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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

Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2014-03-26
Last Posted Date
2015-03-17
Lead Sponsor
medac GmbH
Target Recruit Count
35
Registration Number
NCT02097173
Locations
🇺🇸

Clinical Trials of Texas, Inc., San Antonio, Texas, United States

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2014-03-20
Last Posted Date
2017-03-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
465
Registration Number
NCT02093026

PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

Phase 3
Conditions
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Interventions
First Posted Date
2014-03-13
Last Posted Date
2021-03-15
Lead Sponsor
Huiqiang Huang
Target Recruit Count
264
Registration Number
NCT02085655
Locations
🇨🇳

Department of Medical Oncology, Sun Yat-sen University Cancer Center,, Guangzhou, Guangdong, China

Individualized High Dose Methotrexate to Treat Cancer in Children Who Have a Significant Risk for Side Effects to Methotrexate

Not Applicable
Completed
Conditions
Cancer
Interventions
First Posted Date
2014-03-04
Last Posted Date
2021-02-24
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
23
Registration Number
NCT02076997
Locations
🇺🇸

Texas Children's Hospital, Houston, Texas, United States

Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: F8IL10
Drug: Methotrexate
First Posted Date
2014-03-03
Last Posted Date
2018-05-18
Lead Sponsor
Philogen S.p.A.
Target Recruit Count
36
Registration Number
NCT02076659
Locations
🇮🇹

Azienda Ospedaliera San Camillo-Forlanini Roma, Roma, Italy

🇮🇹

Policlinico San Matteo, Pavia, Pavia, Italy

🇮🇹

Pisa University Hospital, Pisa, Italy

and more 2 locations

RCT of Methotrexate Added to Treatment As Usual in Schizophrenia

Phase 1
Completed
Conditions
Schizoaffective Disorder
Schizophrenia
Schizophreniform Disorder
Interventions
First Posted Date
2014-02-28
Last Posted Date
2015-09-22
Lead Sponsor
Pakistan Institute of Living and Learning
Target Recruit Count
92
Registration Number
NCT02074319
Locations
🇵🇰

Civil hospital Karachi, Karachi, Sindh, Pakistan

🇵🇰

Institute of Behavioural Sciences, Karachi, Sindh, Pakistan

🇵🇰

Karwn e Hayat, Karachi, Sindh, Pakistan

and more 1 locations

Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients

Phase 3
Completed
Conditions
Psoriatic Arthritis
Interventions
First Posted Date
2014-02-19
Last Posted Date
2020-11-13
Lead Sponsor
Instituto de Medicina Molecular João Lobo Antunes
Target Recruit Count
44
Registration Number
NCT02065713
Locations
🇵🇹

Centro Académico de Medicina de Lisboa, Lisbon, Portugal

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
RA
Interventions
Drug: Sarilumab
Device: Auto-Injector Device (AID)
Device: Pre-filled Syringe (PFS)
Drug: Methotrexate
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Hydroxychloroquine
First Posted Date
2014-02-07
Last Posted Date
2017-06-20
Lead Sponsor
Sanofi
Target Recruit Count
217
Registration Number
NCT02057250
Locations
🇨🇱

Investigational Site Number 152050, Santiago, Chile

🇨🇱

Investigational Site Number 152007, Viña Del Mar, Chile

🇲🇽

Investigational Site Number 484005, Monterrey, Mexico

and more 50 locations

A Study of the Combination of Cetuximab and Methotrexate in Recurrent or Metastatic Cancer of the Head and Neck

Phase 1
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
First Posted Date
2014-02-04
Last Posted Date
2021-03-12
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
52
Registration Number
NCT02054442
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

🇳🇱

Medical Centre Haaglanden, Den Haag, Netherlands

🇳🇱

Medical Centre Leeuwarden, Leeuwarden, Netherlands

and more 5 locations

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Tocilizumab
Drug: Methotrexate
Drug: Non-Biologic DMARDs
First Posted Date
2014-01-28
Last Posted Date
2018-04-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
133
Registration Number
NCT02046616
Locations
🇩🇰

Aalborg Universitetshospital Nord, Reumatologisk Afdeling, Alborg, Denmark

🇩🇰

Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme, Hellerup, Denmark

🇩🇰

Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet, Glostrup, Denmark

and more 24 locations
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