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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

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen

Phase 1
Completed
Conditions
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Chronic Myeloproliferative Disorders
Lymphoma
Myelodysplastic Syndromes
Interventions
Biological: rabbit anti-thymocyte globulin (ATG)
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: methotrexate
First Posted Date
2007-03-16
Last Posted Date
2017-07-17
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
54
Registration Number
NCT00448357
Locations
🇺🇸

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

Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

Phase 1
Completed
Conditions
Arthritis, Rheumatoid
First Posted Date
2007-03-13
Last Posted Date
2011-05-23
Lead Sponsor
Pfizer
Target Recruit Count
20
Registration Number
NCT00446784
Locations
🇺🇸

Pfizer Investigational Site, Ducansville, Pennsylvania, United States

Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Not Applicable
Completed
Conditions
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Childhood Acute Myeloid Leukemia in Remission
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Interventions
Drug: cyclophosphamide
Drug: busulfan
Drug: tacrolimus
Drug: methotrexate
Genetic: cytogenetic analysis
Other: flow cytometry
Other: pharmacological study
Other: pharmacogenomic studies
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
First Posted Date
2007-03-09
Last Posted Date
2018-01-02
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
52
Registration Number
NCT00445744
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Phase 3
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2007-03-09
Last Posted Date
2011-08-15
Lead Sponsor
Pfizer
Target Recruit Count
550
Registration Number
NCT00445770
Locations
🇯🇵

Pfizer Investigational Site, Toyama, Japan

Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Phase 4
Completed
Conditions
Juvenile Chronic Polyarthritis
Juvenile Idiopathic Arthritis
Juvenile Rheumatoid Arthritis
Interventions
First Posted Date
2007-03-06
Last Posted Date
2013-05-31
Lead Sponsor
Seattle Children's Hospital
Target Recruit Count
85
Registration Number
NCT00443430
Locations
🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

Children's Hospital at Montefiore, Bronx, New York, United States

🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

and more 12 locations

Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Not Applicable
Completed
Conditions
Fasciitis
First Posted Date
2007-03-01
Last Posted Date
2011-08-11
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
6
Registration Number
NCT00441961
Locations
🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

Phase 1
Completed
Conditions
Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2007-02-27
Last Posted Date
2020-02-19
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
31
Registration Number
NCT00440726
Locations
🇨🇦

Sick Kids, Toronto, Ontario, Canada

🇺🇸

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

🇺🇸

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 21 locations

Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis

Phase 3
Completed
Conditions
Ankylosing Spondylitis
First Posted Date
2007-02-23
Last Posted Date
2007-02-27
Lead Sponsor
Association de Recherche Clinique en Rhumatologie
Target Recruit Count
240
Registration Number
NCT00439283
Locations
🇫🇷

CHU Amiens, Amiens, France

🇫🇷

CHU Hôpital Minjoz, Besançon, France

🇫🇷

Hôpital Gilles de Corbeil, Corbeil Essonnes, France

and more 28 locations

ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Phase 1
Terminated
Conditions
Recurrent Pediatric ALL
Acute Lymphoblastic Leukemia
Refractory Pediatric ALL
Relapsed Pediatric ALL
Interventions
First Posted Date
2007-02-23
Last Posted Date
2021-03-17
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
9
Registration Number
NCT00439296
Locations
🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

🇺🇸

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

🇺🇸

C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States

and more 2 locations

Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant

Phase 2
Completed
Conditions
CD20 Positive
Hematopoietic and Lymphoid Cell Neoplasm
Lymphocytic Neoplasm
Lymphoma
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bortezomib
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Biological: Filgrastim
Drug: Melphalan
Drug: Methotrexate
Biological: Rituximab
Drug: Tacrolimus
First Posted Date
2007-02-23
Last Posted Date
2019-09-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
40
Registration Number
NCT00439556
Locations
🇺🇸

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

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