Protopic

Vitiligo, Pyoderma Gangrenosum, Kidney Transplantation + 12 more
Treatment
5 FDA approvals
20 Active Studies for Protopic

What is Protopic

TacrolimusThe Generic name of this drug
Treatment SummaryTacrolimus 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.
Prografis 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 Liver Transplant Rejection and Kidney Transplantation .
Liver Transplant Rejection
Kidney Transplantation
Kidney Transplant Rejection
Immunosuppressive Treatment
Kidney

Effectiveness

How Protopic Affects PatientsTacrolimus 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 bodyWe 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
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
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, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical

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 RiskTaking 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
54 Actively Recruiting
Not Applicable, Phase 4, Phase 3, Phase 2, Phase 1
Immunocompromised
3 Actively Recruiting
Not Applicable, Phase 1
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
24 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?

5Patient 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.
5Patient Review
9/1/2014
Protopic for Eczema Skin Condition Resisting Treatment
I haven't seen any benefits from using this medication.
5Patient 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.
5Patient 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.
4.3Patient 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!
4Patient 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.
3.3Patient 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.
3.3Patient 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.
2Patient 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??
2Patient 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.
1Patient 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

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. Our 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 We Think: We 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 We're Doing: We 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 we'll look at is how much better patients feel after 6 weeks, based on a questionnaire designed to measure RA flares. We'll 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: We've already surveyed University of Toronto rheumatologists who support the idea and provided input on study design. We've 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, we 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 California Clinical Trials Medical Group in Glendale, United States.

NTR-1011 for Lupus and Rheumatoid Arthritis

18 - 75
All Sexes
Glendale, CA
This phase 1a and 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of NTR-1011 in healthy adults and in adult patients with systemic lupus erythematosus and rheumatoid arthritis. The main goals of this study are to determine the safety profile of NTR-1011 across subcutaneous and intravenous dose levels, understand how the drug behaves in the body, characterize its biological activity through relevant pharmacodynamic markers, assess the potential for immune responses to treatment, and explore early signals of clinical benefit in autoimmune disease settings. This is a randomized, double blind, placebo controlled study that begins with a single ascending dose evaluation in healthy volunteers followed by a multiple dose assessment in patients. The design is intended to define the highest safe and well tolerated dose, establish a robust PK and PD baseline, and generate initial patient level evidence to support dose selection and advancement into subsequent clinical development.
Phase 1
Recruiting
California Clinical Trials Medical GroupHakop Gevorkyan, MDNeutrolis
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 CollegeIris Y Navarro-Millán, MDBristol-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)
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 DiseasesHubert LimSecondWave Systems Inc.
Image of St. Lawrence Health in Potsdam, United States.

Primary Care for Rheumatoid Arthritis

18+
All Sexes
Potsdam, NY
Rheumatoid arthritis (RA) is a complex autoimmune disease where the immune system attacks healthy joint tissue; causing pain, swelling, and stiffness of the joints. This disease effects lots of people in the US and can lead to major joint damage if not properly treated. In rural areas like northern NY, these are underserved areas for RA patients, thus many patients struggle to get the appropriate care. This model is testing whether primary care providers (PCP) can safely and effectively provide stable RA patients with the proper treatment rather than send them to a specialist. PCPs were trained through classes, case reviews, and a final exam. Patients will be randomly assigned to either see a trained PCP or their normal rheumatologist at the rheumatology clinic. This study will examine how patients are doing over a year using medical exams and patient feedback. If this model proves to be successful, it will make RA treatment easier and more affordable for patients.
Recruiting
Has No Placebo
St. Lawrence HealthEyal Kedar, MD
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Image of City of Hope Medical Center in Duarte, United States.

Emapalumab for Graft-versus-Host Disease

18 - 75
All Sexes
Duarte, CA
This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.
Phase 1
Waitlist Available
City of Hope Medical CenterAmandeep Salhotra
Image of Clinical Research Of West Florida - Phase I Unit /ID# 272428 in Clearwater, United States.

Targeted Therapies for Rheumatoid Arthritis

18+
All Sexes
Clearwater, FL
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Phase 2
Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 272428 (+31 Sites)ABBVIE INC.AbbVie
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