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

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Other: Abatacept Placebo
Other: Methotrexate Placebo
Drug: Abatacept
Drug: Methotrexate
First Posted Date
2015-07-21
Last Posted Date
2021-06-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
994
Registration Number
NCT02504268
Locations
🇺🇸

Arizona Arthritis & Rheumatology Research PLLC, Sun City, Arizona, United States

🇺🇸

Rheumatology Associates Of North Alabama, P.C., Huntsville, Alabama, United States

🇺🇸

CHI St. Vincent Medical Group Hot Springs, Hot Springs, Arkansas, United States

and more 88 locations

Combination Chemotherapy and Donor Stem Cell Transplant Followed by Ixazomib Citrate Maintenance Therapy in Treating Patients With Relapsed High-Risk Multiple Myeloma

Phase 1
Completed
Conditions
Recurrent Plasma Cell Myeloma
Plasma Cell Leukemia
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Drug: Ixazomib Citrate
Drug: Melphalan
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Quality-of-Life Assessment
Drug: Tacrolimus
First Posted Date
2015-07-21
Last Posted Date
2020-11-23
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
11
Registration Number
NCT02504359
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Not Applicable
Completed
Conditions
Chronic Myeloid Leukemia
Acute Leukemia
Myelodysplastic Syndrome
Interventions
Procedure: HSCT from MSD
Procedure: HSCT from MUD
Procedure: HSCT from HRD
Drug: Cyclosporin A
Drug: Methotrexate
Drug: Antithymocyte globulin
Drug: Mycophenolate mofetil
First Posted Date
2015-07-01
Last Posted Date
2020-03-05
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
876
Registration Number
NCT02487069
Locations
🇨🇳

Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma

Phase 1
Conditions
Adult Burkitt Lymphoma
MYC Gene Mutation
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Plasmablastic Lymphoma
Interventions
First Posted Date
2015-06-25
Last Posted Date
2022-02-21
Lead Sponsor
Northwestern University
Target Recruit Count
38
Registration Number
NCT02481310
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

and more 2 locations

Safety and Tolerability Study of MBS2320 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Phase 1
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Drug: MBS2320
Drug: Placebo
Drug: Methotrexate
First Posted Date
2015-06-25
Last Posted Date
2017-03-28
Lead Sponsor
Modern Biosciences Ltd
Target Recruit Count
105
Registration Number
NCT02480946
Locations
🇬🇧

Covance Royal Liverpool Clinical Research Unit,Royal Liverpool University Hospital, Liverpool, Merseyside, United Kingdom

🇬🇧

NIHR/Wellcome Trust Imperial Clinical Research Facility (CRF), London, United Kingdom

🇬🇧

Covance Clinical Research Unit Ltd., Leeds, West Yorkshire, United Kingdom

Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease

Phase 2
Conditions
Graft vs Host Disease
Interventions
First Posted Date
2015-06-23
Last Posted Date
2015-06-23
Lead Sponsor
Rabin Medical Center
Target Recruit Count
10
Registration Number
NCT02478424

Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: hrIL-2 active
Drug: hrIL-2 placebo
Drug: MTX
Drug: Folic Acid
Drug: Loxoprofen
First Posted Date
2015-06-10
Last Posted Date
2019-09-09
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
47
Registration Number
NCT02467504
Locations
🇨🇳

Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, Beijing, China

Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors

Phase 1
Completed
Conditions
Brain Tumor, Recurrent
Malignant Neoplasm of Fourth Ventricle of Brain
Interventions
Procedure: Ommaya Reservoir
Drug: Methotrexate
First Posted Date
2015-06-01
Last Posted Date
2019-03-06
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
7
Registration Number
NCT02458339
Locations
🇺🇸

UTHealth & Children's Memorial Hermann Hospital, Houston, Texas, United States

Very Early Versus Delayed Etanercept in Patients With RA

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2015-05-04
Last Posted Date
2019-09-09
Lead Sponsor
University of Leeds
Target Recruit Count
120
Registration Number
NCT02433184
Locations
🇬🇧

Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom

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