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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

SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-11-10
Last Posted Date
2012-03-01
Lead Sponsor
4SC AG
Target Recruit Count
266
Registration Number
NCT01010581
Locations
🇧🇬

UMHAT "Sveti Ivan Rilski", Sofia, Bulgaria

🇵🇱

Śląskie Centrum Osteoporozy, Katowice, Poland

🇵🇱

Wojewódzki Szpital Reumatologiczny, Sopot, Poland

and more 24 locations

To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

Phase 1
Completed
Conditions
Arthritis
Rheumatoid Arthritis
Interventions
Biological: CDP6038
Drug: CDP 6038 SC
Other: Placebo IV
Other: Placebo SC
Drug: Methotrexate
First Posted Date
2009-11-06
Last Posted Date
2024-11-15
Lead Sponsor
UCB Pharma
Target Recruit Count
40
Registration Number
NCT01009242

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

First Posted Date
2009-11-04
Last Posted Date
2017-07-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1162
Registration Number
NCT01007435
Locations
🇺🇸

Wenatchee Valley Hospital & Clinics, Wenatchee, Washington, United States

🇦🇺

Royal Prince Alfred Hospital; Rheumatology, Camperdown, New South Wales, Australia

🇺🇸

Ohio State University; Dept of Immunology, Columbus, Ohio, United States

and more 233 locations

Combination Chemotherapy in Treating Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Phase 2
Conditions
Leukemia
First Posted Date
2009-11-01
Last Posted Date
2014-01-10
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
180
Registration Number
NCT01005758

Pegaspargase and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

First Posted Date
2009-11-01
Last Posted Date
2023-01-06
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
11
Registration Number
NCT01005914
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2009-10-26
Last Posted Date
2013-08-12
Lead Sponsor
Amgen
Target Recruit Count
478
Registration Number
NCT01001208

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2009-10-23
Last Posted Date
2017-08-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT01000610
Locations
🇹🇳

Hopital Farhat Hached; Service Rhumatologie, Sousse, Tunisia

🇹🇳

Hopital La Rabta; Service Rhumatologie, Tunis, Tunisia

🇹🇳

Hopital Charles Nicole; Service Rhumatologie, Tunis, Tunisia

and more 1 locations

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo of CDP870
Drug: CDP870 200mg
Drug: Methotrexate
First Posted Date
2009-10-12
Last Posted Date
2012-09-27
Lead Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
Target Recruit Count
127
Registration Number
NCT00993317
Locations
🇰🇷

Seoul national univeristy, Seoul, Korea, Republic of

🇰🇷

Catholic University of Korea ST.Mary's Hospital, Seoul, Korea, Republic of

🇰🇷

Catholic University Hospital of Daegu, Daegu, Korea, Republic of

and more 12 locations

Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

Completed
Conditions
Leukemia
Renal Toxicity
First Posted Date
2009-10-12
Last Posted Date
2017-04-10
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
10
Registration Number
NCT00993135
Locations
🇺🇸

Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer

Phase 2
Completed
Conditions
Recurrent Breast Cancer
Tumors Metastatic to Brain
Stage IV Breast Cancer
Central Nervous System Metastases
Leptomeningeal Metastases
Interventions
Drug: methotrexate
Drug: liposomal cytarabine
Other: quality-of-life assessment
Other: laboratory biomarker analysis
First Posted Date
2009-10-09
Last Posted Date
2017-07-07
Lead Sponsor
University of Washington
Target Recruit Count
3
Registration Number
NCT00992602
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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