MedPath

Methotrexate

Generic Name
Methotrexate
Brand Names
Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo
Drug Type
Small Molecule
Chemical Formula
C20H22N8O5
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

Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders

Phase 2
Completed
Conditions
Congenital Amegakaryocytic Thrombocytopenia
Severe Congenital Neutropenia
Diamond-blackfan Anemia
Leukemia
Myelodysplastic Syndromes
Interventions
Biological: alemtuzumab
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
First Posted Date
2006-03-13
Last Posted Date
2017-09-28
Lead Sponsor
University of California, San Francisco
Target Recruit Count
35
Registration Number
NCT00301834
Locations
🇺🇸

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

🇺🇸

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-03-06
Last Posted Date
2017-07-28
Lead Sponsor
Genentech, Inc.
Target Recruit Count
755
Registration Number
NCT00299104

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2006-03-06
Last Posted Date
2017-04-17
Lead Sponsor
Genentech, Inc.
Target Recruit Count
511
Registration Number
NCT00299130

Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma

First Posted Date
2006-03-06
Last Posted Date
2021-09-21
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
50
Registration Number
NCT00299182
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Biological: IDEC-C2B8 (rituximab)
Drug: Placebo
Drug: Methotrexate
Drug: Etanercept
Drug: Adalimumab
Drug: Methylprednisolone
Dietary Supplement: Folate
First Posted Date
2006-03-02
Last Posted Date
2015-09-28
Lead Sponsor
Biogen
Target Recruit Count
54
Registration Number
NCT00298272
Locations
🇺🇸

Research Site, Burlington, Vermont, United States

🇺🇸

Research site, Chardon, Ohio, United States

Methotrexate in the Treatment of Axial Spondyloarthritis

Phase 4
Withdrawn
Conditions
Spondylarthropathies
Spondylitis, Ankylosing
First Posted Date
2006-03-01
Last Posted Date
2009-01-05
Lead Sponsor
Rheumatism Foundation Hospital
Target Recruit Count
120
Registration Number
NCT00298012
Locations
🇫🇮

Rheumatism Foundation Hospital, Heinola, Finland

🇫🇮

Helsinki University Central Hospital, Helsinki, Finland

🇫🇮

Central Finland Central Hospital, Jyväskylä, Finland

and more 2 locations

Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer

Not Applicable
Completed
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions
Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2006-02-24
Last Posted Date
2012-10-04
Lead Sponsor
University of California, San Francisco
Target Recruit Count
25
Registration Number
NCT00296023
Locations
🇺🇸

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

🇺🇸

UCSF Comprehensive Cancer Center, San Francisco, California, United States

Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Phase 3
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2006-02-24
Last Posted Date
2021-02-23
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
77
Registration Number
NCT00296010
Locations
🇧🇪

Centre Hospitalier Etterbeek Ixelles, Brussels, Belgium

🇧🇪

AZ Groeninge - Oncologisch Centrum, Kortrijk, Belgium

🇧🇪

Institut Jules Bordet, Brussels, Belgium

and more 30 locations

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

Not Applicable
Conditions
Chronic Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
First Posted Date
2006-02-24
Last Posted Date
2014-01-06
Lead Sponsor
University of California, San Francisco
Target Recruit Count
35
Registration Number
NCT00295997
Locations
🇺🇸

UCSF Comprehensive Cancer Center, San Francisco, California, United States

🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Phase 1
Conditions
Central Nervous System Lymphoma
Interventions
Drug: Carboplatin
Drug: Mannitol
Drug: Methotrexate
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug: Sodium Thiosulfate
First Posted Date
2006-02-17
Last Posted Date
2021-09-22
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
81
Registration Number
NCT00293475
Locations
🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States

and more 1 locations
© Copyright 2025. All Rights Reserved by MedPath