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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

A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2013-12-05
Last Posted Date
2018-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
139
Registration Number
NCT02001987

A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2013-11-26
Last Posted Date
2018-01-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
401
Registration Number
NCT01995201

A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis

Phase 3
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Non-Biologic DMARDs
Drug: Tocilizumab
Drug: Methotrexate
First Posted Date
2013-11-19
Last Posted Date
2017-06-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
150
Registration Number
NCT01987479
Locations
🇳🇱

Gelre Ziekenhuizen; Reumatologie, Apeldoorn, Netherlands

🇳🇱

Antonius Ziekenhuis Sneek; Department of Rheumatology, Sneek, Netherlands

🇳🇱

Amphia ziekenhuis, locatie langendijk, Breda, Netherlands

and more 17 locations

RCT on the Efficacy of Methotrexate for the Prevention of GTD

Phase 3
Completed
Conditions
Hydatidiform Mole
Interventions
Drug: Methotrexate
Drug: Vitamin B Complex
First Posted Date
2013-11-14
Last Posted Date
2020-04-17
Lead Sponsor
University of the Philippines
Target Recruit Count
99
Registration Number
NCT01984099
Locations
🇵🇭

Philippine General Hospital, University of the Philippines Manila, Taft Avenue, Ermita, Manila, Manila, Philippines

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Phase 2
Completed
Conditions
Anaplastic Large Cell Lymphoma, ALK-Positive
Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma
Interventions
First Posted Date
2013-11-08
Last Posted Date
2024-04-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
137
Registration Number
NCT01979536
Locations
🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

🇺🇸

Valley Children's Hospital, Madera, California, United States

🇺🇸

Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States

and more 151 locations

Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia

Phase 2
Active, not recruiting
Conditions
Large Granular Lymphocytes Leukemia
Interventions
First Posted Date
2013-11-05
Last Posted Date
2024-02-14
Lead Sponsor
Rennes University Hospital
Target Recruit Count
166
Registration Number
NCT01976182
Locations
🇫🇷

Hematology Service - CH de la cote basque, Bayonne, France

🇫🇷

Hematology Unit - Hopital Saint Louis, Paris, France

🇫🇷

Hematology Unit CHRU Lille, Lille, France

and more 55 locations

Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Phase 3
Completed
Conditions
Arthritis, Psoriatic
Interventions
First Posted Date
2013-11-05
Last Posted Date
2020-05-21
Lead Sponsor
Pfizer
Target Recruit Count
686
Registration Number
NCT01976364
Locations
🇺🇸

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States

🇧🇪

ZNA Jan Palfijn, Merksem, Belgium

🇧🇷

Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS, Porto Alegre, RS, Brazil

and more 148 locations

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Phase 2
Terminated
Conditions
Epstein Barr Virus Associated Non Hodgkin's Lymphoma
Epstein Barr Virus Associated Hodgkin's Lymphoma
Post-Transplant Lymphoproliferative Disease
Interventions
First Posted Date
2013-10-17
Last Posted Date
2019-09-23
Lead Sponsor
University of Miami
Target Recruit Count
6
Registration Number
NCT01964755
Locations
🇺🇸

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

🇺🇸

University of Miami, Miami, Florida, United States

Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention

Phase 3
Completed
Conditions
Non-Hodgkin Lymphoma
Hodgkins Disease
Acute Biphenotypic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Acute Lymphoblastic Leukemia
Multiple Myeloma
Interventions
First Posted Date
2013-09-27
Last Posted Date
2023-09-11
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
101
Registration Number
NCT01951885
Locations
🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

First Posted Date
2013-09-13
Last Posted Date
2018-11-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
100
Registration Number
NCT01941095
Locations
🇬🇷

Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens, Greece

🇬🇷

Uni Hospital of Ioannina; Rheumatology, Ioannina, Greece

🇬🇷

General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine, Thessaloniki, Greece

and more 7 locations
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