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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

Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

First Posted Date
2016-01-21
Last Posted Date
2017-06-19
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
100
Registration Number
NCT02660762
Locations
🇨🇳

Sun Yat-sen University Cancer Center, GuangZhou, Guangdong, China

Comparison Study of Psoriasis Severity Assessment Tools

Phase 4
Completed
Conditions
Psoriasis
Interventions
Drug: Cyclosporine A
Drug: Methotrexate
First Posted Date
2016-01-14
Last Posted Date
2016-04-15
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
34
Registration Number
NCT02655705
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

Phase 3
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: CF101 2 mg
Drug: Placebo
Drug: MTX
Drug: CF101 1 mg
First Posted Date
2016-01-06
Last Posted Date
2020-12-19
Lead Sponsor
Can-Fite BioPharma
Target Recruit Count
244
Registration Number
NCT02647762
Locations
🇷🇸

Can-Fite Investigational Site #215, Niš, Serbia

🇲🇩

Can-Fite Investigational Site #583, Chisinau, Moldova, Republic of

🇷🇴

Can-Fite Investigational Site #553, Bucuresti, Romania

and more 32 locations

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

First Posted Date
2015-12-31
Last Posted Date
2019-10-01
Lead Sponsor
Jawaharlal Institute of Postgraduate Medical Education & Research
Target Recruit Count
186
Registration Number
NCT02644499
Locations
🇮🇳

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry, Pondicherry UT, India

Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

First Posted Date
2015-12-24
Last Posted Date
2022-06-03
Lead Sponsor
Weiguo Lv
Target Recruit Count
214
Registration Number
NCT02639650
Locations
🇨🇳

Weiguo Lv, Hangzhou, Zhejiang, China

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Phase 2
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2015-12-23
Last Posted Date
2019-05-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
508
Registration Number
NCT02638948
Locations
🇺🇸

Precision Research Organization, Miami Lakes, Florida, United States

🇺🇸

Vizae Clinical Trials Management, Pembroke Pines, Florida, United States

🇺🇸

Integral Rheumatology & Immunology Specialists, Plantation, Florida, United States

and more 42 locations

A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment

Phase 3
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: Fumaric Acid Esters
Drug: Ixekizumab
Drug: Methotrexate
First Posted Date
2015-12-18
Last Posted Date
2019-10-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
162
Registration Number
NCT02634801
Locations
🇩🇪

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ulm, Germany

🇩🇪

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Kiel, Germany

MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

Phase 3
Conditions
Extranodal NK/T-cell Lymphoma, Nasal Type
Interventions
First Posted Date
2015-12-16
Last Posted Date
2021-08-25
Lead Sponsor
Ruijin Hospital
Target Recruit Count
256
Registration Number
NCT02631239
Locations
🇨🇳

Ruijin Hospital, Shanghai, Shanghai, China

A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

Phase 3
Recruiting
Conditions
Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
Interventions
Drug: Nilotinib
Drug: Methotrexate
Drug: Aracytine (Ara C)
Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
Drug: Depomedrol
Drug: Dexamethasone
Drug: Vincristine
Drug: Imatinib
Drug: 6 Mercaptopurine (6MP)
First Posted Date
2015-11-20
Last Posted Date
2019-10-21
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
265
Registration Number
NCT02611492
Locations
🇫🇷

Hopital Saint Louis, Paris, France

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