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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 to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

Phase 3
Completed
Conditions
Early Rheumatoid Arthritis
Interventions
Biological: adalimumab
Drug: methotrexate
First Posted Date
2010-08-19
Last Posted Date
2013-11-15
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
395
Registration Number
NCT01185301
Locations
🇦🇹

Site Reference ID/Investigator# 44928, Graz, Austria

🇵🇱

Site Reference ID/Investigator# 44984, Warsaw, Poland

🇵🇷

Site Reference ID/Investigator# 39692, Vega Baja, Puerto Rico

and more 65 locations

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Drug: LY3009104
Drug: Placebo
Drug: Methotrexate
First Posted Date
2010-08-19
Last Posted Date
2017-06-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
301
Registration Number
NCT01185353
Locations
🇺🇦

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Vinnytsya, Ukraine

A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: Adalimumab
Drug: Methotrexate
First Posted Date
2010-08-19
Last Posted Date
2014-03-18
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
309
Registration Number
NCT01185288
Locations
🇺🇸

Site Reference ID/Investigator# 43049, Danbury, Connecticut, United States

🇵🇷

Site Reference ID/Investigator# 60850, San Juan, Puerto Rico

🇵🇷

Site Reference ID/Investigator# 60851, Vega Baja, Puerto Rico

and more 46 locations

Tandem Auto-Allo Transplant for Lymphoma

Phase 2
Completed
Conditions
Lymphoma, Low-Grade
T-Cell Lymphoma
Diffuse, Large B-Cell, Lymphoma
Mantle-Cell Lymphoma
Chronic Lymphocytic Leukemia
Lymphoma, Small Lymphocytic
Hodgkin's Lymphoma
Interventions
First Posted Date
2010-08-13
Last Posted Date
2017-03-09
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
42
Registration Number
NCT01181271
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma

Phase 2
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Interventions
First Posted Date
2010-08-09
Last Posted Date
2010-08-09
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
13
Registration Number
NCT01177371
Locations
🇺🇸

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2010-07-30
Last Posted Date
2019-01-22
Lead Sponsor
P. Verschueren
Target Recruit Count
400
Registration Number
NCT01172639
Locations
🇧🇪

Reuma instituut Hasselt, Hasselt, Belgium

🇧🇪

ZNA Jan Palfijn, Merksem, Belgium

🇧🇪

Henri Serruys ziekenhuis, Oostende, Belgium

and more 14 locations

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Adult Acute Monoblastic Leukemia
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
Secondary Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Minimal Differentiation
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Azacitidine
Drug: Busulfan
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Other: Pharmacological Study
Drug: Tacrolimus
First Posted Date
2010-07-23
Last Posted Date
2022-08-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
68
Registration Number
NCT01168219
Locations
🇺🇸

Northwell Health NCORP, Lake Success, New York, United States

🇺🇸

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

🇺🇸

Mount Sinai Hospital, New York, New York, United States

and more 14 locations

A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: tocilizumab
Drug: methotrexate
Biological: 23-Valent Pneumococcal Polysaccharide Vaccine
Biological: Tetanus Toxoid Adsorbed Vaccine
First Posted Date
2010-07-16
Last Posted Date
2012-12-07
Lead Sponsor
Genentech, Inc.
Target Recruit Count
91
Registration Number
NCT01163747

A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
Biological: adalimumab
Drug: Methotrexate
First Posted Date
2010-07-14
Last Posted Date
2016-11-01
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
77
Registration Number
NCT01162421

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Phase 2
Terminated
Conditions
Minimal Residual Disease
Leukemia, Lymphoblastic, Acute
Leukemia, Myelogenous, Acute
Interventions
First Posted Date
2010-07-08
Last Posted Date
2021-10-26
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
2
Registration Number
NCT01158885
Locations
🇺🇸

Seattle Children's Hospital, Seattle, Washington, United States

🇺🇸

Carolina-Levine Children's Hospital, Charlotte, North Carolina, United States

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