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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole body hyperthermia unit

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

K4/666 CSC 600 Highland Av

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M01RR003186

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR03186-9943

Identifier Type: -

Identifier Source: org_study_id