Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha.
Jennifer D Gorman, Kenneth E Sack, John C Davis
https://pubmed.ncbi.nlm.nih.gov/11986408Completed
Phase 2
Age: 18Years - 80Years
All Genders
ID00000433
Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis
Led by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Updated on 2007-01-04
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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 Site Locations
Total: 1 location
1
UCSF-Clinical Trials Center
San Francisco, California, United States, 94143-0792
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial.
John C Davis, Désirée Van Der Heijde, Jurgen Braun...
https://pubmed.ncbi.nlm.nih.gov/14613288New therapies for ankylosing spondylitis: etanercept, thalidomide, and pamidronate.
John C Davis, Feng Huang, Walter Maksymowych
https://pubmed.ncbi.nlm.nih.gov/12951863