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

Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Not Applicable

Completed

Conditions: Leukemia

First Posted Date: 2010-07-05

Last Posted Date: 2021-09-13

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 76

Registration Number: NCT01156883

Locations: 🇮🇹
Azienda Ospedaliera - Nuovo Ospedale "Torrette", Ancona, Italy
🇮🇹
USL 8 - Ospedale S.Donato, Arezzo, Italy
🇮🇹
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari, Bari, Italy

and more 40 locations

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept
Drug: Methotrexate
Drug: Abatacept placebo
Drug: Methotrexate placebo

First Posted Date: 2010-06-11

Last Posted Date: 2016-01-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 511

Registration Number: NCT01142726

Locations: 🇺🇸
Johns Hopkins University Division Of Rheumatology, Baltimore, Maryland, United States
🇺🇸
Physician Research Collaboration, Llc, Lincoln, Nebraska, United States
🇺🇸
Rheumatology Associates Of North Alabama, P.C., Huntsville, Alabama, United States

and more 13 locations

National Psoriasis Foundation - Dendritic Cell-Specific Transmembrane Protein (DC-Stamp) Biomarker Study

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Anti-TNF
Drug: Methotrexate

First Posted Date: 2010-05-14

Last Posted Date: 2015-09-21

Lead Sponsor: University of Rochester

Target Recruit Count: 22

Registration Number: NCT01123265

Locations: 🇺🇸
University of Rochester, Rochester, New York, United States

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

Phase 2

Terminated

Conditions: Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

Interventions: Biological: anti-thymocyte globulin
Biological: donor lymphocytes
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Other: reduced-intensity transplant conditioning procedure
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2010-05-06

Last Posted Date: 2017-03-24

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 6

Registration Number: NCT01118013

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
🇺🇸
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States

and more 7 locations

A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Phase 4

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: rituximab [Mabthera/Rituxan]
Drug: placebo
Drug: methotrexate

First Posted Date: 2010-05-05

Last Posted Date: 2014-03-28

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 2

Registration Number: NCT01117129

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia

Phase 3

Completed

Conditions: Leukemia

Interventions: Drug: PEG-L-asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mercaptopurine
Drug: ifosfamide
Drug: methotrexate
Drug: vincristine sulfate
Drug: prednisone
Radiation: Radiation Therapy
Drug: thioguanine
Drug: vindesine
Drug: daunoxome
Drug: fludarabine

First Posted Date: 2010-05-05

Last Posted Date: 2022-05-24

Lead Sponsor: University Hospital Schleswig-Holstein

Target Recruit Count: 6136

Registration Number: NCT01117441

Locations: 🇦🇹
A.oe. Landeskrankenhaus Klagenfurt, Abt. für Kinder- und Jugendheilkunde, Klagenfurt, Austria
🇨🇿
University Hospital Brno, Department of Pediatric Oncology, Brno, Czechia
🇩🇪
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie, Berlin, Germany

and more 134 locations

Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

Phase 2

Completed

Conditions: Hemophagocytic Lymphohistiocytosis

Interventions: Drug: ATG, rabbit
Drug: Etoposide
Drug: Methotrexate
Drug: hydrocortisone
Drug: Dexamethasone

First Posted Date: 2010-04-15

Last Posted Date: 2020-10-19

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Target Recruit Count: 31

Registration Number: NCT01104025

Locations: 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
Oregon Health and Science University, Portland, Oregon, United States

and more 11 locations