Overview

This trial is active, not recruiting.

Condition rheumatic diseases
Treatment whole body hyperthermia unit
Sponsor National Center for Research Resources (NCRR)
Trial identifier NCT00000106, M01RR03186, NCRR-M01RR03186-9943

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).