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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

Study of Methotrexate in Lupus Erythematosus

Phase 3
Completed
Conditions
Systemic Lupus Erythematosus
First Posted Date
2007-05-07
Last Posted Date
2007-05-07
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
86
Registration Number
NCT00470522
Locations
🇨🇦

University Health Network, Toronto, Ontario, Canada

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: MabThera/Rituxan
Drug: Methotrexate
Other: Placebo
First Posted Date
2007-05-02
Last Posted Date
2016-10-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
520
Registration Number
NCT00468546

Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma

Not Applicable
Completed
Conditions
Brain and Central Nervous System Tumors
First Posted Date
2007-04-19
Last Posted Date
2013-06-24
Lead Sponsor
New Approaches to Brain Tumor Therapy Consortium
Target Recruit Count
12
Registration Number
NCT00463008

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

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: rituximab
Drug: Methotrexate
Drug: Corticosteroid or NSAID
Dietary Supplement: Folate
First Posted Date
2007-04-19
Last Posted Date
2014-11-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
40
Registration Number
NCT00462345

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

Phase 2
Completed
Conditions
Leukemia
First Posted Date
2007-04-11
Last Posted Date
2019-02-15
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
470
Registration Number
NCT00458848
Locations
🇮🇹

Ospedale S. Donato, Arezzo, Italy

🇮🇹

S.G. Moscati Hospital, Avellino, Italy

🇮🇹

Ospedale Binaghi, Cagliari, Italy

and more 63 locations

Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H

Phase 1
Completed
Conditions
Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
First Posted Date
2007-04-10
Last Posted Date
2008-11-18
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
10
Registration Number
NCT00458250
Locations
🇮🇷

Hematology-Oncology & BMT Research Center, Tehran, Iran, Islamic Republic of

a Phase II Study in Primary Central Nervous System Lymphoma

Phase 2
Conditions
Primary Central Nervous System Lymphoma
First Posted Date
2007-04-03
Last Posted Date
2007-04-04
Lead Sponsor
National Health Research Institutes, Taiwan
Target Recruit Count
25
Registration Number
NCT00455286
Locations
🇨🇳

Changhua Christian Hospital, Changhua, Taiwan

🇨🇳

China Medical University Hospital, Taichung, Taiwan

🇨🇳

National Cheng Kung University Hospital, TaiNan, Taiwan

and more 1 locations

Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

Phase 2
Terminated
Conditions
Leukemia
Graft Versus Host Disease
Myelodysplastic Syndromes
First Posted Date
2007-03-22
Last Posted Date
2017-05-24
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
1
Registration Number
NCT00450983
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

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

R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma

First Posted Date
2007-03-22
Last Posted Date
2015-11-10
Lead Sponsor
University of Miami
Target Recruit Count
22
Registration Number
NCT00450801
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

Phase 2
Completed
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions
Biological: sargramostim
Biological: anti-thymocyte globulin
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2007-03-16
Last Posted Date
2017-05-30
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
71
Registration Number
NCT00448201
Locations
🇺🇸

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

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