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 or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis

Phase 2
Completed
Conditions
Leukemia
Interventions
First Posted Date
2015-03-11
Last Posted Date
2024-01-17
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
18
Registration Number
NCT02385110
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX

Completed
Conditions
Osteosarcoma
First Posted Date
2015-03-10
Last Posted Date
2016-09-05
Lead Sponsor
Isofol Medical AB
Target Recruit Count
116
Registration Number
NCT02383901
Locations
🇳🇴

Oslo University Hospital, Oslo, Norway

🇭🇺

Semmelweis Egyetem II. Sz. Gyermekklinika, Budapest, Hungary

🇸🇪

Karolinska University Hospital, Sweden, Stockholm, Sweden

and more 2 locations

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo
Drug: Namilumab
Drug: Methotrexate
Drug: Folic/folinic acid
First Posted Date
2015-03-04
Last Posted Date
2018-09-14
Lead Sponsor
Takeda
Target Recruit Count
108
Registration Number
NCT02379091

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

First Posted Date
2015-03-03
Last Posted Date
2022-09-21
Lead Sponsor
Amgen
Target Recruit Count
851
Registration Number
NCT02376790
Locations
🇬🇧

Research Site, Nottingham, United Kingdom

Treatments Against RA and Effect on FDG-PET/CT

First Posted Date
2015-02-27
Last Posted Date
2022-10-26
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
159
Registration Number
NCT02374021
Locations
🇺🇸

IRIS Research and Development, Plantation, Florida, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 28 locations

Effect of Omega-3 Fatty Acids on Methotrexate Induced Hepatotoxicity in Children With Acute Lymphoblastic Leukemia

Phase 2
Completed
Conditions
Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2015-02-27
Last Posted Date
2015-02-27
Lead Sponsor
Nancy Samir Elbarbary
Target Recruit Count
70
Registration Number
NCT02373579

Inflammation and Coronary Endothelial Function

Phase 2
Completed
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2015-02-19
Last Posted Date
2021-10-21
Lead Sponsor
Johns Hopkins University
Target Recruit Count
111
Registration Number
NCT02366091
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer

Phase 3
Completed
Conditions
Recurrent or Metastatic Head and Neck Carcinoma
Interventions
First Posted Date
2015-01-27
Last Posted Date
2019-03-05
Lead Sponsor
Pierre Fabre Medicament
Target Recruit Count
459
Registration Number
NCT02347332
Locations
🇫🇷

Institut de Recherche Pierre Fabre, Toulouse, France

Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301)

Phase 3
Completed
Conditions
Acute Leukemia
Myelodysplasia
Interventions
Procedure: Mobilized CD34-selected Peripheral Blood Stem Cell graft
Procedure: Unmanipulated Bone Marrow Graft with Tacrolimus/Methotrexate
Procedure: Unmanipulated Bone Marrow Graft with Cyclophosphamide
Drug: Tacrolimus
Drug: Cyclophosphamide
Drug: Methotrexate
First Posted Date
2015-01-26
Last Posted Date
2023-03-07
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
346
Registration Number
NCT02345850
Locations
🇺🇸

Johns Hopkins/SKCCC, Baltimore, Maryland, United States

🇺🇸

Dana Farber Cancer Institute/Brigham & Women's, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute/Massachusetts General Hospital, Boston, Massachusetts, United States

and more 25 locations

Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

Phase 4
Conditions
Beta-Thalassemia Major
Interventions
First Posted Date
2015-01-19
Last Posted Date
2015-01-19
Lead Sponsor
Affiliated hospital of guangxi medical university,china
Target Recruit Count
40
Registration Number
NCT02342145
Locations
🇨🇳

The affiliated hospital of guangxi medical university, Nanning, Guangxi, China

🇨🇳

Affiliated Drum Tower Hospital, Nanjing medical university, Nanjing, Jiangsu, China

🇨🇳

Kunming general hospital of chengdu military region, Kunming, Yunnan, China

and more 2 locations
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