Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

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

Clinical Trials

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

Phase 2

Active, not recruiting

Conditions: Malignant Pleural Mesothelioma
Mesothelioma

Interventions: Drug: Cisplatin
Drug: Methotrexate
Drug: Gemcitabine
Other: Lung Cancer Symptom Scale for Mesothelioma Questionnaire

First Posted Date: 2015-11-20

Last Posted Date: 2024-11-28

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 34

Registration Number: NCT02611037

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Methotrexate
Drug: Tocilizumab

First Posted Date: 2015-11-18

Last Posted Date: 2020-02-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 291

Registration Number: NCT02608112

Locations: 🇫🇷
Hopital Jean Minjoz, Besancon, France
🇫🇷
CH de Saint Quentin, Saint Quentin, France
🇫🇷
Cabinet de Rhumatologie MSP de Beaublanc, Limoges, France

and more 67 locations

Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

Phase 4

Conditions: Meningeal Carcinomatosis

Interventions: Drug: methotrexate

First Posted Date: 2015-10-29

Last Posted Date: 2016-10-28

Lead Sponsor: Hui Bu

Target Recruit Count: 50

Registration Number: NCT02590510

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Abatacept
Drug: Methotrexate
Drug: Adalimumab

First Posted Date: 2015-09-23

Last Posted Date: 2020-09-03

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 80

Registration Number: NCT02557100

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇲🇽
Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara, Jalisco, Mexico
🇲🇽
Clinica Integral en Osteoporosis y Artritis CLINOSAR Mexico S.A. de C.V., Mexico D.F., Mexico

and more 24 locations

Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe

Phase 3

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Methotrexate

First Posted Date: 2015-09-17

Last Posted Date: 2017-10-06

Lead Sponsor: Nordic Pharma SAS

Target Recruit Count: 278

Registration Number: NCT02553018

Locations: 🇫🇷
SARAUX, Brest, France
🇫🇷
HUDRY, Paris, France

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Phase 1

Active, not recruiting

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: ITMHA
Drug: Dexamethasone
Drug: Mitoxantrone
Drug: Pegaspargase
Drug: Asparaginase Erwinia Chrysanthemi
Drug: Bortezomib
Drug: Vorinostat
Drug: Cyclophosphamide
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Leucovorin Calcium
Drug: Cytarabine
Drug: Etoposide
Drug: Vincristine

First Posted Date: 2015-09-17

Last Posted Date: 2024-01-18

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 50

Registration Number: NCT02553460

Locations: 🇺🇸
Children's Hospital of Orange County, Orange, California, United States
🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Rady Children's Hospital and Health Center, San Diego, California, United States

and more 14 locations