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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

The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy

Not Applicable
Completed
Conditions
Ectopic Pregnancy
Infertility
Interventions
Procedure: salpingectomy
Drug: Methotrexate
First Posted Date
2016-03-22
Last Posted Date
2016-03-22
Lead Sponsor
Ege University
Target Recruit Count
131
Registration Number
NCT02714998
Locations
🇹🇷

Ege University School of Medicine Department of Obstetrics and Gynecology, Izmir, Turkey

Risk Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)

Phase 2
Active, not recruiting
Conditions
Urothelial Carcinoma of the Bladder
Interventions
Drug: Methotrexate
Drug: Vinblastine
Drug: Doxorubicin
Drug: Cisplatin
Radiation: Intensity modulated radiation therapy (IMRT)
Procedure: Transurethral Resection of Bladder tumor
Drug: 5-FU
Drug: Mitomycin C
First Posted Date
2016-03-17
Last Posted Date
2024-12-24
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
78
Registration Number
NCT02710734
Locations
🇺🇸

Johns Hopkins, Baltimore, Maryland, United States

🇺🇸

Sidney kimmel Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States

and more 1 locations

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo to Methotrexate
Drug: Placebo to Upadacitinib
Drug: Methotrexate
Drug: Upadacitinib
First Posted Date
2016-03-11
Last Posted Date
2023-07-07
Lead Sponsor
AbbVie
Target Recruit Count
1002
Registration Number
NCT02706873
Locations
🇯🇵

Hokkaido University Hospital /ID# 148262, Sapporo, Japan

🇺🇸

TriWest Research Associates- La Mesa /ID# 143738, La Mesa, California, United States

🇺🇸

Desert Medical Advances /ID# 143730, Palm Desert, California, United States

and more 287 locations

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Upadacitinib
Drug: Methotrexate
Drug: Placebo Methotrexate
Drug: Placebo Upadacitinib
First Posted Date
2016-03-11
Last Posted Date
2024-01-30
Lead Sponsor
AbbVie
Target Recruit Count
648
Registration Number
NCT02706951
Locations
🇺🇸

W. Broward Rheum Assoc Inc. /ID# 146010, Tamarac, Florida, United States

🇺🇸

Sarasota Arthritis Center /ID# 146011, Sarasota, Florida, United States

🇺🇸

University of Arizona Cancer Center - North Campus /ID# 147175, Tucson, Arizona, United States

and more 150 locations

Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2016-03-04
Last Posted Date
2020-03-02
Lead Sponsor
Genentech, Inc.
Target Recruit Count
50
Registration Number
NCT02699710
Locations
🇬🇧

Quotient Clinical Ltd, Clinical Research Unit, Nottingham, United Kingdom

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Methotrexate
Drug: Cyclophosphamide
Other: Placebo Cyclophosphamide
Other: Placebo Methotrexate
Other: Placebo Rituximab
Drug: Rituximab
First Posted Date
2016-02-26
Last Posted Date
2016-11-01
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
161
Registration Number
NCT02693210

Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients

Phase 4
Conditions
ph+ Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2016-02-24
Last Posted Date
2016-02-24
Lead Sponsor
Tongji Hospital
Target Recruit Count
40
Registration Number
NCT02690922
Locations
🇨🇳

Tongji hospital, Wuhan, Hubei, China

Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia

First Posted Date
2016-02-23
Last Posted Date
2023-11-02
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
280
Registration Number
NCT02688140
Locations
🇩🇪

OSHO study group, Multiple Locations, Germany

🇩🇪

SAL study group, Multiple Locations, Germany

🇳🇱

HOVON study group, Multiple Locations, Netherlands

and more 5 locations

Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

Phase 4
Completed
Conditions
aGVHD
Interventions
First Posted Date
2016-02-09
Last Posted Date
2022-05-24
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
100
Registration Number
NCT02677181
Locations
🇨🇳

Liping Dou, Beijing, Beijing, China

Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)

Phase 2
Completed
Conditions
Graft Versus Host Disease
Hematopoietic Stem Cell Transplantation
Leukemia
Interventions
First Posted Date
2016-01-26
Last Posted Date
2024-01-23
Lead Sponsor
Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
44
Registration Number
NCT02663622
Locations
🇺🇸

The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

🇺🇸

Ohio State University, Columbus, Ohio, United States

and more 1 locations
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