MedPath

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

Temsirolimus, Dexamethasone, Mitoxantrone Hydrochloride, Vincristine Sulfate, and Pegaspargase in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Phase 1
Completed
Conditions
Childhood T Acute Lymphoblastic Leukemia
Childhood B Acute Lymphoblastic Leukemia
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Lymphoblastic Lymphoma
Interventions
First Posted Date
2011-07-27
Last Posted Date
2015-07-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
13
Registration Number
NCT01403415
Locations
🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

🇺🇸

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

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

and more 28 locations

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2011-07-22
Last Posted Date
2015-07-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
261
Registration Number
NCT01399697

Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Phase 2
Completed
Conditions
Neurotoxicity
Radiation Toxicity
Chemotherapeutic Agent Toxicity
Cognitive/Functional Effects
Lymphoma
Interventions
Biological: Rituximab
Drug: Cytarabine
Drug: Methotrexate
Drug: Procarbazine
Drug: Vincristine
Radiation: low-dose whole-brain radiation therapy
First Posted Date
2011-07-21
Last Posted Date
2023-07-20
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
91
Registration Number
NCT01399372
Locations
🇺🇸

Fresno Cancer Center, Fresno, California, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 42 locations

Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
First Posted Date
2011-07-13
Last Posted Date
2018-04-17
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
179
Registration Number
NCT01393405
Locations
🇺🇸

University of Iowa, Iowa City, Iowa, United States

🇺🇸

Charlotte Gastroenterology & Hepatology, Charlotte, North Carolina, United States

🇺🇸

Great Lakes Gastroenterology, Mentor, Ohio, United States

and more 28 locations

Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG

Phase 2
Completed
Conditions
Chronic Myelogenous Leukemia
Leukemia
Interventions
Drug: Fludarabine
Drug: Busulfan
Drug: Interleukin-2
Drug: Anti-Thymocyte Globulin
Procedure: Allogeneic related Stem Cell Transplant
Drug: Tacrolimus
Drug: Methotrexate
Drug: G-CSF
First Posted Date
2011-07-11
Last Posted Date
2016-02-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
6
Registration Number
NCT01390402
Locations
🇺🇸

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

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

Phase 1
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Biological: MK-8808
Drug: Methotrexate
Biological: MabThera® (rituximab)
Biological: Rituxan® (rituximab)
Drug: Acetaminophen
Drug: Methylprednisolone
Drug: Loratadine
First Posted Date
2011-07-11
Last Posted Date
2016-07-20
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
100
Registration Number
NCT01390441

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2011-06-27
Last Posted Date
2017-08-01
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
351
Registration Number
NCT01382940
Locations
🇺🇸

Clnical & Translational Reseach Center for Alabama, PC, Tuscaloosa, Alabama, United States

🇺🇸

ArthroCare, Arthritis Care; and Research P.C., Gilbert, Arizona, United States

🇺🇸

Catalina Pointe Rheumatology, Tucson, Arizona, United States

and more 81 locations

Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)

Phase 1
Completed
Conditions
Graft Versus Host Disease
Interventions
Drug: RGI-2001
Drug: Calcineurin Inhibitors
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Conditioning Regimen
Procedure: Allogeneic Bone Marrow Transplantation
Drug: Methotrexate
Drug: Mofetil Mycophenolate
Drug: sirolimus
First Posted Date
2011-06-23
Last Posted Date
2019-10-23
Lead Sponsor
Regimmune Corporation
Target Recruit Count
68
Registration Number
NCT01379209
Locations
🇺🇸

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

🇺🇸

UCSD Moores Cancer Research Institute, San Diego, California, United States

🇺🇸

Stanford School of Medicine, Stanford, California, United States

and more 3 locations

Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years

Not Applicable
Conditions
Acute Lymphoblastic Leukemia Ph Positive
First Posted Date
2011-06-20
Last Posted Date
2022-06-15
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
100
Registration Number
NCT01376427
Locations
🇪🇸

Hospital Germans Trias i Pujol and all Hospital Pethema, Badalona, Barcelona, Spain

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2011-06-14
Last Posted Date
2021-12-06
Lead Sponsor
CSL Behring
Target Recruit Count
418
Registration Number
NCT01373151
Locations
🇺🇸

Clinical Pharmacology Study Group, Worcester, Massachusetts, United States

🇺🇸

Arthritis Associates Of Mississippi, Jackson, Mississippi, United States

🇺🇸

Box Arthritis And Rheumatology Of The Carolinas, Pllc, Charlotte, North Carolina, United States

and more 12 locations
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