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Trial NCT00000433

Resource URI: http://static.linkedct.org/resource/trials/NCT00000433
linkedct:brief_title Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
linkedct:condition <http://static.linkedct.org/resource/condition/12378>
linkedct: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
linkedct: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 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 80 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date March 2002
linkedct:enrollment 42 (xsd:int)
linkedct:firstreceived_date January 18, 2000
linkedct:id NCT00000433
rdfs:label Trial NCT00000433
linkedct:lastchanged_date January 2, 2007
linkedct:lead_sponsor_agency National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:location <http://static.linkedct.org/resource/location/216564>
linkedct:nct_id NCT00000433
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Anti-Tumor Necrosis Factor (TNFR:Fc) in Ankylosing Spondylitis
linkedct:org_study_id N01 AR92244
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28648>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000433>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/13340>
linkedct:reference <http://static.linkedct.org/resource/reference/18589>
linkedct:reference <http://static.linkedct.org/resource/reference/19952>
linkedct:secondary_id NIAMS-043
linkedct:source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
linkedct:start_date October 1999
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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 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.
rdf:type linkedct:trials
linkedct:verification_date February 2003