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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

Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Phase 4
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2005-11-11
Last Posted Date
2011-05-18
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
300
Registration Number
NCT00252668

The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)

Phase 3
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2005-11-10
Last Posted Date
2017-05-10
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
868
Registration Number
NCT00251641

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Phase 1
Completed
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous Condition
Myelodysplastic/Myeloproliferative Neoplasms
Interventions
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: Total Body Irradiation (TBI)
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Phenytoin
Drug: Methotrexate
First Posted Date
2005-10-27
Last Posted Date
2017-09-27
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
147
Registration Number
NCT00245037
Locations
🇺🇸

Knight Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States

Methotrexate in Ankylosing Spondylitis (MTX in AS)

Phase 2
Conditions
Ankylosing Spondylitis
First Posted Date
2005-10-25
Last Posted Date
2005-12-09
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
20
Registration Number
NCT00243750
Locations
🇩🇪

Charité Campus Benjamin-Franklin, Rheumatology, Berlin, Germany

A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2005-10-24
Last Posted Date
2011-10-07
Lead Sponsor
Genentech, Inc.
Target Recruit Count
42
Registration Number
NCT00243412

Rapamycin vs Methotrexate in Diffuse SSc

Phase 1
Completed
Conditions
Systemic Sclerosis
Interventions
First Posted Date
2005-10-18
Last Posted Date
2016-04-11
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
17
Registration Number
NCT00241189
Locations
🇺🇸

Philip Clements, MD, Los Angeles, California, United States

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Phase 3
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2005-10-12
Last Posted Date
2007-08-29
Lead Sponsor
Abbott
Target Recruit Count
128
Registration Number
NCT00235859

Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
Drug: placebo adalimumab, placebo MTX
Drug: adalimumab
Drug: MTX
First Posted Date
2005-10-12
Last Posted Date
2008-07-17
Lead Sponsor
Abbott
Target Recruit Count
271
Registration Number
NCT00235820
Locations
🇺🇸

Global Medical Information-Abbott, Abbott Park, Illinois, United States

Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2005-10-10
Last Posted Date
2007-08-29
Lead Sponsor
Abbott
Target Recruit Count
148
Registration Number
NCT00234845
Locations
🇺🇸

Global Medical Information - Abbott, Abbott Park, Illinois, United States

Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2005-10-10
Last Posted Date
2007-10-03
Lead Sponsor
Abbott
Target Recruit Count
200
Registration Number
NCT00234936
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