Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
CAS Number
59-05-2
Unique Ingredient Identifier
YL5FZ2Y5U1
Background

Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division. Because of these effects, methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.

Due to the toxic effects of methotrexate, it is indicated for treatment of some forms of arthritis and severe psoriasis only if first line treatment has failed or patients are intolerant of those treatments.

Methotrexate was granted FDA approval on 7 December 1953.

Indication

Methotrexate oral solution is indicated for pediatric acute lymphoblastic leukemia and pediatric polyarticular juvenile idiopathic arthritis. Methotrexate injections for subcutaneous use are indicated for severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe, recalcitrant, disabling psoriasis.

Other formulations are indicated to treat gestational choriocarcinoma, chorioadenoma destruens, hydatiform mole, breast cancer, epidermoid cancer of the head and neck, advanced mycosis fungoides, lung cancer, and advanced non-Hodgkin's lymphoma. It is also used in the maintenance of acute lymphocytic leukemia. Methotrexate is also given before treatment with leucovorin to prolong relapse-free survival following surgical removal of a tumour in non-metastatic osteosarcoma.

Associated Conditions
Acute Lymphoblastic Leukemia (ALL), Acute Promyelocytic Leukemia, Bladder Cancer, Breast Cancer, Central Nervous System Lymphoma, Crohn's Disease (CD), Dermatomyositis (DM), Extrauterine Pregnancy, Gestational Trophoblastic Neoplasia, Graft-versus-host Disease (GVHD), Meningeal leukemia, Multiple Sclerosis, Mycosis Fungoides (MF), Non-Hodgkin's Lymphoma (NHL), Non-Hodgkin's Lymphoma, Relapsed, Osteosarcoma, Polyarticular Juvenile Idiopathic Arthritis, Polymyositis, Rheumatoid Arthritis, Soft Tissue Sarcoma, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Systemic Lupus Erythematosus, Uveitis, Nonleukemic meningeal cancer, Refractory Non-Hodgkin's lymphoma, Refractory Takayasu arteritis, Severe Psoriasis
Associated Therapies
Medically induced abortion

Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

First Posted Date
2017-09-11
Last Posted Date
2024-08-13
Lead Sponsor
Grupo Espanol de Investigacion en Sarcomas
Target Recruit Count
197
Registration Number
NCT03277924
Locations
🇮🇹

Istituto Nazionale dei Tumori, Milano, Italy

🇪🇸

Hospital Universitario Virgen del Rocío, Sevilla, Spain

🇪🇸

Hospital Universitari i Politècnic La Fe, Valencia, Spain

and more 10 locations

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

First Posted Date
2017-08-18
Last Posted Date
2022-07-27
Lead Sponsor
Flinders University
Target Recruit Count
124
Registration Number
NCT03254589
Locations
🇦🇺

Southern Adelaide Local Health Network, Bedford Park, South Australia, Australia

Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-08-09
Last Posted Date
2019-07-15
Lead Sponsor
Bayer
Target Recruit Count
10
Registration Number
NCT03244462
Locations
🇳🇱

PRAHealthSciences, Groningen, Netherlands

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)

First Posted Date
2017-08-04
Last Posted Date
2018-03-07
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT03239600
Locations
🇬🇧

GSK Investigational Site, Cambridge, United Kingdom

A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-07-17
Last Posted Date
2022-11-03
Lead Sponsor
AbbVie
Target Recruit Count
104
Registration Number
NCT03219437
Locations
🇧🇷

CETI - Centro de Estudos em Terapias Inovadoras /ID# 208593, Curitiba, Parana, Brazil

🇧🇷

PUC Trials-Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR /ID# 164401, Curitiba, Parana, Brazil

🇧🇷

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 164743, Botucatu, Sao Paulo, Brazil

and more 8 locations

MAP Study: Methotrexate and Adalimumab in Psoriasis

First Posted Date
2017-07-14
Last Posted Date
2019-07-09
Lead Sponsor
Jeffrey J Crowley MD
Target Recruit Count
56
Registration Number
NCT03217734
Locations
🇺🇸

Clinical Science Institute, Santa Monica, California, United States

🇺🇸

Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield, California, United States

🇺🇸

Modern Research Associates, PLLC, Dallas, Texas, United States

and more 1 locations

Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

First Posted Date
2017-07-02
Last Posted Date
2023-12-11
Lead Sponsor
University Hospital Muenster
Target Recruit Count
650
Registration Number
NCT03206671
Locations
🇫🇮

Turku University Hospital, Paediatric and Adolescent Haematology and Oncology, Turku, Finland

🇨🇭

Universitäts-Kinderspital, Pädiatrische Onkologie, Zürich, Switzerland

🇨🇭

Kinderspital Pädiatrische Hämatologie/ Onkologie, Luzern, Switzerland

and more 89 locations

Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA

First Posted Date
2017-06-01
Last Posted Date
2021-02-02
Lead Sponsor
Cinnagen
Target Recruit Count
136
Registration Number
NCT03172325
Locations
🇮🇷

Alzahra Hospital, Isfahan, Iran, Islamic Republic of

🇮🇷

Imam Reza Hospital (501 Artesh), Tehran, Iran, Islamic Republic of

🇮🇷

Noor Medical Complex, Tabriz, Iran, Islamic Republic of

and more 7 locations

Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major

First Posted Date
2017-05-31
Last Posted Date
2017-05-31
Lead Sponsor
First Affiliated Hospital of Guangxi Medical University
Target Recruit Count
30
Registration Number
NCT03171831
Locations
🇨🇳

First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

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