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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

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD

Phase 2
Active, not recruiting
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Donor
Recurrent Acute Lymphoblastic Leukemia
Refractory Acute Myeloid Leukemia
Childhood Acute Myeloid Leukemia in Remission
Myelodysplastic Syndrome With Excess Blasts-2
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Biphenotypic Leukemia
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Tacrolimus
Drug: Thiotepa
Radiation: Total-Body Irradiation
First Posted Date
2014-08-20
Last Posted Date
2024-08-19
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
84
Registration Number
NCT02220985
Locations
🇺🇸

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study of Tacrolimus/Methotrexate and Tocilizumab to Prevent Acute Graft-Versus-Host Disease (AGVD) After Allogeneic Hematopoietic Stem Cell Transplant

Phase 2
Completed
Conditions
Hematopoietic Stem Cell Transplantation
Interventions
First Posted Date
2014-08-01
Last Posted Date
2023-03-09
Lead Sponsor
William R. Drobyski, MD
Target Recruit Count
45
Registration Number
NCT02206035
Locations
🇺🇸

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Phase 2
Recruiting
Conditions
Langerhans Cell Histiocytosis
Interventions
Procedure: hematopoietic stem cell transplantation (RIC-HSCT)
Drug: Prednisone
Drug: 2-chlorodeoxyadenosine
Drug: Vinblastine
Biological: Intravenous immunoglobulin
Drug: mercaptopurine
Drug: INDOMETHACIN
Drug: Methotrexate
Drug: Cytosine Arabinoside
First Posted Date
2014-07-31
Last Posted Date
2023-03-23
Lead Sponsor
North American Consortium for Histiocytosis
Target Recruit Count
1400
Registration Number
NCT02205762
Locations
🇺🇸

Children's Medical Center Dallas, UT Southwestern, Dallas, Texas, United States

🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 35 locations

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

First Posted Date
2014-07-30
Last Posted Date
2025-01-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
93
Registration Number
NCT02203526
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study for Improving the Outcome of Childhood Acute Promyeloid Leukemia

Phase 4
Completed
Conditions
Childhood Acute Promyelocytic Leukemia
Interventions
Drug: ATO
Drug: RIF
Drug: ATRA
Drug: mitoxantrone
Drug: Ara-C
Drug: MTX
Drug: 6MP
Other: intrathecal injection
First Posted Date
2014-07-25
Last Posted Date
2022-05-10
Lead Sponsor
South China Children's Leukemia Group
Target Recruit Count
176
Registration Number
NCT02200978
Locations
🇨🇳

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Phase 3
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2014-07-22
Last Posted Date
2018-03-19
Lead Sponsor
AbbVie
Target Recruit Count
46
Registration Number
NCT02196701

S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer

First Posted Date
2014-06-30
Last Posted Date
2024-06-11
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
237
Registration Number
NCT02177695
Locations
🇺🇸

Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States

🇺🇸

Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States

🇺🇸

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States

and more 563 locations

A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

Phase 4
Completed
Conditions
Crohn's Disease
Interventions
First Posted Date
2014-06-27
Last Posted Date
2022-08-03
Lead Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Target Recruit Count
211
Registration Number
NCT02177071
Locations
🇦🇺

St Vincent Hospital, Melbourne, Australia

🇫🇷

Chu Clermont-Ferrand, Clermont-ferrand, Auvergne Rhone Alpes, France

🇫🇷

CHU LYON, Pierre Benite, Auvergne Rhone Alpes, France

and more 24 locations

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

Phase 3
Completed
Conditions
Ectopic Pregnancy
Persistent Pregnancy of Unknown Location
Interventions
Other: Expectant Management
Drug: Methotrexate
Procedure: Uterine Evacuation
First Posted Date
2014-06-02
Last Posted Date
2020-12-08
Lead Sponsor
Yale University
Target Recruit Count
255
Registration Number
NCT02152696
Locations
🇺🇸

Wayne State University, Southfield, Michigan, United States

🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

University of South Florida, Tampa, Florida, United States

and more 14 locations

A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: Certolizumab Pegol
Other: Placebo
Drug: Methotrexate
First Posted Date
2014-05-30
Last Posted Date
2018-06-28
Lead Sponsor
UCB Pharma SA, Belgium
Target Recruit Count
430
Registration Number
NCT02151851
Locations
🇨🇳

017, Changsha, China

🇨🇳

012, Chengdu, China

🇨🇳

031, Kunming, China

and more 27 locations
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