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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

Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

Not Applicable
Completed
Conditions
Childhood Langerhans Cell Histiocytosis
First Posted Date
2006-01-13
Last Posted Date
2014-01-10
Lead Sponsor
Histiocyte Society
Target Recruit Count
376
Registration Number
NCT00276757
Locations
🇬🇧

Sir James Spence Institute of Child Health at Royal Victoria Infirmary, Newcastle-Upon-Tyne, England, United Kingdom

🇬🇧

Birmingham Children's Hospital, Birmingham, England, United Kingdom

🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

and more 29 locations

Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

Phase 2
Completed
Conditions
Leukemia
First Posted Date
2006-01-13
Last Posted Date
2014-04-17
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Registration Number
NCT00276601
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

🇺🇸

Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 4 locations

Prednisolone or Dexamethasone Combined With Chemotherapy in Treating Young Patients With Newly Diagnosed Lymphoblastic Lymphoma

Phase 3
Terminated
Conditions
Lymphoma
First Posted Date
2006-01-11
Last Posted Date
2013-07-10
Lead Sponsor
Children's Cancer and Leukaemia Group
Target Recruit Count
600
Registration Number
NCT00275106
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

🇬🇧

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

🇩🇪

Kinderklinik, Giessen, Germany

and more 18 locations

Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

Completed
Conditions
Childhood Acute Lymphoblastic Leukemia in Remission
Interventions
Behavioral: Compliance Monitoring
Other: Laboratory Biomarker Analysis
Drug: Mercaptopurine
Drug: Methotrexate
Other: Questionnaire Administration
Other: Study of Socioeconomic and Demographic Variables
First Posted Date
2005-12-22
Last Posted Date
2020-07-07
Lead Sponsor
Children's Oncology Group
Target Recruit Count
720
Registration Number
NCT00268528
Locations
🇺🇸

T C Thompson Children's Hospital, Chattanooga, Tennessee, United States

🇺🇸

University of Vermont and State Agricultural College, Burlington, Vermont, United States

🇺🇸

Newark Beth Israel Medical Center, Newark, New Jersey, United States

and more 132 locations

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma

Phase 2
Completed
Conditions
AIDS-Related-Primary Central Nervous System Lymphoma
Interventions
First Posted Date
2005-12-21
Last Posted Date
2020-06-01
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
12
Registration Number
NCT00267865
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-12-16
Last Posted Date
2013-10-25
Lead Sponsor
Genentech, Inc.
Target Recruit Count
559
Registration Number
NCT00266227

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Golimumab 50 mg
Drug: Golimumab 100 mg
Drug: Methotrexate
Drug: Placebo capsules
Drug: Placebo injection
First Posted Date
2005-12-13
Last Posted Date
2014-04-29
Lead Sponsor
Centocor, Inc.
Target Recruit Count
444
Registration Number
NCT00264550

Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2
Terminated
Conditions
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2005-12-07
Last Posted Date
2015-05-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
12
Registration Number
NCT00262925
Locations
🇺🇸

Mercy Hospital and Medical Center, Chicago, Illinois, United States

🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

🇺🇸

Rush - Copley Medical Center, Aurora, Illinois, United States

and more 55 locations

Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-11-29
Last Posted Date
2014-07-17
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
755
Registration Number
NCT00259610
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

G-CSF-Treated Donor Bone Marrow Transplant in Treating Patients With Hematologic Disorders

Not Applicable
Terminated
Conditions
Myelodysplastic/Myeloproliferative Diseases
Lymphoma
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Sarcoma
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
First Posted Date
2005-11-15
Last Posted Date
2012-05-28
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
4
Registration Number
NCT00253552
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

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