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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 With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Phase 2
Active, not recruiting
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Adult L1 Acute Lymphoblastic Leukemia
Adult L2 Acute Lymphoblastic Leukemia
Adult T Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2008-11-18
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
97
Registration Number
NCT00792948
Locations
🇺🇸

Cancer Center of Kansas-Kingman, Kingman, Kansas, United States

🇺🇸

Lawrence Memorial Hospital, Lawrence, Kansas, United States

🇺🇸

Southwest Medical Center, Liberal, Kansas, United States

and more 154 locations

Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers

Phase 1
Completed
Conditions
Malaria
Interventions
First Posted Date
2008-11-14
Last Posted Date
2012-04-24
Lead Sponsor
KEMRI-Wellcome Trust Collaborative Research Program
Target Recruit Count
25
Registration Number
NCT00791531
Locations
🇰🇪

Kenya Medical Research Institute, Center for Clinical Research, Nairobi, Kenya

Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer

Phase 2
Completed
Conditions
Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions
Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: nonmyeloablative allogeneic HSCT
First Posted Date
2008-11-10
Last Posted Date
2012-10-01
Lead Sponsor
Northside Hospital, Inc.
Target Recruit Count
24
Registration Number
NCT00787761
Locations
🇺🇸

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States

Juvenile Idiopathic Arthritis (JIA) Registry

Completed
Conditions
Juvenile Idiopathic Arthritis
JIA
Interventions
Biological: adalimumab
Drug: Methotrexate
First Posted Date
2008-10-31
Last Posted Date
2024-02-23
Lead Sponsor
AbbVie
Target Recruit Count
849
Registration Number
NCT00783510
Locations
🇺🇸

University of Louisville /ID# 23507, Louisville, Kentucky, United States

🇺🇸

Arthritis Care Spec. of MD /ID# 21961, Ellicott City, Maryland, United States

🇺🇸

North Shore University Hospital /ID# 21022, New Hyde Park, New York, United States

and more 89 locations

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: placebo
Drug: ocrelizumab 500mg
Drug: ocrelizumabu 50mg
Drug: ocrelizumabu 200mg
Drug: methotrexate
First Posted Date
2008-10-24
Last Posted Date
2015-03-25
Lead Sponsor
Chugai Pharmaceutical
Target Recruit Count
152
Registration Number
NCT00779220
Locations
🇯🇵

Chugoku region, Chugoku, Japan

🇯🇵

Sikoku region, Sikoku, Japan

🇯🇵

Chubu region, Chubu, Japan

and more 4 locations

A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-10-07
Last Posted Date
2013-07-02
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
104
Registration Number
NCT00767325
Locations
🇬🇧

Local Institution, Leeds, North Yorkshire, United Kingdom

Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2008-09-26
Last Posted Date
2010-06-11
Lead Sponsor
Takeda
Target Recruit Count
432
Registration Number
NCT00760864

Efficacy and Safety of TAK-783 in Subjects With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Drug: TAK-783 and methotrexate
Drug: Methotrexate
First Posted Date
2008-09-26
Last Posted Date
2010-06-11
Lead Sponsor
Takeda
Target Recruit Count
224
Registration Number
NCT00760968

METhotrexate Therapy Effects in the Physical Capacity of Patients With ISchemic Heart Failure (METIS Trial)

Phase 2
Completed
Conditions
Heart Failure
Myocardial Ischemia
Interventions
Drug: Methotrexate
Drug: Placebo
First Posted Date
2008-09-25
Last Posted Date
2013-05-08
Lead Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Target Recruit Count
50
Registration Number
NCT00759811
Locations
🇧🇷

Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil

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