Arava

Rheumatoid Arthritis, Juvenile arthritis
Treatment
1 FDA approval
20 Active Studies for Arava

What is Arava

LeflunomideThe Generic name of this drug
Treatment SummaryLeflunomide 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.
Aravais 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 PatientsLeflunomide 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 bodyLeflunomide 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 RiskThe 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
55 Actively Recruiting
Not Applicable, Phase 4, Phase 3, Phase 2, Phase 1
Juvenile arthritis
8 Actively Recruiting
Phase 2, Not Applicable, Phase 3

Arava Reviews: What are patients saying about Arava?

5Patient Review
2/4/2015
Arava for Rheumatoid Arthritis
5Patient 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.
5Patient 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.
4.3Patient 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.
4.3Patient 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.
3.7Patient Review
10/30/2014
Arava for Rheumatoid Arthritis
3.3Patient Review
10/10/2016
Arava for Psoriasis associated with Arthritis
I experienced severe stomach pain and bloating after taking this medication.
3.3Patient 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.
3.3Patient 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.
3Patient 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.
3Patient 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.
2.3Patient 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.
1.7Patient Review
10/19/2017
Arava for Rheumatoid Arthritis
This is the second medication I've tried and it unfortunately didn't work either.
1Patient Review
3/21/2017
Arava for Rheumatoid Arthritis
Prolonged and significant hair loss.
1Patient 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
1Patient 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.
image of drug pills surrounding a glass of water symbolizing drug consumption

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 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 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
Have you considered Arava clinical trials? We made a collection of clinical trials featuring Arava, we think they might fit your search criteria.Go to Trials
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 & CEOTruway 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 MedicineHadas Nahman-Averbuch, PhD
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 DiseasesDaniel ZachsSecondWave Systems Inc.
Have you considered Arava clinical trials? We made a collection of clinical trials featuring Arava, we think they might fit your search criteria.Go to Trials
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
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 CentreBrent R Ohata, MD
Have you considered Arava clinical trials? We made a collection of clinical trials featuring Arava, we think they might fit your search criteria.Go to Trials
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