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

Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

First Posted Date
2008-06-30
Last Posted Date
2020-03-05
Lead Sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Target Recruit Count
2231
Registration Number
NCT00707083
Locations
🇨🇳

Prince of Wales Hospital, Hong Kong, China

🇨🇳

Queen Mary Hospital - Hong Kong, Hong Kong, China

Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

Phase 4
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-06-30
Last Posted Date
2011-06-21
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
141
Registration Number
NCT00706797

An Exploratory Study of the Safety and Efficacy of Prophylactic Immunomodulatory Treatment in Myozyme-naive Cross-Reacting Immunologic Material (CRIM[-]) Patients With Infantile-Onset Pompe Disease

Phase 4
Completed
Conditions
Pompe Disease
Glycogen Storage Disease Type II
Interventions
Biological: Alglucosidase Alfa
Drug: Methotrexate
Drug: Rituximab
First Posted Date
2008-06-19
Last Posted Date
2014-05-13
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
4
Registration Number
NCT00701129
Locations
🇺🇸

Kosair Children's Hospital, Louisville, Kentucky, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-06-11
Last Posted Date
2011-02-17
Lead Sponsor
Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
Target Recruit Count
19
Registration Number
NCT00695188
Locations
🇦🇹

Rheumazentrum Wien Oberlaa, Wien, Austria

🇦🇹

Kaiser-Franz-Josef-Spital, Wien, Austria

Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma

First Posted Date
2008-06-04
Last Posted Date
2009-07-08
Lead Sponsor
University Hospital Southampton NHS Foundation Trust
Target Recruit Count
120
Registration Number
NCT00689845
Locations
🇬🇧

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

🇬🇧

Christie Hospital, Manchester, England, United Kingdom

🇬🇧

Southampton General Hospital, Southampton, England, United Kingdom

and more 5 locations

Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

First Posted Date
2008-06-02
Last Posted Date
2009-06-17
Lead Sponsor
National Cancer Centre, Singapore
Target Recruit Count
70
Registration Number
NCT00687648
Locations
🇸🇬

National Cancer Centre - Singapore, Singapore, Singapore

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Active, not recruiting
Conditions
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Long-term Effects Secondary to Cancer Therapy in Children
Ototoxicity
First Posted Date
2008-05-23
Last Posted Date
2013-09-20
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
50
Registration Number
NCT00683319
Locations
🇬🇧

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

🇬🇧

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

🇬🇧

Birmingham Children's Hospital, Birmingham, England, United Kingdom

and more 7 locations

A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
Drug: ABT-874
Drug: Methotrexate
First Posted Date
2008-05-19
Last Posted Date
2013-01-29
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
317
Registration Number
NCT00679731
Locations
🇦🇹

Site Reference ID/Investigator# 12763, Vienna, Austria

🇨🇦

Site Reference ID/Investigator# 13104, Barrie, Canada

🇸🇪

Site Reference ID/Investigator# 8185, Stockholm, Sweden

and more 40 locations

A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-05-07
Last Posted Date
2020-12-04
Lead Sponsor
Genentech, Inc.
Target Recruit Count
314
Registration Number
NCT00673920

Doxorubicin With Cisplatin, High-Dose Methotrexate, and Additional Risk-Adapted Outpatient Chemotherapy

Not Applicable
Terminated
Conditions
Osteosarcoma
Interventions
First Posted Date
2008-05-07
Last Posted Date
2014-09-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
7
Registration Number
NCT00673179
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath