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

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

First Posted Date
2016-08-16
Last Posted Date
2024-06-13
Lead Sponsor
Monica Bhatia
Target Recruit Count
24
Registration Number
NCT02867800
Locations
🇺🇸

North Carolina Cancer Hospital, Chapel Hill, North Carolina, United States

🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

and more 4 locations

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

First Posted Date
2016-08-11
Last Posted Date
2018-06-27
Lead Sponsor
Gilead Sciences
Target Recruit Count
15
Registration Number
NCT02862574
Locations
🇺🇸

Albuquerque Center for Rheumatology, Albuquerque, New Mexico, United States

🇺🇸

Omega Research Consultants, LLC, DeBary, Florida, United States

🇺🇸

Stanford University, Palo Alto, California, United States

and more 5 locations

Reduce Risk for Crohn's Disease Patients

First Posted Date
2016-08-02
Last Posted Date
2020-04-16
Lead Sponsor
PIBD-Net
Target Recruit Count
312
Registration Number
NCT02852694
Locations
🇫🇷

Hôpital Necker -Enfants Malades (Service de gastro-enterologie), Paris, France

Unrelated Donor Transplant Versus Immune Therapy in Pediatric Severe Aplastic Anemia

First Posted Date
2016-07-27
Last Posted Date
2023-10-26
Lead Sponsor
Michael Pulsipher, MD
Target Recruit Count
40
Registration Number
NCT02845596
Locations
🇺🇸

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

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

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

and more 10 locations

The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-07-20
Last Posted Date
2023-11-18
Lead Sponsor
Qiang Shu
Target Recruit Count
150
Registration Number
NCT02837978
Locations
🇨🇳

Qilu Hospital, Jinan, Shandong, China

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

First Posted Date
2016-07-14
Last Posted Date
2020-06-12
Lead Sponsor
Genentech, Inc.
Target Recruit Count
578
Registration Number
NCT02833350
Locations
🇺🇸

Pinnacle Research Group; Llc, Central, Anniston, Alabama, United States

🇺🇸

Medvin Clinical Research, Covina, California, United States

🇺🇸

TriWest Research Associates, LLC, El Cajon, California, United States

and more 147 locations

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

First Posted Date
2016-07-13
Last Posted Date
2019-12-04
Lead Sponsor
Pfizer
Target Recruit Count
694
Registration Number
NCT02831855
Locations
🇺🇸

Metroplex Clinical Research Center, Dallas, Texas, United States

🇺🇸

Phase III Clinical Research, Fall River, Massachusetts, United States

🇺🇸

Western Michigan University Homer Stryker MD, Kalamazoo, Michigan, United States

and more 129 locations
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