Leflunomide

Rheumatoid Arthritis, Juvenile arthritis

Treatment

1 FDA approval

20 Active Studies for Leflunomide

What is Leflunomide

Leflunomide

The Generic name of this drug

Treatment Summary

Leflunomide is a medication used to treat certain inflammatory conditions. It belongs to a group of drugs called DMARDs (disease-modifying antirheumatic drugs). Leflunomide was approved by the FDA and Health Canada in 1999 and is available in many other countries in Europe.

Arava

is the brand name

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Leflunomide Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Arava

Leflunomide

1998

55

Approved as Treatment by the FDA

Leflunomide, also called Arava, is approved by the FDA for 1 uses including Rheumatoid Arthritis .

Rheumatoid Arthritis

Helps manage Rheumatoid Arthritis

Effectiveness

How Leflunomide Affects Patients

Leflunomide is a drug used to treat active rheumatoid arthritis in adults. Rheumatoid arthritis is an autoimmune disease which causes T-cells to be more active. T cells normally get their metabolic needs from a process called the salvage pathways. However, when T cells become activated, they require more pyrimidines than the salvage pathway can provide, so they need to use a different process called the de novo pathway for pyrimidine synthesis. Leflunomide works by stopping the de novo pathway for pyrimidine synthesis, which will affect activated T cells more than other cell types

How Leflunomide works in the body

Leflunomide works by targeting cell cycle progression and tyrosine kinases in autoimmune cells. It stops an enzyme called dihydroorotate dehydrogenase from forming, which prevents the production of a molecule used for making DNA and RNA. This stops the cell from dividing, and also interferes with how activated lymphocytes attach to the synovial vascular endothelial cells. It also prevents tyrosine kinases from activating pathways leading to DNA repair, which can help to treat cancer.

When to interrupt dosage

The proposed dosage of Leflunomide is contingent upon the diagnosed condition. The measure of dosage likewise differentiates, in line with the administration procedure featured in the table below.

Condition

Dosage

Administration

Rheumatoid Arthritis

, 10.0 mg, 20.0 mg, 100.0 mg, 15.0 mg

Tablet, film coated, Tablet, film coated - Oral, Oral, , Tablet, Tablet - Oral

Juvenile arthritis

, 10.0 mg, 20.0 mg, 100.0 mg, 15.0 mg

Tablet, film coated, Tablet, film coated - Oral, Oral, , Tablet, Tablet - Oral

Warnings

Leflunomide has two contraventions. It should not be utilized in combination with the conditions listed in the table below.

Leflunomide Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Severe Hepatic Impairment

Do Not Combine

There are 20 known major drug interactions with Leflunomide.

Common Leflunomide Drug Interactions

Drug Name

Risk Level

Description

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 Leflunomide.

Cabozantinib

Major

The metabolism of Cabozantinib can be decreased when combined with Leflunomide.

Cyclosporine

Major

Leflunomide may increase the immunosuppressive activities of Cyclosporine.

Dacomitinib

Major

The metabolism of Dacomitinib can be decreased when combined with Leflunomide.

Dicoumarol

Major

The metabolism of Dicoumarol can be decreased when combined with Leflunomide.

Leflunomide Toxicity & Overdose Risk

The highest dose of this drug that is considered safe has been found to be between 100-250 mg/kg.

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

Currently, 86 clinical trials are underway to assess the potential of Leflunomide to ameliorate Rheumatoid Arthritis.

Condition

Clinical Trials

Trial Phases

Rheumatoid Arthritis

56 Actively Recruiting

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

Juvenile arthritis

6 Actively Recruiting

Phase 2, Not Applicable, Phase 3

Leflunomide Reviews: What are patients saying about Leflunomide?

5

Patient Review

12/9/2014

Leflunomide for Rheumatoid Arthritis

This medication finally provided me with the relief I had been seeking. Love it!

4.7

Patient Review

4/3/2016

Leflunomide for Rheumatoid Arthritis

This provided excellent relief from my joint pain. However, I developed a really itchy rash on my back. Going to call the doctor tomorrow.

4.3

Patient Review

7/7/2016

Leflunomide for Rheumatoid Arthritis

I have found that this medication helps my joints a lot, however I am not sure if it is the cause of the ulcers in my mouth and side of mouth cracks. When I stop taking leflunomide, my mouth gets better, so I think there is a correlation.

4.3

Patient Review

8/5/2014

Leflunomide for Rheumatoid Arthritis

Leflunomide was great for decreasing the pain of RA. However, I began having serious breathing problems and had to stop taking it immediately.

4

Patient Review

10/20/2017

Leflunomide for Rheumatoid Arthritis

Since December 2016, I've been on 20mg of this medication. It's helped a lot, though my knees still ache some (but not enough to warrant pain relief). I do sometimes feel spacey, but that could be due to other factors. My blood pressure has stayed in a normal range while taking this drug.

4

Patient Review

1/26/2017

Leflunomide for Rheumatoid Arthritis

I was feeling pretty discouraged after reading some of the other reviews, but I decided to give this treatment a try anyway. So far, I'm really glad that I did! I've only been taking leflunomide for a short while now, but I already feel like the pain is lessening. From what I understand, it can take several weeks for the full effect to kick in, so fingers crossed that things continue to improve. The only downside thus far is that I sometimes feel a bit spacey and out of it.

3.7

Patient Review

8/5/2014

Leflunomide for Rheumatoid Arthritis

It's difficult to say how much this medication helped because several changes were made at the same time.

3.7

Patient Review

7/12/2017

Leflunomide for Rheumatoid Arthritis

I've been taking the 10 mg dosage and have felt a bit dizzy, though I'm getting used to it. My blood pressure has also been lower than normal (90/60), but is now back up to a more healthy level (110/70).

3

Patient Review

8/20/2014

Leflunomide for Rheumatoid Arthritis

Unfortunately, I had an adverse reaction to MTX, so I've been taking Leflunomide for the past 12 weeks. In addition to the 10mg/day dosage of that, I also take 10mg Prednisone. Some of the daily side effects I experience are loose stools, hair loss, rapid heart beat and chest pain, buttock and hamstring muscle pain. None of these have been alleviated by the medication change thus far and I'm still experiencing severe RA joint swelling and pain.

3

Patient Review

10/12/2020

Leflunomide for Rheumatoid Arthritis

I had some gastrointestinal issues while taking this medicine, as well as hair loss. I will be asking my doctor to take me off of it soon. I didn't like how it made me feel numb.

2.3

Patient Review

10/22/2016

Leflunomide for Rheumatoid Arthritis

I tried this medication, but I didn't feel like it was effective. I also tried IV therapy, which seemed to work better for me.

1

Patient Review

6/17/2016

Leflunomide for Rheumatoid Arthritis

I was on this drug for six weeks while also taking prednisone. Once I stopped taking the prednisone as instructed, my muscle pain and swelling got worse.

1

Patient Review

9/3/2021

Leflunomide for Rheumatoid Arthritis

I developed a horrible rash of blisters and redness after only 30 days. I'm now on my third round of Prednisone, and it's barely helping. My feet are so sore I can't walk, and my hands and shoulder are in constant pain.

1

Patient Review

11/20/2019

Leflunomide for Rheumatoid Arthritis

I was on this medication for approximately twelve months when I started to experience numbness in all of my toes. Now, I have permanent nerve damage as a result.
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Patient Q&A Section about leflunomide

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

Is leflunomide a strong drug?

"Leflunomide is an effective DMARD that can cause serious liver, blood, lung, and skin problems. It is also a potent immunosuppressant, which can make infections more severe."

Answered by AI

What are the side effects of taking leflunomide?

"If you experience any of the following symptoms, please seek medical attention: bloody or cloudy urine, difficult or painful urination, frequent urge to urinate, nausea or vomiting, yellow eyes or skin."

Answered by AI

What kind of drug is leflunomide?

"Leflunomide is a drug used to treat moderate to severe rheumatoid arthritis in adults, as well as other rheumatic diseases. It is classified as a disease-modifying antirheumatic drug (DMARD), which means it is designed to reduce inflammation and prevent permanent damage."

Answered by AI

What is leflunomide prescribed for?

"Leflunomide is a medication used to treat rheumatoid arthritis, either on its own or in combination with other medications. It is classed as a disease-modifying antirheumatic drug (DMARD)."

Answered by AI

Clinical Trials for Leflunomide

Image of University of Oklahoma Health Campus in Oklahoma City, United States.

Disulfiram for Rheumatoid Arthritis

18 - 75
All Sexes
Oklahoma City, OK

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent joint inflammation and systemic immune activation. Obesity is common among individuals with RA and is associated with increased disease activity, reduced treatment response, and worse functional outcomes. Inflammation in adipose tissue, driven in part by activation of the NLRP3 inflammasome and downstream gasdermin D (GSDMD)-mediated pathways, may contribute to systemic inflammation and RA disease severity. Disulfiram (DSF), an FDA-approved medication for alcohol use disorder, has recently been identified as an inhibitor of GSDMD-mediated inflammatory signaling and pyroptosis. Preclinical studies suggest that DSF reduces inflammasome activation, inflammatory cytokine release, and metabolic dysfunction. This study is a 12-week, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the safety, tolerability, and preliminary efficacy of DSF in overweight and obese adults with active RA despite stable disease-modifying antirheumatic drug (DMARD) therapy. Participants will be randomized to receive either DSF (250 mg daily) or placebo. The primary objective is to assess safety and tolerability. Secondary and exploratory objectives include evaluating the effects of DSF on systemic inflammation, RA disease activity, metabolic parameters, and adipose tissue inflammasome activation. Findings from this study will inform the feasibility and design of larger clinical trials targeting GSDMD-mediated inflammation in RA.

Phase 2
Waitlist Available

University of Oklahoma Health Campus

Beatriz Y Hanaoka, MD, MSc

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Nurse-led Telehealth for Rheumatoid Arthritis

18+
All Sexes
Montreal, Canada

Canada urgently needs new ways to provide rheumatology care that improve treatment and make it easier for people to get high-quality care. E-health technology is a new and promising way to do this, but it hasn't been studied much yet in rheumatology. The investigators will test a new way to help people with rheumatoid arthritis at four clinics in Quebec. This study will check if the new approach is easy to use, fits well into the clinics' daily routine, and if both patients and healthcare workers find it helpful and acceptable. This new approach involves nurses helping patients check their own health from home using an online platform. 104 adults who have rheumatoid arthritis and who have had a flare-up or a change in their medication in the last three months, will participate. Some will start using the online self-monitoring tool right away for 16 months, while others will continue with their usual care for 8 months before trying the tool. During the time they use the tool, they will fill out monthly online questionnaires to check their health. A rheumatology nurse will review their answers, suggest any needed care, provide personalized health information, and be available to answer questions through messages. This new way of care, where nurses help patients monitor their rheumatoid arthritis from home, helps make better use of limited specialist time. It's more convenient for patients, especially those who live far away, and helps meet their needs between regular doctor visits while keeping the quality of care high.

Waitlist Available
Has No Placebo

Hopital general de Montreal (+3 Sites)

Laetitia Michou, MD PhD

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Ketogenic and Carnivore Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis

18 - 64
All Sexes
Charlottesville, VA

This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \[ulcerative colitis and Crohn's disease\] (IBD) or rheumatoid arthritis (RA). Participants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control. Participants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation. Participants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.

Recruiting
Has No Placebo

Resilient Roots: Functional Medicine

Robert D Abbott, MD

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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
Recruiting

Sunnybrook Health Sciences Centre (+4 Sites)

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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

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Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

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

Phase 1 & 2
Waitlist Available

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

Gavin Solomon, President & CEO

Truway Health, Inc.

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Pain Mechanisms for Juvenile Arthritis

9 - 17
All Sexes
St Louis, MO

Juvenile idiopathic arthritis (JIA) is the most common rheumatologic disease in children. The main symptoms of JIA, which are often the primary focus of treatment, include joint swelling, stiffness, and tenderness. Additional symptoms can include malaise, fatigue, and pain. However, the exact mechanisms contributing to pain are not yet fully understood. Participants will complete a 2.5-hours study session. In the study session, psychophysical assessments of thermal and pressure stimuli will be performed. In addition, demographic, social, pubertal maturation, and behavioral and psychological factors will be collected via questionnaires. A saliva sample and/or blood draw may occur for the analysis of various immune factors and sex hormones. If a joint aspiration is done as part of their standard of care, we will request a sample of the synovial fluid for analyses of immune, hormonal and/or genetic factors. Participants will have the option to participate in additional optional follow-up study visits (every 3 months, up to 1 year) and to complete monthly surveys asking about their juvenile arthritis.

Recruiting
Has No Placebo

Washington University School of Medicine

Hadas Nahman-Averbuch, PhD

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