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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

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

Not Applicable
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2012-06-12
Last Posted Date
2012-06-14
Lead Sponsor
Shanxi Medical University
Target Recruit Count
500
Registration Number
NCT01617590
Locations
🇨🇳

rheumatism department,Second hospital of Shanxi medical university, TaiYuan, Shanxi, China

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

Phase 1
Completed
Conditions
Lymphoblastic Leukemia, Acute, Childhood
Peripheral T-cell Lymphoma
Lymphoblastic Lymphoma
Interventions
First Posted Date
2012-06-07
Last Posted Date
2023-07-27
Lead Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Target Recruit Count
16
Registration Number
NCT01614197
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

Lurie Children's Hospital, Chicago, Illinois, United States

and more 29 locations

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2012-06-06
Last Posted Date
2013-08-05
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
201
Registration Number
NCT01613079
Locations
🇨🇳

Deptment of Rheumatology, Peking Union Medical College Hospital, Beijing, Beijing, China

Cardiovascular Inflammation Reduction Trial

Phase 3
Completed
Conditions
Cardiovascular Disease
Interventions
Drug: Placebo
Drug: Methotrexate
First Posted Date
2012-05-09
Last Posted Date
2020-07-24
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
4786
Registration Number
NCT01594333
Locations
🇺🇸

Team Medical Research, Miami, Florida, United States

🇺🇸

Indiana Heart Physicians, Indianapolis, Indiana, United States

🇺🇸

Sanitas Research, Miami, Florida, United States

and more 455 locations

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2012-04-30
Last Posted Date
2015-07-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
77
Registration Number
NCT01587989

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)

Phase 3
Completed
Conditions
Primary Cutaneous Anaplastic Large Cell Lymphoma
Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Interventions
First Posted Date
2012-04-17
Last Posted Date
2021-01-05
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
131
Registration Number
NCT01578499

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning

Phase 2
Completed
Conditions
Acute Myeloid Leukemia
Non-Hodgkins Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Leukemia
Myeloproliferative Diseases
Acute Lymphocytic Leukemia
Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Hodgkins Lymphoma
Interventions
First Posted Date
2012-04-06
Last Posted Date
2023-06-29
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
201
Registration Number
NCT01572662
Locations
🇺🇸

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

Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

Phase 2
Terminated
Conditions
Rheumatoid Arthritis (RA)
Interventions
Drug: MK-8457 100 mg
Drug: Dose-Matched Placebo
Drug: Methotrexate
First Posted Date
2012-04-02
Last Posted Date
2019-03-27
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
82
Registration Number
NCT01569152

Good EULAR Response In Patients With Early Rheumatoid Arthritis

Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2012-03-20
Last Posted Date
2016-11-11
Lead Sponsor
Pfizer
Target Recruit Count
76
Registration Number
NCT01558089
Locations
🇬🇷

G. Papanikolaoy, Thessaloniki, Exochi, Greece

🇬🇷

"Olympion therapeutic center" General Clinic of Patras, Patras, Greece

🇬🇷

424 Military Hospital, Thessaloniki, Thessalonikis, Greece

and more 6 locations

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Phase 2
Completed
Conditions
Arthritis, Rheumatoid
Interventions
First Posted Date
2012-03-15
Last Posted Date
2024-10-21
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
379
Registration Number
NCT01554696
Locations
🇺🇸

University of California San Diego, La Jolla, California, United States

🇺🇸

The Center for Rheumatology and Bone Research, Wheaton, Maryland, United States

🇧🇪

Hospital Erasme, Brussels, Belgium

and more 46 locations
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