Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

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

Clinical Trials

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: Methotrexate
Drug: Non-Biologic DMARDs

First Posted Date: 2014-01-28

Last Posted Date: 2018-04-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 133

Registration Number: NCT02046616

Locations: 🇩🇰
Aalborg Universitetshospital Nord, Reumatologisk Afdeling, Alborg, Denmark
🇩🇰
Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme, Hellerup, Denmark
🇩🇰
Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet, Glostrup, Denmark

and more 24 locations

A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Tocilizumab
Drug: DMARDs
Drug: Oral Corticosteroids
Drug: Methotrexate

First Posted Date: 2014-01-28

Last Posted Date: 2018-12-07

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 162

Registration Number: NCT02046603

Locations: 🇬🇧
Aberdeen Royal Infirmary, Aberdeen, United Kingdom
🇬🇧
Royal Sussex County Hospital; Clinical Investigation Research Unit, Brighton, United Kingdom
🇬🇧
University Hospital of Wales; Dept of Rhematology, Cardiff, United Kingdom

and more 35 locations

Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic Lymphoma

Phase 2

Terminated

Conditions: Acute Lymphocytic Leukemia
Adult Lymphoblastic Lymphoma

Interventions: Drug: DNR
Drug: VCR
Drug: PEG-asp
Drug: CTX
Drug: Prednisone
Drug: Liposomal AraC
Drug: MTX
Drug: LCV
Drug: AraC
Drug: Etoposide
Drug: Dasatinib
Drug: Rituximab
Drug: Hydrocortisone

First Posted Date: 2014-01-23

Last Posted Date: 2022-05-02

Lead Sponsor: University of California, San Diego

Target Recruit Count: 31

Registration Number: NCT02043587

Locations: 🇺🇸
UCSD, Division of Blood and Marrow Transplantation, Moores Cancer Center, La Jolla, California, United States
🇺🇸
Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 1 locations

The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

Phase 3

Completed

Conditions: ALOPECIA AREATA

Interventions: Drug: Methotrexate
Drug: Placebo

First Posted Date: 2014-01-15

Last Posted Date: 2018-05-29

Lead Sponsor: University Hospital, Rouen

Target Recruit Count: 90

Registration Number: NCT02037191

Locations: 🇫🇷
Head Dermatology Department, Rouen, Haute Normandie, France
🇫🇷
CHU de Rouen - Hôpitaux de Rouen, Rouen, Seine Maritime, France

The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Fang yi qing feng shi granule
Drug: placebo
Drug: Methotrexate
Drug: Acetaminophen tablets

First Posted Date: 2014-01-08

Last Posted Date: 2015-10-09

Lead Sponsor: Maoxiang Group Jilin Pharmaceutical Co., Ltd.

Target Recruit Count: 240

Registration Number: NCT02029599

Locations: 🇨🇳
Hubei provincial hospital of tcm, Wuhan, Hubei, China
🇨🇳
Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning, China
🇨🇳
First Teaching hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, China

and more 2 locations

Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays?

Phase 2

Terminated

Conditions: Osteosarcoma
Spindle Cell Sarcoma of Bone

Interventions: Drug: Methotrexate
Drug: Glucarpidase
Drug: Folinic Acid

First Posted Date: 2013-12-27

Last Posted Date: 2015-06-04

Lead Sponsor: University College, London

Target Recruit Count: 34

Registration Number: NCT02022358

Locations: 🇬🇧
University College Hospital, London, United Kingdom

Clinical Guidelines for APL Treatment

Phase 4

Conditions: APL

Interventions: Drug: Atra
Drug: Idarubicin
Drug: methotrexate

First Posted Date: 2013-12-24

Last Posted Date: 2021-03-23

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 200

Registration Number: NCT02020161

Locations: 🇪🇸
Hospital La Fe, Valencia, Spain

Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma

Phase 2

Completed

Conditions: Medulloblastoma With Extensive Nodularity
Medulloblastoma
Nevoid Basal Cell Carcinoma Syndrome
Desmoplastic/Nodular Medulloblastoma

Interventions: Drug: Carboplatin
Other: Cognitive Assessment
Drug: Cyclophosphamide
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Drug: Vincristine Sulfate

First Posted Date: 2013-12-23

Last Posted Date: 2023-01-09

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 26

Registration Number: NCT02017964

Locations: 🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸
UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

and more 170 locations

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: rituximab [MabThera/Rituxan]
Drug: methotrexate
Drug: methylprednisolone

First Posted Date: 2013-12-10

Last Posted Date: 2017-08-21

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 15

Registration Number: NCT02006706

Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia

Phase 3

Active, not recruiting

Conditions: Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Biospecimen Collection
Biological: Blinatumomab
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide
Drug: Leucovorin Calcium
Procedure: Lumbar Puncture
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Biological: Rituximab
Drug: Vincristine
Drug: Vincristine Sulfate
Procedure: X-Ray Imaging

First Posted Date: 2013-12-06

Last Posted Date: 2024-12-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 488

Registration Number: NCT02003222

Locations: 🇺🇸
Banner North Colorado Medical Center, Greeley, Colorado, United States
🇺🇸
Good Samaritan Hospital - Cancer Centers of Colorado, Lafayette, Colorado, United States
🇺🇸
Banner McKee Medical Center, Loveland, Colorado, United States

and more 545 locations

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