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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 for Maintenance of Remission in IgG4 Related Disease

Phase 4
Completed
Conditions
Immunoglobulin G4 Related Sclerosing Disease
Interventions
First Posted Date
2016-03-09
Last Posted Date
2019-03-06
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
68
Registration Number
NCT02703194
Locations
🇨🇳

Chinese PLA General Hospital, Beijing, China

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

First Posted Date
2015-12-31
Last Posted Date
2019-10-01
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Target Recruit Count
186
Registration Number
NCT02644499
Locations
🇮🇳

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, Pondicherry UT, India

Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1
Completed
Conditions
Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
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

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)

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

and more 37 locations

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Phase 4
Conditions
Rheumatoid Arthritis
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

Phase 3
Completed
Conditions
RA
Interventions
Device: Auto-Injector Device (AID)
Device: Pre-filled Syringe (PFS)
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

and more 50 locations

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Phase 4
Conditions
Juvenile Idiopathic Arthritis
Interventions
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

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

and more 7 locations

A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

Not Applicable
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Xinfeng capsule
First Posted Date
2013-01-24
Last Posted Date
2014-12-19
Lead Sponsor
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
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

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