MedPath

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

GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: GLPG0259
Drug: placebo
Drug: Methotrexate
First Posted Date
2009-10-05
Last Posted Date
2012-02-20
Lead Sponsor
Galapagos NV
Target Recruit Count
24
Registration Number
NCT00989703
Locations
🇧🇪

SGS Stuivenberg, Antwerp, Belgium

Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

Phase 2
Conditions
Primary Non Hodgkin Lymphoma of the Central Nervous System
First Posted Date
2009-10-05
Last Posted Date
2009-10-05
Lead Sponsor
University Hospital Freiburg
Target Recruit Count
56
Registration Number
NCT00989352
Locations
🇩🇪

University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology, Freiburg, Germany

Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL

Phase 1
Terminated
Conditions
Relapsed T-Cell Lymphoblastic Lymphoma
Relapsed T-Cell Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2009-09-22
Last Posted Date
2020-10-01
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
23
Registration Number
NCT00981799
Locations
🇺🇸

Childrens Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

University of Texas at Southwestern, Dallas, Texas, United States

🇺🇸

University of Miami Cancer Center, Miami, Florida, United States

and more 34 locations

Combination Chemotherapy and Rituximab in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

Phase 2
Conditions
Lymphoma
First Posted Date
2009-09-10
Last Posted Date
2013-08-26
Lead Sponsor
Cancer Research UK
Target Recruit Count
150
Registration Number
NCT00974792
Locations
🇬🇧

Nottingham City Hospital, Nottingham, England, United Kingdom

Treatment of Older Adults With Acute Lymphoblastic Leukemia

First Posted Date
2009-09-09
Last Posted Date
2017-03-30
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
30
Registration Number
NCT00973752
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

RAD001 Study in Treatment of Relapsed or Refractory Acute Lymphocytic Leukemia

First Posted Date
2009-08-28
Last Posted Date
2019-02-27
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
24
Registration Number
NCT00968253
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

First Posted Date
2009-08-27
Last Posted Date
2013-08-12
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
470
Registration Number
NCT00967057
Locations
🇬🇧

Great Ormond Street Hospital for Children, London, England, United Kingdom

🇬🇧

Christie Hospital, Manchester, England, United Kingdom

🇦🇺

Women's and Children's Hospital, North Adelaide, South Australia, Australia

and more 3 locations

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-08-25
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
29
Registration Number
NCT00965653

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

Phase 1
Completed
Conditions
Active Rheumatoid Arthritis
Interventions
Drug: ATN-103
Drug: Placebo
Drug: Methotrexate
First Posted Date
2009-08-14
Last Posted Date
2013-01-30
Lead Sponsor
Ablynx, a Sanofi company
Target Recruit Count
252
Registration Number
NCT00959036
Locations
🇨🇭

Investigational Site, Chur, Switzerland

Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency

Phase 2
Terminated
Conditions
Advanced Colorectal Cancer
First Posted Date
2009-08-04
Last Posted Date
2016-10-14
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
2
Registration Number
NCT00952016
Locations
🇬🇧

The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath