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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2000 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000106
First Posted: January 19, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Research Resources (NCRR)
  Purpose
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 Intervention
Rheumatic Diseases Device: Whole body hyperthermia unit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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)
  More Information

ClinicalTrials.gov Identifier: NCT00000106     History of Changes
Other Study ID Numbers: NCRR-M01RR03186-9943
M01RR003186 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2000
First Posted: January 19, 2000
Last Update Posted: December 9, 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