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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

The Registry Study of Takayasu Arteritis in East China

Recruiting
Conditions
Takayasu Arteritis
Treatment Refusal
Outcome
Mechanisms, Defense
Pregnancy Related
Interventions
Biological: Tocilizumab
First Posted Date
2019-03-28
Last Posted Date
2021-08-10
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
1000
Registration Number
NCT03893136
Locations
🇨🇳

Department of Rheumatology in Zhongshan hospital, Fudan University, Shanghai, Shanghai, China

Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

First Posted Date
2019-01-09
Last Posted Date
2021-05-10
Lead Sponsor
University of Oxford
Target Recruit Count
1
Registration Number
NCT03797872
Locations
🇬🇧

Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

Phase 4
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2018-11-14
Last Posted Date
2025-01-24
Lead Sponsor
University of Oxford
Target Recruit Count
206
Registration Number
NCT03739853
Locations
🇬🇧

Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom

Leflunomide in Previously Treated Metastatic Triple Negative Cancers

Phase 1
Recruiting
Conditions
Breast Neoplasms
Breast Diseases
Metastatic Triple Negative Breast Cancer
Interventions
First Posted Date
2018-10-17
Last Posted Date
2024-05-30
Lead Sponsor
Joseph Sparano
Target Recruit Count
54
Registration Number
NCT03709446
Locations
🇺🇸

Mt Sinai Chelesa, New York, New York, United States

🇺🇸

Mt Sinai West, New York, New York, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA

Phase 4
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2018-08-28
Last Posted Date
2022-07-06
Lead Sponsor
P. Verschueren
Target Recruit Count
284
Registration Number
NCT03649061
Locations
🇧🇪

UZ Leuven, Leuven, Vlaams Brabant, Belgium

🇧🇪

CHU Liège, Liège, Belgium

🇧🇪

CHU Saint Pierre, Brussel, Belgium

and more 16 locations

Treatment With Leflunomide in Patients With Polymyalgia Rheumatica

Phase 3
Conditions
Polymyalgia Rheumatica
Interventions
First Posted Date
2018-07-03
Last Posted Date
2019-06-03
Lead Sponsor
Elisabeth Brouwer
Target Recruit Count
94
Registration Number
NCT03576794
Locations
🇳🇱

ZGT Almelo, Almelo, Netherlands

🇳🇱

University Medical Center Groningen, Groningen, Netherlands

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

First Posted Date
2018-02-28
Last Posted Date
2022-04-28
Lead Sponsor
Sanofi
Target Recruit Count
84
Registration Number
NCT03449758
Locations
🇫🇷

Investigational Site Number 250014, Caen, France

🇫🇷

Investigational Site Number 250006, Besancon, France

🇫🇷

Investigational Site Number 250016, Bordeaux, France

and more 30 locations

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

First Posted Date
2018-01-30
Last Posted Date
2025-04-29
Lead Sponsor
University of Nebraska
Target Recruit Count
400
Registration Number
NCT03414502
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

First Posted Date
2016-10-12
Last Posted Date
2021-07-27
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Target Recruit Count
136
Registration Number
NCT02930343
Locations
🇮🇳

Department of Clinical Immunology , Jawaharlal Institute of Post graduate Medical Educationa and Research, Pondicherry, India

Predictability Studies on the Efficacy of TNF-α Inhibitors in Chinese RA From "Real World"

Phase 4
Conditions
Rheumatoid Arthritis
Interventions
Drug: methotrexate(necessary)
Biological: etanercept
Biological: infliximab
Biological: adalimumab
Drug: NSAIDs (permitted,not necessary)
Drug: Glucocorticoids (permitted,not necessary)
First Posted Date
2016-08-25
Last Posted Date
2016-08-25
Lead Sponsor
Fen Li
Target Recruit Count
240
Registration Number
NCT02878161
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