Leflunomide
- Generic Name
- Leflunomide
- Brand Names
- Arava, Leflunomide medac, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide ratiopharm
- Drug Type
- Small Molecule
- Chemical Formula
- C12H9F3N2O2
- CAS Number
- 75706-12-6
- Unique Ingredient Identifier
- G162GK9U4W
- Background
Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.
- Indication
For the management of the signs and symptoms of active rheumatoid arthritis (RA) to improve physical function and to slow the progression of structural damage associated with the disease. Has also been used for the prevention of acute and chronic rejection in recipients of solid organ trasnplants and is designated by the FDA as an orphan drug for this use.
- Associated Conditions
- Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis
To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: intravenous placeboDrug: subcutaneous placebo
- First Posted Date
- 2013-01-15
- Last Posted Date
- 2017-06-26
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 202
- Registration Number
- NCT01768572
- Locations
- 🇺🇸
Investigational Site Number 840033, Fort Lauderdale, Florida, United States
🇺🇸Investigational Site Number 840150, Lansing, Michigan, United States
🇺🇸Investigational Site Number 840022, Dallas, Texas, United States
The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
- First Posted Date
- 2012-11-15
- Last Posted Date
- 2022-04-14
- Lead Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Target Recruit Count
- 290
- Registration Number
- NCT01727193
- Locations
- 🇨🇳
The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY, Guangzhou, Guangdong, China
To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2012-10-18
- Last Posted Date
- 2017-08-08
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 546
- Registration Number
- NCT01709578
- Locations
- 🇺🇸
Investigational Site Number 840018, Idaho Falls, Idaho, United States
🇺🇸Investigational Site Number 840058, Columbia, South Carolina, United States
🇺🇸Investigational Site Number 840124, Clarksburg, West Virginia, United States
Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2012-08-07
- Last Posted Date
- 2014-12-02
- Lead Sponsor
- Singapore General Hospital
- Target Recruit Count
- 1
- Registration Number
- NCT01659242
- Locations
- 🇸🇬
Singapore General Hospital, Singapore, Singapore
An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria
- First Posted Date
- 2012-06-15
- Last Posted Date
- 2018-12-05
- Lead Sponsor
- Changzheng-Cinkate
- Target Recruit Count
- 24
- Registration Number
- NCT01620268
- Locations
- 🇺🇸
IU Health, Indianapolis, Indiana, United States
🇺🇸University of Lousiville, Louisville, Kentucky, United States
🇺🇸Beth Israel Deaconess Hospital, Boston, Massachusetts, United States
Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: non-steroidal anti-inflammatory drug (NSAID)Procedure: Acupuncture
- First Posted Date
- 2012-06-14
- Last Posted Date
- 2023-11-13
- Lead Sponsor
- Chinese Academy of Sciences
- Target Recruit Count
- 10
- Registration Number
- NCT01619176
- Locations
- 🇨🇳
Shanghai GuangHua Hospital of integrated traditional and western medicine, Shanghai, Shanghai, China
Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research
- First Posted Date
- 2012-06-12
- Last Posted Date
- 2012-06-14
- Lead Sponsor
- Shanxi Medical University
- Target Recruit Count
- 500
- Registration Number
- NCT01617590
- Locations
- 🇨🇳
rheumatism department,Second hospital of Shanxi medical university, TaiYuan, Shanxi, China
Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma
- First Posted Date
- 2012-06-05
- Last Posted Date
- 2017-04-06
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 3
- Registration Number
- NCT01611675
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
- Conditions
- Lupus Nephritis
- Interventions
- First Posted Date
- 2011-04-26
- Last Posted Date
- 2014-10-17
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 84
- Registration Number
- NCT01342016
A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2010-10-21
- Last Posted Date
- 2016-11-02
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 211
- Registration Number
- NCT01225393
Drug Development Updates
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