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Trial NCT00000106

Resource URI: http://static.linkedct.org/resource/trials/NCT00000106
linkedct:brief_title 41.8 Degree Centigrade Whole Body Hyperthermia for the Treatment of Rheumatoid Diseases
linkedct:condition <http://static.linkedct.org/resource/condition/11604>
linkedct:criteria Inclusion Criteria: - Patients are required to meet the criteria of the American College of Rheumatology (ACR)for rheumatoid arthritis. - Patients should be in functional class II, or III according to the criteria of the ACR. - All candidates must be unsuccessfully treated (lack of efficacy) with at least two of the following disease-modifying antirheumatic drugs: hydroxychloroquinine, oral or injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine. - Patients receiving nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids (<= 10 mg per day), or both are eligible if the dosage has been stable for at least four weeks before treatment and remained so throughout the study and follow-up period (the use of narcotics for pain flares is allowed). - The necessary degree of disease activity at enrollment should be confirmed by a finding of 10 or more swollen joints, 12 or more tender joints, and one of the following two criteria: a Westergren erythrocyte sedimentation rate of at least 28 mm per hour or a serum C-reactive protein level of more than 2.0 mg per deciliter; or morning stiffness for at least 60 minutes. - Patients must have adequate bone marrow function, adequate liver function, adequate renal function, calcium and electrolytes. - Patients must have a dobutamine stress ECHO, or exercise cardiac MUGA, or exercise ECHO scan prior to entry and must fulfill certain criteria to be eligible. The spirit of the criteria are to rule out organic heart disease. - Respiratory status: Patients who have FEV1 of >= 60% of predicted, as well as a maximum voluntary volume (MVV) of >= 60% of predicted, and blood gases with a PO2 of >= 60 or oxygen saturation of >= 90% are eligible.
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 65 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date January 18, 2000
linkedct:id NCT00000106
rdfs:label Trial NCT00000106
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Center for Research Resources (NCRR)
linkedct:location <http://static.linkedct.org/resource/location/189201>
linkedct:nct_id NCT00000106
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NCRR-M01RR03186-9943
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000106>
linkedct:phase N/A
linkedct:secondary_id M01RR03186
linkedct:source National Center for Research Resources (NCRR)
linkedct:study_design Treatment, Randomized, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary Recently a non-toxic system for whole body hyperthermia (WBH) used at the University of Wisconsin has been shown to induce soluble tumor necrosis factor-receptor (sTNF-R) I and II when patients are heated systemically to 41.8C for 60 minutes. This observation might provide a biological basis for the therapeutic application of WBH to rheumatoid diseases, for which there is a positive anecdotal clinical experience. Inherent in the hypothesis which is the basis for this protocol is the concept that the induction of TNF receptors by WBH may induce a remission in patients with active rheumatoid arthritis. Beyond clinical response the biological endpoint for this investigation includes cytokine levels, TNF levels, sTNF-R levels and changes in cellular TNF receptors.
rdf:type linkedct:trials
linkedct:verification_date November 2000