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

image of different drug pills on a surface

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.

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

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 4, Phase 3, Phase 2, Phase 1

Juvenile arthritis

8 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.
image of drug pills surrounding a glass of water symbolizing drug consumption

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 Sunnybrook Health Sciences Centre in Toronto, Canada.

Steroids for Rheumatoid Arthritis

18+
All Sexes
Toronto, Canada

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

Phase 4
Waitlist Available

Sunnybrook Health Sciences Centre (+4 Sites)

Image of 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 Group

Hakop Gevorkyan, MD

Neutrolis

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

Academic Detailing for Rheumatoid Arthritis

Any Age
All Sexes
Louisville, KY

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

Waitlist Available
Has No Placebo

Humana Healthcare Research, Inc. (+1 Sites)

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

Electromagnetic Resonance Therapy for Autoimmune Diseases

Any Age
All Sexes
New York, NY

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

Phase 1 & 2
Waitlist Available

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

Gavin Solomon, President & CEO

Truway Health, Inc.

Image of Washington University School of Medicine in St Louis, United States.

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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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 Health

Eyal Kedar, MD

Image of Pender Community Health Centre in Vancouver, Canada.

Personalized Outreach for Rheumatic Diseases

18+
All Sexes
Vancouver, Canada

The primary goal of this study is to determine whether providing patient honoraria and/or outreach services can improve the attendance rate of appointments at an inner city rheumatology clinic in Vancouver, British Columbia. The main question it aims to answer are: * Does providing a financial honorarium ($20 for each follow-up appointment with completed bloodwork) improve attendance rate at an inner city rheumatology clinic? * Does providing a personalized outreach service for rheumatic diseases improve attendance rate at an inner city rheumatology clinic? The researchers will compare providing patient honoraria to providing both honoraria and outreach services, and compare each of these to the regular appointment schedule without honoraria or outreach. Participants will: * Undergo randomization to receive honoraria or honoraria and outreach services together * Complete surveys about their health and understanding of their rheumatic disease at baseline, 3-month, and 6-month intervals * Visit the clinic every month for check-ups and monitoring bloodwork if they are started on immunosuppressants for their condition

Waitlist Available
Has No Placebo

Pender Community Health Centre

Brent R Ohata, MD

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