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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

Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

Phase 1
Completed
Conditions
Lymphoma
Leukemia
Interventions
First Posted Date
2007-07-25
Last Posted Date
2015-04-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
150
Registration Number
NCT00506922
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Neoadjuvant Chemotherapy With Methotrexate, Vinblastine, Adriamycin and Cisplatin (M-VAC) Plus Avastin in Patients With Urothelial Cancer

First Posted Date
2007-07-25
Last Posted Date
2016-03-31
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT00506155
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-07-20
Last Posted Date
2014-08-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
36
Registration Number
NCT00504777

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-07-18
Last Posted Date
2016-10-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
246
Registration Number
NCT00502996

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2007-07-18
Last Posted Date
2017-08-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
10
Registration Number
NCT00502853
Locations
🇮🇹

Università Degli Studi Di Genova - Dimi; Reumatologia, Genova, Liguria, Italy

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

First Posted Date
2007-07-16
Last Posted Date
2024-12-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
160
Registration Number
NCT00501826
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients

Phase 2
Terminated
Conditions
Leukemia
Interventions
Drug: Imatinib Mesylate
Drug: Fludarabine (Fludara)
Drug: Busulfan
Drug: Antithymocyte Globulin (ATG)
Drug: Tacrolimus
Drug: Methotrexate
Procedure: Donor lymphocyte infusion (DLI)
Procedure: Stem Cell Transplant
First Posted Date
2007-07-12
Last Posted Date
2012-04-23
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
42
Registration Number
NCT00499889
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: placebo
Drug: methotrexate
First Posted Date
2007-07-10
Last Posted Date
2015-02-05
Lead Sponsor
Centre Hospitalier Universitaire de Besancon
Target Recruit Count
110
Registration Number
NCT00498589
Locations
🇮🇹

Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Italy

🇮🇹

Istituto Clinico Humanitas, Rozzano , Milano, Italy

🇳🇱

LUMC, Leiden, Netherlands

and more 19 locations

ZD6474 (Zactima) and Metronomic Chemotherapy in Advanced Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2007-07-04
Last Posted Date
2013-11-18
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
25
Registration Number
NCT00496665
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Phase 4
Completed
Conditions
Acute Lymphoblastic Leukemia
First Posted Date
2007-07-02
Last Posted Date
2009-05-19
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
374
Registration Number
NCT00494897
Locations
🇪🇸

Hospital Central de Asturias, Oviedo, Asturias, Spain

🇪🇸

Hospital general de Castellón, Castello, Castellón, Spain

🇪🇸

Hospital Mútua de Terrassa, Terrassa, Barcelona, Spain

and more 83 locations
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