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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

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-09-18
Last Posted Date
2015-05-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
418
Registration Number
NCT00754572

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

Phase 2
Conditions
Wegener's Granulomatosis
Churg-Strauss Syndrome
Microscopic Polyangiitis
Polyarteritis Nodosa
Interventions
First Posted Date
2008-09-12
Last Posted Date
2008-09-12
Lead Sponsor
University of Parma
Registration Number
NCT00751517
Locations
🇮🇹

Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital, Parma, Italy/Parma, Italy

Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

Phase 1
Completed
Conditions
Sarcoma
Interventions
Drug: cisplatin
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: methotrexate
Drug: zoledronic acid
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Biological: filgrastim
Drug: Mesna
First Posted Date
2008-08-28
Last Posted Date
2014-07-04
Lead Sponsor
Children's Oncology Group
Target Recruit Count
24
Registration Number
NCT00742924
Locations
🇺🇸

Childrens Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia, United States

🇺🇸

Maine Children's Cancer Program at Barbara Bush Children's Hospital, Scarborough, Maine, United States

and more 85 locations

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

Not Applicable
Completed
Conditions
Hematologic Malignancies
Interventions
First Posted Date
2008-08-26
Last Posted Date
2020-11-23
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
18
Registration Number
NCT00741455
Locations
🇺🇸

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Pilot Study of MGd + High-dose MTX-Based Chemoimmunotherapy + RT for Newly Dx PCNSL

Early Phase 1
Withdrawn
Conditions
Lymphoma
Neurotoxicity
Brain and Central Nervous System Tumors
First Posted Date
2008-08-14
Last Posted Date
2012-05-18
Lead Sponsor
Northwestern University
Registration Number
NCT00734773

Methotrexate, Glucarpidase, and Leucovorin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Phase 1
Completed
Conditions
Neurotoxicity
Chemotherapeutic Agent Toxicity
Mucositis
Lymphoma
First Posted Date
2008-08-04
Last Posted Date
2014-01-27
Lead Sponsor
University College, London
Target Recruit Count
4
Registration Number
NCT00727831
Locations
🇬🇧

Leeds General Infirmary, Leeds, England, United Kingdom

🇬🇧

Torbay Hospital, Torquay, England, United Kingdom

Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Phase 2
Terminated
Conditions
Graft Versus Host Disease
Interventions
Drug: Visilizumab
Drug: Antithymocyte globulin (ATG)
Drug: Tacrolimus
Drug: Methotrexate
First Posted Date
2008-07-23
Last Posted Date
2014-07-18
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
8
Registration Number
NCT00720629
Locations
🇺🇸

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2
Completed
Conditions
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Interventions
First Posted Date
2008-07-22
Last Posted Date
2020-04-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
63
Registration Number
NCT00720109
Locations
🇺🇸

New York Medical College, Valhalla, New York, United States

🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Valley Children's Hospital, Madera, California, United States

and more 131 locations

A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Drug: CNTO 136 100 mg
Drug: CNTO 136 50 mg
Drug: CNTO 136 25 mg
Drug: Placebo
Drug: Methotrexate
First Posted Date
2008-07-21
Last Posted Date
2018-01-23
Lead Sponsor
Centocor, Inc.
Target Recruit Count
187
Registration Number
NCT00718718

Bucillamine Study of Holding Remission After Infliximab Dose-off

Phase 4
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-07-16
Last Posted Date
2011-01-05
Lead Sponsor
Saitama Medical University
Target Recruit Count
40
Registration Number
NCT00716248
Locations
🇯🇵

Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan

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