Arava

Rheumatoid Arthritis, Juvenile arthritis

Treatment

1 FDA approval

20 Active Studies for Arava

What is Arava

Leflunomide

The Generic name of this drug

Treatment Summary

Leflunomide is a drug that belongs to a class called DMARDs (disease-modifying antirheumatic drugs). It was approved by the FDA and other countries in 1999 and is used to inhibit the production of pyrimidine, a type of nucleic acid.

Arava

is the brand name

image of different drug pills on a surface

Arava 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 Arava Affects Patients

Leflunomide is a medicine used to treat adults with rheumatoid arthritis, an autoimmune disease that involves too much activity from T cells. T cells need pyrimidines to work, and they get this from two pathways: the salvage pathways and the de novo synthesis. The de novo pathway is the one the T cells use when they are working extra hard. Leflunomide works by blocking dihydroorotate dehydrogenase, which prevents T cells from getting the pyrimidines they need, thus reducing their activity.

How Arava works in the body

Leflunomide works by blocking the growth of autoimmune lymphocytes. It does this by interfering with the cell cycle process, which is how cells reproduce. Specifically, it stops an enzyme called dihydroorotate dehydrogenase from creating molecules needed for DNA and RNA synthesis. Without these molecules, the cells cannot reproduce. Additionally, leflunomide also blocks tyrosine kinases, which are enzymes involved in DNA repair and cell proliferation. By blocking these enzymes, it helps to prevent the repair of tumor cells.

When to interrupt dosage

The advised dosage of Arava is contingent upon the identified condition. The amount of dosage fluctuates, depending on the technique of administration specified in the table beneath.

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

Arava Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

Severe Hepatic Impairment

Do Not Combine

There are 20 known major drug interactions with Arava.

Common Arava 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.

Arava Toxicity & Overdose Risk

The lethal dose of this drug is between 100-250mg/kg when taken orally.

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

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

At present, 86 active clinical trials are examining the potential of Arava to provide relief from Rheumatoid Arthritis.

Condition

Clinical Trials

Trial Phases

Rheumatoid Arthritis

63 Actively Recruiting

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

Juvenile arthritis

7 Actively Recruiting

Phase 2, Not Applicable, Phase 3

Arava Reviews: What are patients saying about Arava?

5

Patient Review

2/4/2015

Arava for Rheumatoid Arthritis

5

Patient Review

8/6/2015

Arava for Rheumatoid Arthritis

Arava did help me with the inflammation in my veins, but only for a short while. It also seems to be causing hair loss, which is a pretty big downside.

5

Patient Review

4/21/2016

Arava for Rheumatoid Arthritis

I've been taking this for ten years and it's really helped me. I increased the dosage to 40mg on weekends to help with my temporal arteritis symptoms, and that's been working well for eight months now.

4.3

Patient Review

7/28/2017

Arava for Rheumatoid Arthritis

There are no negative side effects that I have experienced from this medication, and I've been taking it for years.

4.3

Patient Review

5/15/2019

Arava for Rheumatoid Arthritis

I was on Arava for around six to seven weeks and noticed a drastic reduction in pain. However, within the last week my blood pressure and pulse rate increased significantly. I stopped taking the medication but would love to know if this is a common side effect and how long it takes for blood pressure to normalize.

3.7

Patient Review

10/30/2014

Arava for Rheumatoid Arthritis

3.3

Patient Review

10/10/2016

Arava for Psoriasis associated with Arthritis

I experienced severe stomach pain and bloating after taking this medication.

3.3

Patient Review

10/13/2015

Arava for Rheumatoid Arthritis

I had to stop taking Arava, Meloxicam, and Plaquenil. I'm not sure which one was causing the side effects, but I haven't been able to keep food down for days and my liver count has gone up tremendously.

3.3

Patient Review

7/28/2017

Arava for Rheumatoid Arthritis

I take this every morning, and unfortunately it leaves me feeling nauseous for at least half the day. However, I don't have any other options until after my next surgery.

3

Patient Review

3/22/2015

Arava for Rheumatoid Arthritis

I took Arava for a few years and it was pretty effective, except my potassium levels would go up and down, which then led to issues with blood pressure and mood swings. I'm done with medication now and will just try natural methods like cherry juice or staying active.

3

Patient Review

2/16/2016

Arava for Rheumatoid Arthritis

I started Arava 4 months ago to help with my Mothotrexate treatment. However, I've lost almost 10lbs and am always tired. I don't think it's because I'm eating less, and the constant diarrhea isn't helping either. It's also very expensive, so I'll be telling my doctor that I want to stop taking it.

2.3

Patient Review

5/13/2015

Arava for Rheumatoid Arthritis

Arava completely removed the pain and stiffness I was experiencing. However, my blood pressure is now higher than it was before.

1.7

Patient Review

10/19/2017

Arava for Rheumatoid Arthritis

This is the second medication I've tried and it unfortunately didn't work either.

1

Patient Review

3/21/2017

Arava for Rheumatoid Arthritis

Prolonged and significant hair loss.

1

Patient Review

11/28/2018

Arava for Rheumatoid Arthritis

I have sjogrens and ra. The med given me the worst smelling gas and feces ever. My stomach is in constant pain or diahrea or nausea. Even w prednisone 5-10 mg never hungry making taking meds worse. Also on plaquinel for sjogrens. Not helping w pain only 5 weeks in but ready to throw in the towel

1

Patient Review

8/28/2016

Arava for Rheumatoid Arthritis

I've been taking Arava for five years now, and it's helped a lot. I was originally on 10mg daily, then increased to 20mg when that didn't seem to be working well enough. Recently, I had to reduce my dosage to 3 days a week because it started affecting my white blood cell count.
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Patient Q&A Section about arava

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

Which is safer methotrexate or leflunomide?

"Patients who took leflunomide were more likely than those who took methotrexate to discontinue treatment, but not because of adverse events.There was no significant difference between the leflunomide and methotrexate groups in the likelihood of elevated hepatic transaminase levels or weight loss."

Answered by AI

What is the drug Arava used for?

"Leflunomide belongs to another class of drugs called pyrimidine synthesis inhibitors.

Leflunomide (Arava) is a drug that is approved to treat adult moderate to severe rheumatoid arthritis as well as other rheumatic diseases. It is in a class of medications called disease-modifying antirheumatic drugs (DMARDs), which goal is to decrease inflammation and permanent damage. Leflunomide belongs to another class of drugs that are called pyrimidine synthesis inhibitors."

Answered by AI

What are the side effects of Arava?

"The side effects of the drug include, but are not limited to, back pain, dizziness, headache, itching, pain in the abdomen, problems with digestion, such as diarrhea, nausea, and vomiting, indigestion, skin rash, and swelling of the lining inside your nose, which can cause cold-like symptoms, such as a runny nose and sneezing."

Answered by AI

Does Arava cause weight gain?

"A 2016 study showed that people taking leflunomide (Arava), a disease-modifying antirheumatic drug, were more likely to experience weight loss. This may be because the drug can cause gastrointestinal side effects such as diarrhea, nausea, and an upset stomach."

Answered by AI

Clinical Trials for Arava

Image of Northwestern Medicine Rheumatology in Chicago, United States.

Patient-Reported Outcomes Dashboard for Inflammatory Arthritis

18+
All Sexes
Chicago, IL

The goal of this clinical trial is to learn whether showing patient-reported symptoms and personal treatment goals to rheumatology clinicians on a dashboard in the electronic health record improves shared decision-making for adults with rheumatoid arthritis or psoriatic arthritis. The main questions it aims to answer are: * Do patients whose clinicians use the dashboard report more shared decision-making during their rheumatology visits than patients who receive usual care? * Do patients in the dashboard group report greater progress toward their personal goals and more confidence in managing their symptoms after 6 months? Researchers will compare the dashboard group to a usual care group to see if the dashboard improves shared decision-making, goal attainment, and self-efficacy. Participants will: * Complete a routine symptom questionnaire before their rheumatology visits, as all clinic patients do * Choose personal treatment goals and rate their progress toward those goals 6 months later * Complete short surveys before and after two rheumatology visits about 6 months apart Participants in the dashboard group will also complete questionnaires in the patient portal about pain, fatigue, physical function, sleep, and morning stiffness before each visit. Their answers and goals will be shown to their clinician on a dashboard to guide the conversation during the visit.

Waitlist Available
Has No Placebo

Northwestern Medicine Rheumatology

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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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