Astagraf Xl

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

What is Astagraf Xl

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

Effectiveness

How Astagraf Xl Affects PatientsTacrolimus 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 bodyThe 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
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
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
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

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 RiskTaking 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
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

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

5Patient 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 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 Astagraf Xl clinical trials? We made a collection of clinical trials featuring Astagraf Xl, 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
Have you considered Astagraf Xl clinical trials? We made a collection of clinical trials featuring Astagraf Xl, we think they might fit your search criteria.Go to Trials
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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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