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

Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Phase 3
Completed
Conditions
Disorder Related to Bone Marrow Transplantation
Leukemia
Transplantation Infection
Interventions
First Posted Date
2011-11-15
Last Posted Date
2021-12-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
256
Registration Number
NCT01471444
Locations
🇺🇸

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

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2011-11-10
Last Posted Date
2019-09-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
145
Registration Number
NCT01469013
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., Toyama, Japan

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

First Posted Date
2011-10-13
Last Posted Date
2022-06-28
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
23
Registration Number
NCT01451515
Locations
🇺🇸

Rady Children's Hospital San Diego, San Diego, California, United States

🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Continuous Intraventricular Methotrexate in Treating Patients With Leptomeningeal Disease

Not Applicable
Withdrawn
Conditions
Leptomeningeal Metastases
Interventions
Other: pharmacological study
Drug: methotrexate
First Posted Date
2011-09-21
Last Posted Date
2012-11-09
Lead Sponsor
City of Hope Medical Center
Registration Number
NCT01438021

A Clinical Trial in Patients With Breast Cancer Susceptibility Gene (BRCA) Defective Tumours

Phase 2
Completed
Conditions
Breast Cancer
Ovarian Cancer
Interventions
First Posted Date
2011-09-12
Last Posted Date
2019-07-09
Lead Sponsor
University of Oxford
Target Recruit Count
74
Registration Number
NCT01432145
Locations
🇬🇧

Churchill Hospital, Oxford, United Kingdom

Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia

Phase 2
Active, not recruiting
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Complete Remission
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Philadelphia Chromosome Positive
Untreated Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2011-08-29
Last Posted Date
2024-05-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
88
Registration Number
NCT01424982
Locations
🇺🇸

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

S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

First Posted Date
2011-08-09
Last Posted Date
2021-10-29
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
53
Registration Number
NCT01412879
Locations
🇺🇸

Illinois CancerCare - Galesburg, Galesburg, Illinois, United States

🇺🇸

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

🇺🇸

Wenatchee Valley Medical Center, Wenatchee, Washington, United States

and more 200 locations

AC220 for Children With Relapsed/Refractory ALL or AML

Phase 1
Completed
Conditions
Lymphoblastic Leukemia, Acute, Childhood
Myelogenous Leukemia, Acute, Childhood
Interventions
First Posted Date
2011-08-08
Last Posted Date
2022-04-04
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
24
Registration Number
NCT01411267
Locations
🇺🇸

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

🇺🇸

Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina, United States

🇺🇸

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

and more 8 locations

Masitinib in Refractory Active Rheumatoid Arthritis

Phase 2
Terminated
Conditions
Rheumatoid Arthritis (RA)
Interventions
Drug: masitinib 3 mg
Drug: masitinib 6.0 mg
Drug: methotrexate
Drug: Placebo (methotrexate)
Drug: Placebo (masitinib)
First Posted Date
2011-08-05
Last Posted Date
2018-12-17
Lead Sponsor
AB Science
Target Recruit Count
324
Registration Number
NCT01410695
Locations
🇨🇿

ARTMEDI UPD s.r.o, Hostivice, Czechia

Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2011-07-28
Last Posted Date
2014-09-16
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
100
Registration Number
NCT01404429
Locations
🇮🇳

New OPD Block, Rheumatology Clinic, Level 3, Chandigarh, India

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