Protopic

Vitiligo, Pyoderma Gangrenosum, Kidney Transplantation + 12 more

Treatment

5 FDA approvals

20 Active Studies for Protopic

What is Protopic

Tacrolimus

The Generic name of this drug

Treatment Summary

Tacrolimus is a drug used to suppress the immune system in order to prevent organ rejection after transplant surgery. It can also be used to treat severe atopic dermatitis, a type of skin condition, and vitiligo, a condition where the skin loses its color. Tacrolimus works by binding to an immunophilin called FKBP-12, which switches off a protein called calcineurin and stops T-lymphocyte cells from sending signals that cause inflammation. Tacrolimus was discovered in 1984 from a Japanese soil sample containing the bacteria Streptomyces tsukubaensis.

Prograf

is the brand name

image of different drug pills on a surface

Protopic Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Prograf

Tacrolimus

1994

138

Approved as Treatment by the FDA

Tacrolimus, also called Prograf, is approved by the FDA for 5 uses such as Kidney Transplantation and Kidney Transplant Rejection .

Kidney Transplantation

Kidney Transplant Rejection

Liver Transplant Rejection

Immunosuppressive Treatment

Kidney

Effectiveness

How Protopic Affects Patients

Tacrolimus works by attaching to a protein called FKBP-12, which stops the body from sending signals that cause inflammation. It is similar to another drug called cyclosporine, but has been shown to be more effective in preventing rejection of transplanted organs. Tacrolimus is also used to treat eczema, especially atopic eczema, as it suppresses inflammation like steroids but is not as strong. In addition, tacrolimus can be used directly on the face while topical steroids should not be used there since they can thin the skin. For other parts of the body though, topical steroids

How Protopic works in the body

We don't know exactly how tacrolimus works to treat atopic dermatitis. But, it appears to prevent cells from creating proteins that cause inflammation. Tacrolimus binds to a protein inside cells and stops them from producing molecules like interleukin-3, interleukin-4, interleukin-5, GM-CSF, and TNF-, which are all related to inflammation. Tacrolimus also stops mast cells and basophils from releasing substances that cause inflammation and it reduces the expression of a protein on Langerhans cells that helps cause inflammation.

When to interrupt dosage

The prescribed dosage of Protopic is contingent upon the confirmed affliction, including Vitiligo, Rejection; Transplant, Kidney and Pyoderma Gangrenosum. The measure of dosage is contingent upon the technique of delivery (e.g. Capsule, gelatin coated - Oral or Topical) as observed in the table underneath.

Condition

Dosage

Administration

Liver

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Pyoderma Gangrenosum

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Dermatitis, Atopic

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Dermatitis, Atopic

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Rheumatoid Arthritis

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Lichen Planus, Oral

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Chronic Graft Versus Host Disease

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Lung

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Psoriasis

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Immunocompromised

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Vitiligo

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Kidney Transplantation

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Prophylaxis against heart transplant rejection

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Kidney

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Immunosuppressive Treatment

0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg

Oral, Capsule, , Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release - Oral, Tablet, extended release, Solution, Intravenous, Solution - Intravenous, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension - Oral, Granule, for suspension, Cream, Cream - Topical, Solution - Topical, Kit

Warnings

Protopic Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Tacrolimus may interact with Pulse Frequency

There are 20 known major drug interactions with Protopic.

Common Protopic Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Tacrolimus.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Tacrolimus.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Tacrolimus.

Axitinib

Major

The serum concentration of Axitinib can be increased when it is combined with Tacrolimus.

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Tacrolimus.

Protopic Toxicity & Overdose Risk

Taking too much of this drug can lead to blurred vision, liver and kidney damage, seizures, shaking, high blood pressure, low magnesium levels, diabetes, high potassium levels, itching, difficulty sleeping, and disorientation. The lowest toxic dose in rats has been found to be between 134 and 194 mg/kg.

image of a doctor in a lab doing drug, clinical research

Protopic Novel Uses: Which Conditions Have a Clinical Trial Featuring Protopic?

147 active trials are currently being conducted to assess the potential of Protopic for Oral Lichen Planus, Pyoderma Gangrenosum and refractory Rheumatoid Arthritis management.

Condition

Clinical Trials

Trial Phases

Pyoderma Gangrenosum

2 Actively Recruiting

Phase 2, Phase 3

Rheumatoid Arthritis

58 Actively Recruiting

Not Applicable, Phase 3, Phase 2, Phase 1, Phase 4

Immunocompromised

2 Actively Recruiting

Phase 1, Not Applicable

Lichen Planus, Oral

0 Actively Recruiting

Vitiligo

7 Actively Recruiting

Phase 2, Phase 3, Phase 1

Kidney Transplantation

0 Actively Recruiting

Kidney

0 Actively Recruiting

Liver

0 Actively Recruiting

Immunosuppressive Treatment

0 Actively Recruiting

Lung

0 Actively Recruiting

Dermatitis, Atopic

0 Actively Recruiting

Prophylaxis against heart transplant rejection

0 Actively Recruiting

Psoriasis

0 Actively Recruiting

Chronic Graft Versus Host Disease

22 Actively Recruiting

Phase 4, Phase 1, Phase 2, Not Applicable, Phase 3

Dermatitis, Atopic

0 Actively Recruiting

Protopic Reviews: What are patients saying about Protopic?

5

Patient Review

4/20/2015

Protopic for Eczema Skin Condition Resisting Treatment

I had mixed results with this medication. At first, it seemed to help my eyelids, but then I developed large sores on my lips. This is a serious side effect that you should be aware of before using the medication.

5

Patient Review

9/1/2014

Protopic for Eczema Skin Condition Resisting Treatment

I haven't seen any benefits from using this medication.

5

Patient Review

1/5/2016

Protopic for Eczema Skin Condition Resisting Treatment

So far, this has worked great for my psoriasis. I was instructed to use it every night until my skin clears up and then twice a week for maintenance. After just two uses, the itchiness, flakiness, and redness were gone. I'm looking forward to seeing how well it works in the long term.

5

Patient Review

8/20/2020

Protopic for Atopic Dermatitis

This is the only medication that has ever helped clear up my skin issue on my eyelids.

4.3

Patient Review

1/25/2016

Protopic for Atopic Dermatitis

I started developing eczema around my eyes when I was fourteen. After trying a few different products, this one finally gave me the relief I needed. It burns a little bit at first, but it's definitely worth it!

4

Patient Review

6/2/2015

Protopic for Eczema Skin Condition Resisting Treatment

I had eczema as a kid and it started flaring up again around my nose, mouth, and eyelids when I turned 30. I tried everything from lanolin ointment to steroid ointments without any relief for months. But after just three days of using this treatment (twice a day), my eczema was completely gone! It burns a little bit when you first put it on, but the results are more than worth it.

3.3

Patient Review

1/13/2015

Protopic for Atopic Dermatitis

We tried this treatment for my son's chronic eczema at the doctor's suggestion. While it looked like it was working at first, things quickly took a turn for the worse. He started getting headaches and sore throats, and also developed stomach aches and pains. We're stopping the medication now, and hopefully there won't be any lasting effects from such a short course of treatment.

3.3

Patient Review

7/22/2015

Protopic for Eczema Skin Condition Resisting Treatment

I get flare-ups on my eyelids, so bad that my eyes will almost completely swell shut. The first time I used it on my eyelids it burned and itched like fire. Gradually that went away (after a few hours) and after a day or so my the eczema was mostly gone.

2

Patient Review

11/27/2014

Protopic for Eczema Skin Condition Resisting Treatment

My teenage son uses this only on flare ups and it clears it after just a few days. I only use it once a day before bed and he hasn't had any side effects. I am afraid to use it on his face though, but some of your review state that it's ok??

2

Patient Review

9/30/2017

Protopic for Atopic Dermatitis

I've had eczema for over 30 years and have tried everything on the market. Protopic was the first thing that worked long-term, especially for my face. It can burn a little bit when you put it on, but that goes away after a few uses. This medication has been a lifesaver for me.

1

Patient Review

10/22/2022

Protopic for Eczema Skin Condition Resisting Treatment

Do not use this cream! I have had psoriasis for 14 years and recently tried this new cream. After only four days, I broke out in painful blisters that are spreading. It's behaving similarly to a second degree burn. Avoid at all costs.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about protopic

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is PROTOPIC Ointment used for?

"PROTOPIC Ointment is a prescription medicine used topically to treat eczema. It belongs to a class of medicines called topical calcineurin inhibitors and is for use in adults and children aged 2 years and older who do not have a weakened immune system."

Answered by AI

What are the side effects of Protopic?

"The side effects of this medication include a mild burning or stinging sensation, skin redness, acne, cold or flu symptoms (stuffy nose, sneezing, sore throat), headache, and increased sensitivity to hot or cold temperatures."

Answered by AI

Is Protopic safe for face?

"This ointment can be applied to any area of the body, except for mucous membranes, including the face, neck, and areas where the skin bends. It shouldn't be applied with an occlusive dressing because this method hasn't been studied in patients."

Answered by AI

Is Protopic a steroid cream?

"There are many treatments for eczema, but Protopic is different because it does not contain steroids. This means that it will not cause any of the side effects of topical steroids."

Answered by AI

Clinical Trials for Protopic

Have you considered Protopic clinical trials?

We made a collection of clinical trials featuring Protopic, we think they might fit your search criteria.
Go to Trials
Image of Sunnybrook Health Sciences Centre in Toronto, Canada.

Steroids for Rheumatoid Arthritis

18+
All Sexes
Toronto, Canada

People living with rheumatoid arthritis (RA) often experience flares-periods where their symptoms suddenly get worse. These flares can cause significant pain, make it harder to move and do daily activities, and lower overall quality of life. Doctors often treat flares with medications called glucocorticoids (GCs), which reduce inflammation. These medications can be taken by mouth (oral/PO) or given as a single injection into the muscle (intramuscular/IM). However, it's not clear which option works better from the patient's point of view-especially when it comes to relief of symptoms, improvements in function, and satisfaction with treatment. Most research so far has focused on how well the drugs control the disease, rather than how they impact the patient's overall experience. Research Questions: 1. Does a single GC injection work just as well as taking pills over a few weeks in improving symptoms reported by patients? 2. How do the two treatments compare in terms of symptom relief, ability to function, and patient satisfaction? 3. What do patients think and feel about using GCs to treat RA flares? What the Investigators Think: The investigators believe that a one-time GC injection is just as good as taking pills for a few weeks when it comes to managing RA flares. In fact, the injection might even be safer and preferred by patients. What the Investigators are Doing: The investigators will study 220 adults with RA who are currently having a flare (with at least 3 swollen and tender joints). These patients will be recruited from rheumatology clinics at the University of Toronto and must not have used GCs in the past month. They will be randomly assigned to receive either: A single injection (Methylprednisolone 120 mg), or Oral pills (Prednisone starting at 15 mg daily and tapering down over 3 weeks). The main thing the investigators will look at is how much better patients feel after 6 weeks, based on a questionnaire designed to measure RA flares. The investigators will also look at how well they function, how satisfied they are with the treatment, and whether they had any side effects. In addition, 20 patients (10 from each group) will be interviewed to understand their experiences and opinions about flare treatment in more detail. Why This Is Possible: The investigators have already surveyed University of Toronto rheumatologists who support the idea and provided input on study design. The investigators have also partnered with experts in research methods, national arthritis organizations, and patient groups to make sure the study is relevant and meaningful. Ethics approval has been obtained. Why It Matters: RA flares can have a major impact on people's lives. While current treatments help control inflammation, the investigators need to better understand how these treatments affect people from their own perspective. This study will shift the focus to what matters most to patients, helping doctors and patients choose the best treatment based not only on medical results but also on the patient's experience. This could lead to more effective and personalized care for people living with RA.

Phase 4
Waitlist Available

Sunnybrook Health Sciences Centre (+4 Sites)

Image of Weill Cornell Medical College in New York, United States.

Health Coaching for Rheumatoid Arthritis

18+
All Sexes
New York, NY

The goal of this clinical trial is to learn if peer coaching works to reduce levels of anxiety and/or depression in adults diagnosed with Rheumatoid Arthritis (RA). The main questions it aims to answer are: Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months from baseline? Do people with RA who complete the intervention with a peer coach have lower levels of anxiety and/or depression at 6 months compared to those in the control arm? Researchers will compare the peer coaching intervention to an active-control arm (where people without RA coach participants on general health and nutrition topics) to see if peer coaching works to reduce anxiety and/or depression. Participants will meet with a coach every week for 9 weeks and complete several surveys before, during and after the intervention

Recruiting
Has No Placebo

Weill Cornell Medical College

Iris Y Navarro-Millán, MD

Bristol-Myers Squibb

Image of Humana Healthcare Research, Inc. in Louisville, United States.

Academic Detailing for Rheumatoid Arthritis

Any Age
All Sexes
Louisville, KY

The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are: 1. Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab? 2. Do in-person or virtual visits work better? Researchers will compare clinicians offered the educational outreach visit to those who are not offered the visit to see if there is a difference in prescribing of biosimilar versions of adalimumab instead of the original brand-name version. Participants will be offered the chance to meet with a trained clinician who will provide educational information tailored to their knowledge and attitudes on the topic. They will also be provided an educational brochure and patient educational materials.

Waitlist Available
Has No Placebo

Humana Healthcare Research, Inc. (+1 Sites)

Image of Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016) in New York, United States.

Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

The ImmuneNet study is a Phase I/II clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this "quantum-synaptic" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis. Participants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells. A machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy. The expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.

Phase 1 & 2
Waitlist Available

Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)

Gavin Solomon, President & CEO

Truway Health, Inc.

Have you considered Protopic clinical trials?

We made a collection of clinical trials featuring Protopic, we think they might fit your search criteria.
Go to Trials
Image of University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases in Minneapolis, United States.

Ultrasound Therapy for Rheumatoid Arthritis

18+
All Sexes
Minneapolis, MN

The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.

Recruiting
Drug

University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases (+4 Sites)

Daniel Zachs

SecondWave Systems Inc.

Have you considered Protopic clinical trials?

We made a collection of clinical trials featuring Protopic, we think they might fit your search criteria.
Go to Trials