Active Stimulation for Rheumatoid Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pinnacle Research Group, LLC, Anniston, AL
Rheumatoid Arthritis+2 More
Active Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the Galvani System is safe and tolerable for people with rheumatoid arthritis.

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Eligible Conditions

  • Rheumatoid Arthritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Rheumatoid Arthritis

Study Objectives

This trial is evaluating whether Active Stimulation will improve 2 primary outcomes and 21 secondary outcomes in patients with Rheumatoid Arthritis. Measurement will happen over the course of Time Frame: Week 24.

Week 12
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score
Change in Short Form 36 (SF-36) physical component score
Change in the 28 Joint Disease Activity Score 28 - C reactive protein (DAS28-CRP)
Change in the level of Lipopolysaccharide (LPS)-inducible release of Tumor Necrosis Factor (TNFα) in whole blood assay
Week 24
Change in the level of LPS-inducible release of IL-17 in whole blood assay
Change in the level of LPS-inducible release of IL-8 in whole blood assay
Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay
Change in the level of LPS-inducible release of TNFα in whole blood assay
Week 48
Change in DAS28-CRP
Change in HAQ-DI score
Change in SF-36 domain score
Change in SF-36 mental component score
Change in SF-36 physical component score
Year 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Through 48 weeks
Evaluate device performance as assessed by tabulation of device deficiencies
To evaluate the participants' perception of therapy and sensation
To evaluate the usability of the external Galvani System devices and accessories
Time Frame: Week 24
Incidence of participants who remain on active stimulation achieving DAS28-CRP score <2.6 at the end of Period 2
Week 12
Incidence of Adverse Events [Safety and Tolerability]
Week 24
Incidence of participants who are given drug treatment with baricitinib achieving DAS28-CRP score <2.6 at the end of Period 2
Week 24
Change in DAS28-CRP in participants who are given Drug treatment with baricitinib during Period 2
Change in DAS28-CRP in participants who remain on active stimulation during Period 2
Incidence of a change in DAS28-CRP greater than 1.2 units in participants who are given Drug treatment with baricitinib during Period 2

Trial Safety

Safety Progress

1 of 3

Other trials for Rheumatoid Arthritis

Trial Design

5 Treatment Groups

Open label active stimulation, Period 2
1 of 5
Active Stimulation; Period 1
1 of 5
RA drug combined with active stimulation, Period 3
1 of 5
Active stimulation combined with RA drug, Period 3
1 of 5
Sham Stimulation; Period 1
1 of 5
Experimental Treatment
Non-Treatment Group

This trial requires 28 total participants across 5 different treatment groups

This trial involves 5 different treatments. Active Stimulation is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Open label active stimulation, Period 2Open label active stimulation for 12 additional weeks in addition to stable dose of csDMARD therapy.
Active Stimulation; Period 1Active stimulation for 12 weeks in addition to stable dose of csDMARD therapy.
RA drug combined with active stimulation, Period 3Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks. Participants will also receive a stable dose of csDMARD therapy.
Active stimulation combined with RA drug, Period 3Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks. Participants will also receive a stable dose of csDMARD therapy.
Sham Stimulation; Period 1Sham stimulation for 12 weeks in addition to stable dose of csDMARD therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during period 4 (period 4 is up to 5 years in duration beyond period 3)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during period 4 (period 4 is up to 5 years in duration beyond period 3) for reporting.

Closest Location

Pinnacle Research Group, LLC - Anniston, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If you have been using a biological DMARD or JAK inhibitor in the past, you will need to have an appropriate washout period before you can start taking Leflunomide. show original
If you are being treated with standard doses of synthetic DMARDs, your doctor will likely prescribe one or more of the following medications: methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine. show original
Adult-onset RA of at least six months duration
Male or female participants, 22-75 years of age
Active RA
The person has not responded well to at least two biologic therapies, such as DMARDs or JAK inhibitors, including at least one TNF inhibitor. show original

Patient Q&A Section

What are the common side effects of active stimulation?

"Active intervention is not without risk; common side effects of physical movement should be considered especially when new patients are starting active intervention in the clinic." - Anonymous Online Contributor

Unverified Answer

Can arthritis be cured?

"The current study does not support the claims that CBD can cure arthritis. CBD does have a positive effect on osteoarthritis as was the original study with RA patients." - Anonymous Online Contributor

Unverified Answer

What causes arthritis?

"There are no known causes of arthritis. There are no known common causes of arthritis in one part of the body and other parts of the body." - Anonymous Online Contributor

Unverified Answer

What are the signs of arthritis?

"Signs and symptoms of arthritis can include swelling, warmth, and painful joints. A patient may exhibit joint instability, such as falling more than once with minimal contact. Itchiness can also be a symptom of arthritis. Arthritis symptoms can be worse on warmer days, and can be relieved by heat or cold. A patient can have joint dysfunction that is difficult to determine because of the body's natural protective mechanism that is to limit the amount of friction between the joint in question and surrounding parts." - Anonymous Online Contributor

Unverified Answer

What is arthritis?

"Arthritis is a chronic inflammatory disease whose main symptoms are redness, heat, swelling, and stiffness, plus the possible development of joint pain, swelling of the small joints of the hand or foot, and deformation of the affected joints. Because arthritis is a chronic ailment, it is not known for sure who develops the disorder." - Anonymous Online Contributor

Unverified Answer

How many people get arthritis a year in the United States?

"The occurrence of rheumatoid arthritis in the United States is low (i.e., 15.1 per 100,000 persons per year) compared with figures for other Western countries like Germany (50 to 100 per 100,000 persons annually). Only persons 45 years old and older have a high probability of developing rheumatoid arthritis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for arthritis?

"Arthritis can be treated with both nonpharmacological and pharmacological treatments. Nonpharmacological treatments are beneficial for both chronic and acute forms of arthritis. One example is exercise to decrease pain and stiffness. Pharmacological treatments are typically prescribed for arthritis and can be beneficial for both acute and chronic forms of arthritis. Examples of medications that can help are antiplatelet medications such as aspirin and nonsteroidal anti-inflammatory drugs; steroids are prescribed to treat chronic inflammation. These treatments can help reduce pain and swelling for chronic arthritis. Treatments can also be used to treat rheumatoid arthritis." - Anonymous Online Contributor

Unverified Answer

Is active stimulation safe for people?

"In a recent study, findings showed that even vigorous physical activity after an episode of acute swelling has not been shown to have any adverse effect. The study showed that the active stimulus was safe for the patient from the point of view of recovery, but the duration of recovery varied with the intensity and velocity of exercise." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for arthritis?

"Few patients with new-onset RA would consider clinical trials, mainly because of the side-effects. Trial participation should be promoted by considering patient's preferences and the necessity of early treatment." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets arthritis?

"There is no consensus of data available regarding the average age at which people develop active [rheumatoid arthritis](https://www.withpower.com/clinical-trials/rheumatoid-arthritis) (RA). It is likely the disease will develop during the third decade of life. There have also been reports of RA being diagnosed in infants. There is a need for further research into the exact age a patient is diagnosed with RA. Arthritis and RA in infants is a relatively uncommon and sometimes devastating combination that poses unique challenges for treatment and diagnosis. This report describes such a case. It highlights the need for more research and a global consensus on diagnostic and treatment protocols." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving active stimulation?

"There have been only 7 small trials (total participants ranged from 100-204 persons) in evaluating active stimulation to treat Rheumatoid Arthritis. One of them found some supporting data for the benefit of passive stimulation (repetition of movements) in RA and another two have not shown convincing evidence. Thus, the active stimulation in Rheumatoid Arthritis is still not proven so far. Nevertheless, this small subgroup of reports is still helpful to get insight at least. This is due to the fact that most of the reports are small, with only few participants, but also because they were all from the same time period." - Anonymous Online Contributor

Unverified Answer

What does active stimulation usually treat?

"Activated skeletal muscle in athletes improves strength of quadriceps muscle and enhances recovery of walking ability in patients with chronic arthritis of the knee. Improved walking ability may benefit some patients with chronic arthritis of the hip, but the effect is smaller and requires further studies to prove. Active stimulation improves pain and swelling in patients with arthritis of other joints, but this benefit does not show a significant improvement of pain relief for walking" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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