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Procedure
Whole Body Hyperthermia for Rheumatoid Arthritis
N/A
Waitlist Available
Research Sponsored by National Center for Research Resources (NCRR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All candidates must be unsuccessfully treated (lack of efficacy) with at least two of the following disease-modifying antirheumatic drugs: hydroxychloroquine, oral or injectable gold, methotrexate, azathioprine, penicillamine, and sulfasalazine
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether whole body hyperthermia, or heating the body to 41.8 degrees Celsius for 60 minutes, can induce remission in patients with active rheumatoid arthritis by increasing levels of soluble tumor necrosis factor-receptor (sTNF-R).
Who is the study for?
This trial is for people with active rheumatoid arthritis who haven't responded to at least two standard treatments. They must have stable medication doses, a certain level of disease activity, and meet specific heart and lung function criteria. It's not suitable for those with severe organ dysfunction or other conditions outlined in the exclusion criteria.Check my eligibility
What is being tested?
The study tests Whole Body Hyperthermia (WBH) where patients are heated to 41.8C for an hour, aiming to induce TNF receptors which might help treat rheumatoid diseases. The effect on clinical symptoms and various biological markers like cytokine levels will be measured.See study design
What are the potential side effects?
Potential side effects may include discomfort due to high body temperatures such as sweating, dizziness or nausea during the hyperthermia treatment. Long-term side effects are unknown but could relate to changes in immune system responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least two specific drugs for my condition without success.
Select...
My lung function tests show I breathe well enough to join.
Select...
I have 10+ swollen joints, 12+ tender joints, high inflammation or stiffness for 60+ mins.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
317,016 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function tests show I breathe well enough to join.I have tried at least two specific drugs for my condition without success.I have been on a stable dose of NSAIDs or corticosteroids for at least 4 weeks.I have 10+ swollen joints, 12+ tender joints, high inflammation or stiffness for 60+ mins.My blood, liver, and kidney tests are normal.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for this clinical trial above fifty-five years?
"According to the study's specified parameters, participants must be of age 18 or above and no older than 65 years old."
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