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41.8 Degree Centigrade Whole Body Hyperthermia for the Treatment of Rheumatoid Diseases

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ClinicalTrials.gov Identifier: NCT00000106
Recruitment Status : Unknown
Verified November 2000 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Device: Whole body hyperthermia unit Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000106


Locations
United States, Wisconsin
K4/666 CSC 600 Highland Av
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Center for Research Resources (NCRR)

ClinicalTrials.gov Identifier: NCT00000106     History of Changes
Other Study ID Numbers: NCRR-M01RR03186-9943
M01RR003186 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2000

Keywords provided by National Center for Research Resources (NCRR):
Rheumatoid Diseases

Additional relevant MeSH terms:
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases