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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

Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Phase 2
Completed
Conditions
Leukemia
Lymphoma
Stem Cell Transplantation
Interventions
First Posted Date
2009-03-06
Last Posted Date
2020-04-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT00857389
Locations
🇺🇸

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

Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-02-25
Last Posted Date
2014-11-02
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
285
Registration Number
NCT00851318

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: LX3305
Drug: LX3305 Placebo
Drug: Methotrexate
First Posted Date
2009-02-19
Last Posted Date
2010-06-03
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
15
Registration Number
NCT00847886
Locations
🇺🇸

Metroplex Clinical Research Center, Dallas, Texas, United States

Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

Phase 2
Terminated
Conditions
Myelodysplastic Syndromes
Lymphoma
Leukemia
Myelodysplastic/Myeloproliferative Diseases
Interventions
Biological: alemtuzumab
Biological: graft-versus-tumor induction therapy
Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
First Posted Date
2009-01-08
Last Posted Date
2013-12-18
Lead Sponsor
Northside Hospital, Inc.
Target Recruit Count
36
Registration Number
NCT00818961
Locations
🇺🇸

Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States

Efficacy of Methotrexate in Myasthenia Gravis

Phase 2
Completed
Conditions
Myasthenia Gravis
Interventions
Drug: Methotrexate
Other: Placebo
First Posted Date
2008-12-24
Last Posted Date
2016-05-26
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
50
Registration Number
NCT00814138
Locations
🇺🇸

University of California-Irvine, Irvine, California, United States

🇺🇸

Penn State College of Medicine, The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

and more 13 locations

Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

Phase 3
Completed
Conditions
Atopic Dermatitis
Interventions
First Posted Date
2008-12-17
Last Posted Date
2013-05-14
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
100
Registration Number
NCT00809172
Locations
🇫🇷

Hospices Civils de Lyon, Lyon, France

A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission

Phase 4
Completed
Conditions
Arthritis, Rheumatoid
Interventions
Biological: adalimumab
Drug: methotrexate
First Posted Date
2008-12-16
Last Posted Date
2013-12-16
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
33
Registration Number
NCT00808509
Locations
🇸🇪

Site Reference ID/Investigator# 14022, Lund, Sweden

🇸🇪

Site Reference ID/Investigator# 20241, Skoevde, Sweden

🇸🇪

Site Reference ID/Investigator# 14023, Malmo, Sweden

and more 5 locations

Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

Phase 2
Completed
Conditions
Bladder Cancer
Muscle-invasive Bladder Cancer
Interventions
First Posted Date
2008-12-16
Last Posted Date
2016-10-24
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
39
Registration Number
NCT00808639
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Lahey Clinic, Burlington, Massachusetts, United States

🇺🇸

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

and more 1 locations

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2008-12-15
Last Posted Date
2020-11-06
Lead Sponsor
Genentech, Inc.
Target Recruit Count
28
Registration Number
NCT00808210
Locations
🇺🇸

Ohio State Univ Med Center, Columbus, Ohio, United States

🇺🇸

Ctr for Inflammatory Disease, Nashville, Tennessee, United States

🇺🇸

Phillip A Waller MD, PA, Houston, Texas, United States

and more 49 locations
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