions. We will randomly assign patients to receive either the drug or a placebo (inactive treatment) for 4 months. The results we will monitor include morning stiffness, spinal mobility, activities of daily life, and safety of the drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Spondylitis, Ankylosing |
Drug: Anti-Tumor Necrosis Factor |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis |
| Estimated Enrollment: | 42 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | March 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| UCSF-Clinical Trials Center | |
| San Francisco, California, United States, 94143-0792 | |
| Principal Investigator: | John C. Davis, MD, MPH | Division of Rheumatology, University of California - San Francisco Department of Medicine |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00000433 History of Changes |
| Other Study ID Numbers: | N01 AR92244, NIAMS-043 |
| Study First Received: | January 18, 2000 |
| Last Updated: | January 2, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Spondylitis Etanercept ENBREL Tumor necrosis factor-alpha |
Additional relevant MeSH terms:
|
Necrosis Spondylitis Spondylitis, Ankylosing Pathologic Processes Bone Diseases, Infectious Infection Bone Diseases |
Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis |
ClinicalTrials.gov processed this record on June 18, 2013