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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

Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Phase 4
Terminated
Conditions
Rheumatoid Arthritis
First Posted Date
2005-10-06
Last Posted Date
2007-04-24
Lead Sponsor
Abbott
Target Recruit Count
160
Registration Number
NCT00233558
Locations
🇺🇸

Global Medical Information - Abbott, North Chicago, Illinois, United States

Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)

Phase 2
Withdrawn
Conditions
Systemic Lupus Erythematosus
Interventions
Procedure: Plasmapheresis
Procedure: Leukapheresis
Drug: Rabbit anti-thymocyte globulin
Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT)
Procedure: Autologous CD34+HPC transplantation (HSCT)
Drug: Methylprednisolone
Drug: Growth colony stimulating factor (G-CSF)
Drug: Corticosteroids
Drug: Mycophenolate mofetil
Drug: Azathioprine
Drug: Intravenous immunoglobulin
Drug: Methotrexate
Drug: Rituximab
Drug: Leflunomide
First Posted Date
2005-09-30
Last Posted Date
2013-02-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00230035
Locations
🇺🇸

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

🇺🇸

UCSD, Thornton Hospital, La Jolla, California, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

and more 2 locations

Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis

Phase 2
Completed
Conditions
Intraluminal Pulmonary Vein Stenosis
Interventions
First Posted Date
2005-09-22
Last Posted Date
2011-06-27
Lead Sponsor
Boston Children's Hospital
Target Recruit Count
28
Registration Number
NCT00215046
Locations
🇺🇸

Children's Hospital Boston, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2005-09-21
Last Posted Date
2005-09-21
Lead Sponsor
Hvidovre University Hospital
Target Recruit Count
160
Registration Number
NCT00209859
Locations
🇩🇰

Hvidovre University Hospital, Hvidovre, Denmark

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-09-21
Last Posted Date
2012-10-18
Lead Sponsor
Centocor, Inc.
Target Recruit Count
172
Registration Number
NCT00207714

Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

Phase 3
Completed
Conditions
Squamous Cell Carcinoma of the Head and Neck
First Posted Date
2005-09-21
Last Posted Date
2011-01-27
Lead Sponsor
AstraZeneca
Target Recruit Count
477
Registration Number
NCT00206219
Locations
🇬🇧

Research Site, London, United Kingdom

Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

Phase 3
Completed
Conditions
Early Rheumatoid Arthritis
Interventions
Biological: Adalimumab
Drug: Methotrexate placebo
Drug: Methotrexate
Biological: Adalimumab placebo
First Posted Date
2005-09-20
Last Posted Date
2013-07-12
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
799
Registration Number
NCT00195663
Locations
🇺🇸

Site Reference ID/Investigator# 2491, Los Angeles, California, United States

🇺🇸

Site Reference ID/Investigator# 762, Aventura, Florida, United States

🇺🇸

Site Ref # / Investigator 95960, Hagerstown, Maryland, United States

and more 120 locations

German Multicenter Trial for the Treatment of Newly Diagnosed T-lymphoblastic Lymphoma in Adults

Phase 4
Completed
Conditions
Lymphoma, Lymphoblastic
First Posted Date
2005-09-20
Last Posted Date
2010-08-23
Lead Sponsor
Johann Wolfgang Goethe University Hospital
Target Recruit Count
75
Registration Number
NCT00199017
Locations
🇩🇪

University Hospital, Medical Dept. II, Frankfurt, Germany

German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)

First Posted Date
2005-09-20
Last Posted Date
2022-08-18
Lead Sponsor
Goethe University
Target Recruit Count
1883
Registration Number
NCT00198991
Locations
🇩🇪

University of Frankfurt, Medical Dept. II, Frankfurt, Germany

A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

Phase 3
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Other: Placebo
Biological: Infliximab
Drug: MTX
First Posted Date
2005-09-20
Last Posted Date
2017-03-24
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
143
Registration Number
NCT00202852
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