Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

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

Clinical Trials

Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

Completed

Conditions: Childhood Acute Lymphoblastic Leukemia in Remission

Interventions: Behavioral: Compliance Monitoring
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Questionnaire Administration
Other: Study of Socioeconomic and Demographic Variables

First Posted Date: 2005-12-22

Last Posted Date: 2020-07-07

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 720

Registration Number: NCT00268528

Locations: 🇺🇸
T C Thompson Children's Hospital, Chattanooga, Tennessee, United States
🇺🇸
University of Vermont and State Agricultural College, Burlington, Vermont, United States
🇺🇸
Newark Beth Israel Medical Center, Newark, New Jersey, United States

and more 132 locations

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma

Phase 2

Completed

Conditions: AIDS-Related-Primary Central Nervous System Lymphoma

Interventions: Drug: Methotrexate
Drug: Rituximab
Drug: Leucovorin

First Posted Date: 2005-12-21

Last Posted Date: 2020-06-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT00267865

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: placebo
Drug: rituximab
Drug: methotrexate
Drug: folate

First Posted Date: 2005-12-16

Last Posted Date: 2013-10-25

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 559

Registration Number: NCT00266227

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Golimumab 100 mg
Drug: Golimumab 50 mg
Drug: Methotrexate
Drug: Placebo capsules
Drug: Placebo injection

First Posted Date: 2005-12-13

Last Posted Date: 2014-04-29

Lead Sponsor: Centocor, Inc.

Target Recruit Count: 444

Registration Number: NCT00264550

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

Phase 2

Terminated

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia

Interventions: Biological: alemtuzumab
Drug: asparaginase
Drug: methotrexate
Drug: dexamethasone
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: vincristine

First Posted Date: 2005-12-07

Last Posted Date: 2015-05-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT00262925

Locations: 🇺🇸
Mercy Hospital and Medical Center, Chicago, Illinois, United States
🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸
Rush - Copley Medical Center, Aurora, Illinois, United States

and more 55 locations