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
Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis
- First Posted Date
- 2008-01-16
- Last Posted Date
- 2010-10-13
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 124
- Registration Number
- NCT00596206
- Locations
- 🇷🇴
Sanofi-Aventis Administrative Office, Bucuresti, Romania
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Methotrexate-Sulfasalazine-HydroxychloroquineDrug: Leflunomide-Sulfasalazine-Hydroxychloroquine
- First Posted Date
- 2007-12-24
- Last Posted Date
- 2023-10-02
- Lead Sponsor
- University of Nebraska
- Target Recruit Count
- 69
- Registration Number
- NCT00579878
- Locations
- 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
Leflunomide + Methotrexate in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- First Posted Date
- 2007-11-26
- Last Posted Date
- 2007-12-05
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 74
- Registration Number
- NCT00563849
- Locations
- 🇰🇷
Sanofi-Aventis, Pusan, Korea, Republic of
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
- Conditions
- Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2007-05-22
- Last Posted Date
- 2019-08-12
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 836
- Registration Number
- NCT00476996
- Locations
- 🇺🇸
Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States
🇺🇸Center For Arthritis & Osteoporosis, Elizabethtown, Kentucky, United States
🇺🇸Arthritis Consultants, Saint Louis, Missouri, United States
Objective Study in Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- First Posted Date
- 2007-03-26
- Last Posted Date
- 2008-09-05
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 249
- Registration Number
- NCT00451971
- Locations
- 🇦🇺
Sanofi-Aventis, Sydney, Australia
Leflunomide in Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- First Posted Date
- 2006-01-23
- Last Posted Date
- 2011-01-11
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 60
- Registration Number
- NCT00280644
- Locations
- 🇹🇷
Sanofi-Aventis, Istanbul, Turkey
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
- Conditions
- Nephritis, Lupus
- First Posted Date
- 2005-12-22
- Last Posted Date
- 2005-12-22
- Lead Sponsor
- Peking University
- Registration Number
- NCT00268567
- Locations
- 🇨🇳
Renal Division, Peking University First Hospital, Beijing, China
🇨🇳Renal Division, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
🇨🇳Department of Rheumatology, the Second Affiliated Hospital, Harbin Medical University, Harbin, China
Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Procedure: PlasmapheresisProcedure: LeukapheresisProcedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)Procedure: Autologous CD34+HPC transplantation (HSCT)Drug: Growth colony stimulating factor (G-CSF)Drug: Corticosteroids
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸UCSD, Thornton Hospital, La Jolla, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
Effect of Leflunomide on T Cell Proliferation in HIV-Infected Patients
- Conditions
- HIV Infections
- First Posted Date
- 2005-01-10
- Last Posted Date
- 2017-07-02
- Target Recruit Count
- 41
- Registration Number
- NCT00101374
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse
- Conditions
- Brain and Central Nervous System Tumors
- First Posted Date
- 2004-09-14
- Last Posted Date
- 2012-09-13
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 60
- Registration Number
- NCT00003775
- Locations
- 🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Drug Development Updates
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