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

A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

Completed

Conditions: Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing

Interventions: Drug: Simponi®
Drug: Methotrexate

First Posted Date: 2011-03-14

Last Posted Date: 2016-11-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1613

Registration Number: NCT01313858

Bortezomib, Vorinostat and Dexamethasone for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

Phase 2

Terminated

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Bortezomib
Drug: Vorinostat
Drug: Dexamethasone
Drug: Methotrexate
Drug: Imatinib mesylate

First Posted Date: 2011-03-11

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 2

Registration Number: NCT01312818

Locations: 🇺🇸
Masonic Cancer Center, University if Minnesota, Minneapolis, Minnesota, United States

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Infliximab
Drug: Methylprednisolone
Drug: Methotrexate
Dietary Supplement: Folic acid

First Posted Date: 2011-03-04

Last Posted Date: 2019-11-01

Lead Sponsor: University of Leeds

Target Recruit Count: 112

Registration Number: NCT01308255

Locations: 🇬🇧
Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom

A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

Phase 4

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: tocilizumab [RoActemra/Actemra]
Drug: adalimumab
Drug: placebo to adalimumab
Drug: placebo to tocilizumab
Drug: methotrexate
Drug: folate

First Posted Date: 2011-01-26

Last Posted Date: 2014-02-10

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 96

Registration Number: NCT01283971

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Interventions: Biological: Alemtuzumab
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide Phosphate
Biological: Filgrastim
Drug: Fludarabine Phosphate
Procedure: In Vitro-Treated Peripheral Blood Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Melphalan
Drug: Mercaptopurine
Drug: Methotrexate
Biological: Pegfilgrastim
Other: Pharmacological Study
Drug: Tacrolimus
Drug: Vincristine Sulfate

First Posted Date: 2010-12-08

Last Posted Date: 2023-04-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT01256398

Locations: 🇺🇸
Rocky Mountain Cancer Centers-Longmont, Longmont, Colorado, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
🇺🇸
Longmont United Hospital, Longmont, Colorado, United States

and more 98 locations