Astagraf Xl

Vitiligo, Pyoderma Gangrenosum, Kidney Transplantation + 12 more

Treatment

5 FDA approvals

20 Active Studies for Astagraf Xl

What is Astagraf Xl

Tacrolimus

The Generic name of this drug

Treatment Summary

Tacrolimus (also known as FK-506 or Fujimycin) is an immunosuppressive drug used to reduce the activity of the patient's immune system after an organ transplant. It is also used to treat severe atopic dermatitis, uveitis after bone marrow transplants, and vitiligo. Tacrolimus was discovered in 1984 from a Japanese soil sample and works by binding to FKBP-12, which prevents calcineurin from activating T-lymphocytes and IL-2 transcription.

Prograf

is the brand name

Astagraf Xl 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 Astagraf Xl Affects Patients

Tacrolimus works by blocking the activity of proteins that help activate the immune system. This helps decrease the risk of organ rejection and has also been shown to be effective for treating eczema. It doesn't work as powerfully as topical steroids, but it can be used directly on the face without causing thinning of the skin. On other parts of the body, topical steroids are usually a better choice.

How Astagraf Xl works in the body

The exact way tacrolimus works to treat atopic dermatitis is unknown, but there are some observed effects. Tacrolimus works by blocking an intracellular protein called FKBP-12, which prevents the formation of a complex that initiates gene transcription for making lymphokines. Tacrolimus also prevents the transcription of genes that produce inflammatory molecules like IL-3, IL-4, IL-5, GM-CSF, and TNF-. Additionally, tacrolimus can stop the release of pre-formed mediators from skin mast cells and basophils, as well as downregulating

When to interrupt dosage

The suggested measure of Astagraf Xl is contingent upon the diagnosed situation, including Vitiligo, Rejection; Transplant, Kidney and Pyoderma Gangrenosum. The amount fluctuates based on the method of delivery (e.g. Capsule, gelatin coated - Oral or Topical) outlined in the table beneath.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Warnings

Astagraf Xl has one contraindication, so it should be avoided when confronted with any of the conditions in the ensuing table.

Astagraf Xl 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 Astagraf Xl.

Common Astagraf Xl 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.

Astagraf Xl Toxicity & Overdose Risk

Taking too much of this drug can cause blurry vision, kidney and liver issues, seizures, trembling, high blood pressure, low magnesium levels, diabetes, high potassium levels, itching, difficulty sleeping, and confusion. The toxic dose in rats is 134-194mg/kg.

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

Astagraf Xl Novel Uses: Which Conditions Have a Clinical Trial Featuring Astagraf Xl?

147 active trials are currently being conducted to assess the potency of Astagraf Xl in providing relief for Oral Lichen Planus, Pyoderma Gangrenosum and refractory Rheumatoid arthritis.

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

24 Actively Recruiting

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

Dermatitis, Atopic

0 Actively Recruiting

Astagraf Xl Reviews: What are patients saying about Astagraf Xl?

5

Patient Review

4/28/2015

Astagraf Xl for Prevent Kidney Transplant Rejection

The side effects were really concerning me, but after doing some research I feel a lot better about taking the medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about astagraf xl

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

Can you crush extended-release tablets?

"There are some extended-release products that can be crushed or chewed, but the majority should not be. Apr 1, 2009"

Answered by AI

What is ASTAGRAF XL used for?

"ASTAGRAF XL is a prescription medicine that helps prevent organ rejection in people who have had a kidney transplant. ASTAGRAF XL is an extended-release capsule, and is not the same as tacrolimus immediate-release capsules, tacrolimus for oral suspension, or tacrolimus extended-release tablets."

Answered by AI

What happens if tacrolimus level is high?

"You should not take more or less of the medicine than your doctor ordered, and you should not take it more often than they said. If you use too much of the medicine, it will increase the chance for side effects. If you use too little, it may cause your transplanted organ to be rejected. The medicine comes with a Medication Guide or a patient information insert with patient instructions."

Answered by AI

What causes tacrolimus levels to rise?

"The pharmacokinetics of tacrolimus are influenced by many factors which can result in elevated concentrations, including genetic variability, acute infections, liver dysfunction, and interacting medications."

Answered by AI

Clinical Trials for Astagraf Xl

Image of Ohio State University Comprehensive Cancer Center in Columbus, United States.

Ruxolitinib for T-Cell Lymphoma

18+
All Sexes
Columbus, OH

This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The "graft" is the donor blood cells that patients get during the transplant. The "host" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.

Phase 2
Recruiting

Ohio State University Comprehensive Cancer Center

Jonathan Brammer, MD

Incyte Corporation

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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)

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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.

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