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

Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab

Phase 4
Terminated
Conditions
Moderate to Severe Rheumatoid Arthritis
Interventions
Biological: Etanercept
Drug: Methotrexate
First Posted Date
2013-08-23
Last Posted Date
2018-01-30
Lead Sponsor
Amgen
Target Recruit Count
90
Registration Number
NCT01927757
Locations
🇵🇷

Research Site, Caguas, Puerto Rico

A Novel "Pediatric-Inspired" Regimen With Reduced Myelosuppressive Drugs for Adults (Aged 18-60) With Newly Diagnosed Ph Negative Acute Lymphoblastic Leukemia

First Posted Date
2013-08-12
Last Posted Date
2023-10-24
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
39
Registration Number
NCT01920737
Locations
🇺🇸

Weill Cornell Medical Center, New York, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

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

and more 1 locations

Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis

Phase 2
Completed
Conditions
Uveitis
Interventions
Drug: Sarilumab
Drug: Prednisone
Drug: Methotrexate
Drug: Folic/folinic acid
Other: Placebo (for Sarilumab)
First Posted Date
2013-07-16
Last Posted Date
2017-06-20
Lead Sponsor
Sanofi
Target Recruit Count
58
Registration Number
NCT01900431
Locations
🇺🇸

Investigational Site Number 840007, Cleveland, Ohio, United States

🇹🇷

Investigational Site Number 792004, Izmir, Turkey

🇹🇷

Investigational Site Number 792006, Izmir, Turkey

and more 17 locations

Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Phase 4
Completed
Conditions
Ankylosing Spondylitis
Interventions
First Posted Date
2013-07-10
Last Posted Date
2015-09-29
Lead Sponsor
University Hospital, Tours
Target Recruit Count
110
Registration Number
NCT01895764
Locations
🇫🇷

Médecine polyvalente, CH de SAINT NAZAIRE, Saint Nazaire, France

🇫🇷

Rhumatologie, CHRU de RENNES, Rennes, France

🇫🇷

Rhumatologie, CHD LA ROCHE SUR YON, La Roche Sur Yon, France

and more 8 locations

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Methotrexate

Phase 1
Completed
Conditions
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Methotrexate
Pharmacokinetics of 7-hydroxymethotrexate
Healthy Subjects
Interventions
First Posted Date
2013-06-24
Last Posted Date
2013-06-24
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT01884636
Locations
🇺🇸

California Clinical Trials Medical Group, Glendale, California, United States

Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer

Phase 3
Completed
Conditions
Head Neck Cancer Squamous Cell Recurrent
Interventions
First Posted Date
2013-06-24
Last Posted Date
2024-02-09
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
82
Registration Number
NCT01884623
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, Val De Marne, France

Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Phase 4
Completed
Conditions
Ectopic Pregnancy
Interventions
Drug: Placebo
Drug: Methotrexate
First Posted Date
2013-06-12
Last Posted Date
2013-06-12
Lead Sponsor
Federal University of São Paulo
Target Recruit Count
25
Registration Number
NCT01876004
Locations
🇧🇷

Federal University of Sao Paulo, São Paulo, SP, Brazil

Initial Treatment With Golimumab in Early PsA

Phase 3
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2013-06-07
Last Posted Date
2018-11-26
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
51
Registration Number
NCT01871649
Locations
🇳🇱

Reade, Amsterdam, Noord Holland, Netherlands

🇳🇱

Academic Medical Center/University of Amsterdam, Amsterdam, Noord Holland, Netherlands

Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Methotrexate
Drug: Combination
Drug: Combination Steroid
First Posted Date
2013-06-05
Last Posted Date
2013-06-05
Lead Sponsor
All India Institute of Medical Sciences, New Delhi
Target Recruit Count
60
Registration Number
NCT01870128
Locations
🇮🇳

AIIMS, New Delhi, Delhi, India

© Copyright 2025. All Rights Reserved by MedPath