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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

Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

Phase 1
Completed
Conditions
Contiguous Stage II Adult Lymphoblastic Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2014-11-18
Last Posted Date
2022-03-10
Lead Sponsor
Mehrdad Abedi, MD
Target Recruit Count
10
Registration Number
NCT02293109
Locations
🇺🇸

University of California Davis, Sacramento, California, United States

Low Dose Metronomic Poly-chemotherapy for Metastatic CRC

Phase 2
Completed
Conditions
Colorectal Cancer
Interventions
First Posted Date
2014-10-31
Last Posted Date
2020-02-12
Lead Sponsor
HaEmek Medical Center, Israel
Target Recruit Count
45
Registration Number
NCT02280694
Locations
🇮🇱

Gastrointestinal Oncology Unit, Institute of Oncology, Davidoff Center, Rabin Medical Center, Belinson Campus,, Petach Tiqva, Israel

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Phase 4
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2014-10-27
Last Posted Date
2014-10-27
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Target Recruit Count
240
Registration Number
NCT02275299
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: F8IL10
Drug: MTX
Drug: Placebo
First Posted Date
2014-10-21
Last Posted Date
2023-06-12
Lead Sponsor
Philogen S.p.A.
Target Recruit Count
27
Registration Number
NCT02270632
Locations
🇨🇭

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

🇨🇭

HFR Fribourg - Hôpital Cantonal, Fribourg, Switzerland

🇩🇪

Universitatsklinikum Freiburg, Freiburg, Germany

and more 5 locations

Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

Phase 4
Completed
Conditions
Crohn's Disease
Interventions
First Posted Date
2014-10-21
Last Posted Date
2018-10-18
Lead Sponsor
Prof. Arie Levine
Target Recruit Count
22
Registration Number
NCT02269358
Locations
🇮🇱

The E. Wolfson.Medical Center, Holon, Israel

JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis

Phase 2
Active, not recruiting
Conditions
Secondary Myelofibrosis
Primary Myelofibrosis
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Drug: Methotrexate
Drug: Mycophenolate Mofetil
Drug: Ruxolitinib
Drug: Tacrolimus
Radiation: Total-Body Irradiation
Procedure: Umbilical Cord Blood Transplantation
First Posted Date
2014-09-29
Last Posted Date
2024-03-05
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
61
Registration Number
NCT02251821
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

Phase 3
Completed
Conditions
Head and Neck Squamous Cell Cancer
Interventions
Drug: Methotrexate
Biological: Pembrolizumab
Drug: Docetaxel
Biological: Cetuximab
First Posted Date
2014-09-29
Last Posted Date
2023-07-17
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
495
Registration Number
NCT02252042

Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.

Phase 4
Conditions
Severe Plaque Type Psoriasis
Interventions
First Posted Date
2014-09-25
Last Posted Date
2014-09-25
Lead Sponsor
Narayana Medical College & Hospital
Target Recruit Count
50
Registration Number
NCT02248792
Locations
🇮🇳

Narayana Med College and Hospital, Nellore, AP, India

Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults

Phase 1
Completed
Conditions
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
B-cell Adult Acute Lymphoblastic Leukemia
T-cell Adult Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2014-08-29
Last Posted Date
2019-11-26
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
19
Registration Number
NCT02228772
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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