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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

Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo
Drug: Brodalumab
Drug: Methotrexate
Dietary Supplement: folic acid
First Posted Date
2009-08-03
Last Posted Date
2021-12-21
Lead Sponsor
Amgen
Target Recruit Count
252
Registration Number
NCT00950989

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-07-08
Last Posted Date
2014-06-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
15
Registration Number
NCT00934648

Mechanism of Action Study for Psoriasis

Phase 4
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2009-07-03
Last Posted Date
2017-08-31
Lead Sponsor
Tufts Medical Center
Target Recruit Count
33
Registration Number
NCT00932113
Locations
🇺🇸

Tufts Medical Center, Department of Dermatology, Boston, Massachusetts, United States

Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Phase 1
Terminated
Conditions
Relapsed Acute Lymphoblastic Leukemia
Allergy to PEG e.Coli Asparaginase
Allergy to Native e.Coli Asparaginase
Interventions
First Posted Date
2009-06-25
Last Posted Date
2019-02-19
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
1
Registration Number
NCT00928200
Locations
🇺🇸

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

Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

Phase 3
Completed
Conditions
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Interventions
First Posted Date
2009-06-25
Last Posted Date
2019-02-01
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
139
Registration Number
NCT00928018
Locations
🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 2 locations

Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2009-06-22
Last Posted Date
2022-01-19
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
55
Registration Number
NCT00925652
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford, Massachusetts, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 6 locations

A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

Phase 1
Withdrawn
Conditions
Rheumatoid Arthritis
Interventions
Drug: AZD9056
Drug: Methotrexate
First Posted Date
2009-06-15
Last Posted Date
2010-12-03
Lead Sponsor
AstraZeneca
Target Recruit Count
12
Registration Number
NCT00920608

Treosulfan and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Nonmalignant Inherited Disorders

Phase 2
Completed
Conditions
Non-Neoplastic Hematologic and Lymphocytic Disorder
Interventions
Biological: Anti-Thymocyte Globulin
Procedure: Allogeneic Bone Marrow Transplantation
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation
Drug: Tacrolimus
Procedure: Umbilical Cord Blood Transplantation
Drug: Treosulfan
First Posted Date
2009-06-12
Last Posted Date
2021-08-13
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
98
Registration Number
NCT00919503
Locations
🇺🇸

Oregon Health and Science University, Portland, Oregon, United States

🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

🇺🇸

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

and more 3 locations

Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis

Phase 4
Terminated
Conditions
Macular Edema
Sarcoid-associated Uveitis
Ocular Sarcoidosis
Interventions
Drug: Methotrexate
Drug: Placebo
First Posted Date
2009-06-11
Last Posted Date
2014-06-02
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
7
Registration Number
NCT00918554
Locations
🇫🇷

Hôpital Avicenne - Service de Médecine Interne, Bobigny, France

🇫🇷

CHU Michallon de Grenoble, Grenoble, France

Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

Phase 2
Completed
Conditions
Leukemia, Lymphocytic, Acute
Interventions
First Posted Date
2009-05-20
Last Posted Date
2015-06-29
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
37
Registration Number
NCT00905034
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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