Status:
COMPLETED
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 t...
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
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00000433
Start Date
October 1 1999
End Date
March 1 2002
Last Update
January 4 2007
Active Locations (1)
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1
UCSF-Clinical Trials Center
San Francisco, California, United States, 94143-0792