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.
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2006/01/18 | Phase 2 | Terminated | |||
2006/01/13 | Phase 2 | Completed | |||
2006/01/13 | Not Applicable | Completed | |||
2006/01/11 | Phase 3 | Terminated | Children's Cancer and Leukaemia Group | ||
2005/12/22 | N/A | Completed | |||
2005/12/21 | Phase 2 | Completed | |||
2005/12/16 | Phase 3 | Completed | |||
2005/12/13 | Phase 3 | Completed | |||
2005/12/13 | Phase 3 | Completed | |||
2005/12/07 | Phase 2 | Terminated |
FDA Drug Approvals
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HSA Drug Approvals
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