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

Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

First Posted Date
2016-05-09
Last Posted Date
2024-04-17
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
138
Registration Number
NCT02766465
Locations
🇺🇸

Dana Farber Cancer Institute/Brigham & Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Boston University, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute/Massachusetts General Hospital, Boston, Massachusetts, United States

and more 32 locations

Kunxian for the Treatment of Rheumatoid Arthritis

First Posted Date
2016-05-06
Last Posted Date
2017-03-09
Lead Sponsor
Chinese SLE Treatment And Research Group
Target Recruit Count
428
Registration Number
NCT02764515
Locations
🇨🇳

The Third Affiliated Hospital to SUN YAT-SEN University, Guangzhou, Guangdong, China

🇨🇳

The first affiliated hospital of Zhengzhou University, Zhengzhou, Henan, China

🇨🇳

Minda Hospital of Hubei Province, Enshi, Hubei, China

and more 13 locations

Triple Combination Therapy in High Risk Crohn's Disease (CD)

First Posted Date
2016-05-06
Last Posted Date
2023-07-14
Lead Sponsor
Takeda
Target Recruit Count
55
Registration Number
NCT02764762
Locations
🇺🇸

Cotton O'Neil Clinical Research, Topeka, Kansas, United States

🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

🇨🇦

PerCuro Clinical Research Ltd, Victoria, British Columbia, Canada

and more 29 locations

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

First Posted Date
2016-05-05
Last Posted Date
2019-06-14
Lead Sponsor
Biocad
Target Recruit Count
426
Registration Number
NCT02762838
Locations
🇧🇾

Institution of Healthcare "First Municipal Clinical Hospital", Minsk, Belarus

🇮🇳

S.P Medical College & A.G. of Hospitals, Bīkaner, India

🇧🇾

Institution of Healthcare "Ordena Trudovogo Krasnogo Znameni Regional Clinical Hospital", Minsk, Belarus

and more 36 locations

MTX Discontinuation and Vaccine Response

First Posted Date
2016-04-22
Last Posted Date
2018-10-04
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
277
Registration Number
NCT02748785
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Reduced Intensity Conditioning Allogeneic Hematopoietic Stem Cell Transplant (HSCT) For Lymphoma

First Posted Date
2016-03-31
Last Posted Date
2017-03-22
Lead Sponsor
Massachusetts General Hospital
Registration Number
NCT02724904
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

First Posted Date
2016-03-31
Last Posted Date
2024-11-29
Lead Sponsor
Incyte Corporation
Target Recruit Count
171
Registration Number
NCT02723994
Locations
🇺🇸

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

🇺🇸

Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

🇺🇸

Texas Childrens Hospital, Houston, Texas, United States

and more 105 locations

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

First Posted Date
2016-03-30
Last Posted Date
2016-09-13
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Target Recruit Count
360
Registration Number
NCT02722694
Locations
🇨🇳

Peking union medical college hospital, Beijing, Beijing, China

Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate

Phase 2
Conditions
Interventions
First Posted Date
2016-03-22
Last Posted Date
2016-03-22
Lead Sponsor
Central South University
Target Recruit Count
400
Registration Number
NCT02715947
Locations
🇨🇳

Xiangya Hospital Central South University, Changsha, Hunan, China

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