Methotrexate

Overview

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

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer	2006/01/25	NCT00281879	Phase 2	Terminated	OHSU Knight Cancer Institute
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas	2006/01/18	NCT00278278	Phase 3	UNKNOWN	German Society for Pediatric Oncology and Hematology GPOH gGmbH
Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia	2006/01/18	NCT00278265	Phase 2	Terminated	German CLL Study Group
Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis	2006/01/13	NCT00276757	Not Applicable	Completed	Histiocyte Society
Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia	2006/01/13	NCT00276601	Phase 2	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma	2006/01/11	NCT00275106	Phase 3	Terminated	Children's Cancer and Leukaemia Group
Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission	2005/12/22	NCT00268528	N/A	Completed	Children's Oncology Group
Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma	2005/12/21	NCT00267865	Phase 2	Completed	National Cancer Institute (NCI)
A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate	2005/12/16	NCT00266227	Phase 3	Completed	Genentech, Inc.
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy	2005/12/13	NCT00264550	Phase 3	Completed	Centocor, Inc.

FDA Drug Approvals

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EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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