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
- Associated Therapies
- -
Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2015-07-27
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 12
- Registration Number
- NCT02509052
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA
- Conditions
- Interventions
- Other: Lab WorkDrug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg)Drug: Certolizumab pegol (CDP870, tradename Cimzia)Drug: HydroxychloroquineDrug: SulfasalazineDrug: MedrolDrug: PrednisoneDrug: TriamcinoloneDrug: NaproxenDrug: LeflunomideDrug: MethotrexateDrug: humira
- First Posted Date
- 2015-05-22
- Last Posted Date
- 2024-07-10
- Lead Sponsor
- University of Illinois at Chicago
- Target Recruit Count
- 32
- Registration Number
- NCT02451748
- Locations
- 🇺🇸
Outpatient Care Center, Chicago, Illinois, United States
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
- Conditions
- Interventions
- First Posted Date
- 2015-02-26
- Last Posted Date
- 2018-01-30
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 91
- Registration Number
- NCT02373202
- Locations
- 🇯🇵
Investigational Site Number 392039, Fukuoka-Shi, Japan
🇯🇵Investigational Site Number 392006, Sasebo-Shi, Japan
🇯🇵Investigational Site Number 392023, Takaoka-Shi, Japan
Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
- Conditions
- Interventions
- First Posted Date
- 2014-10-27
- Last Posted Date
- 2014-10-27
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Target Recruit Count
- 240
- Registration Number
- NCT02275299
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
- First Posted Date
- 2014-02-07
- Last Posted Date
- 2017-06-20
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 217
- Registration Number
- NCT02057250
- Locations
- 🇨🇱
Investigational Site Number 152050, Santiago, Chile
🇨🇱Investigational Site Number 152007, Viña Del Mar, Chile
🇲🇽Investigational Site Number 484005, Monterrey, Mexico
Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis
- First Posted Date
- 2013-12-31
- Last Posted Date
- 2013-12-31
- Lead Sponsor
- Mashhad University of Medical Sciences
- Target Recruit Count
- 30
- Registration Number
- NCT02024334
A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis
- Conditions
- Interventions
- First Posted Date
- 2013-09-13
- Last Posted Date
- 2018-11-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 100
- Registration Number
- NCT01941095
- Locations
- 🇬🇷
Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens, Greece
🇬🇷Uni Hospital of Ioannina; Rheumatology, Ioannina, Greece
🇬🇷General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine, Thessaloniki, Greece
A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome
- Conditions
- Interventions
- First Posted Date
- 2013-01-24
- Last Posted Date
- 2014-12-19
- Target Recruit Count
- 304
- Registration Number
- NCT01774877
- Locations
- 🇨🇳
The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China
🇨🇳Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
🇨🇳The first affiliated hospital of anhui medical university, Hefei, Anhui, China
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)
- 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
- Target Recruit Count
- 290
- Registration Number
- NCT01727193
- Locations
- 🇨🇳
The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY, Guangzhou, Guangdong, China
Drug Development Updates
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