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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

A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Phase 3
Terminated
Conditions
Juvenile Idiopathic Arthritis
Interventions
Drug: Placebo
Drug: CNTO 148 (Golimumab)
Drug: Methotrexate
First Posted Date
2010-10-29
Last Posted Date
2016-04-04
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
173
Registration Number
NCT01230827

Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL

First Posted Date
2010-10-26
Last Posted Date
2024-12-11
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Target Recruit Count
745
Registration Number
NCT01228331
Locations
🇩🇪

Universitaetsklinikum Duesseldorf, Duesseldorf, Germany

🇩🇪

University Medical Center Hamburg - Eppendorf, Hamburg, Germany

🇩🇪

Johannes Gutenberg University, Mainz, Germany

and more 11 locations

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: LY2127399
Drug: Placebo Q2W
Drug: Placebo Q4W
Drug: Methotrexate
First Posted Date
2010-09-09
Last Posted Date
2018-05-08
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1041
Registration Number
NCT01198002
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

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Phase 3
Active, not recruiting
Conditions
Ann Arbor Stage I B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Adult B Lymphoblastic Lymphoma
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Down Syndrome
Hypodiploid B Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive
Ann Arbor Stage II B Lymphoblastic Lymphoma
Childhood B Lymphoblastic Lymphoma
Interventions
First Posted Date
2010-08-30
Last Posted Date
2024-02-08
Lead Sponsor
Children's Oncology Group
Target Recruit Count
9350
Registration Number
NCT01190930
Locations
🇺🇸

Valley Children's Hospital, Madera, California, United States

🇺🇸

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

and more 241 locations

Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies

Phase 3
Completed
Conditions
Chronic Myelocytic Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Acute Myelocytic Leukemia
Hodgkin's Disease
Interventions
First Posted Date
2010-08-25
Last Posted Date
2013-03-21
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
6
Registration Number
NCT01188798
Locations
🇺🇸

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

Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

Phase 4
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2010-08-24
Last Posted Date
2010-08-25
Lead Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Target Recruit Count
100
Registration Number
NCT01187264
Locations
🇮🇳

Postgraduate Institute of Medical Education and Research, Chandigarh, U.T, India

Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL

Phase 1
Terminated
Conditions
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma
Interventions
First Posted Date
2010-08-24
Last Posted Date
2022-03-31
Lead Sponsor
South Plains Oncology Consortium
Target Recruit Count
3
Registration Number
NCT01187810
Locations
🇺🇸

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)

Phase 1
Terminated
Conditions
Lymphoblastic Leukemia, Acute
Leukemia, Lymphoblastic, Acute
Lymphoblastic Leukemia, Acute, Childhood
Leukemia, Lymphoblastic, Acute, T Cell
Interventions
First Posted Date
2010-08-23
Last Posted Date
2024-02-01
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
6
Registration Number
NCT01186328
Locations
🇦🇺

Sydney Children's Hospital, Sydney, Australia

🇺🇸

St. Jude, Memphis, Tennessee, United States

🇺🇸

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

and more 4 locations
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