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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 Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo
Drug: JNJ-38518168 (3 mg)
Drug: JNJ-38518168 (10 mg)
Drug: JNJ-38518168 (30 mg)
Drug: Methotrexate
First Posted Date
2012-09-06
Last Posted Date
2019-03-18
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
272
Registration Number
NCT01679951

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia

Phase 2
Withdrawn
Conditions
Blastic Phase Chronic Myelogenous Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
B-cell Adult Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Interventions
First Posted Date
2012-08-21
Last Posted Date
2015-10-30
Lead Sponsor
Mayo Clinic
Registration Number
NCT01670084
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies

Phase 1
Completed
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Interventions
Procedure: Allogeneic Bone Marrow Transplantation
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bendamustine Hydrochloride
Drug: Fludarabine Phosphate
Biological: Inotuzumab Ozogamicin
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Rituximab
Drug: Tacrolimus
First Posted Date
2012-08-14
Last Posted Date
2024-07-23
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
27
Registration Number
NCT01664910
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Methotrexate in Symptomatic Knee Osteoarthritis

Not Applicable
Completed
Conditions
Osteoarthritis
Interventions
Drug: Methotrexate
Drug: Placebo
First Posted Date
2012-08-01
Last Posted Date
2012-08-01
Lead Sponsor
University of Alexandria
Target Recruit Count
88
Registration Number
NCT01654575
Locations
🇪🇬

Faculty of Medicine, University of Alexandria, Alexandria, Egypt

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: MK-8457 100 mg
Drug: Methotrexate
Drug: Dose-match placebo
First Posted Date
2012-07-27
Last Posted Date
2021-07-30
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
56
Registration Number
NCT01651936

Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer

Phase 2
Withdrawn
Conditions
Anterior Urethral Cancer
Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
Posterior Urethral Cancer
Recurrent Bladder Cancer
Recurrent Urethral Cancer
Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
Stage III Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Ureter Cancer
Urethral Cancer Associated With Invasive Bladder Cancer
Interventions
First Posted Date
2012-07-12
Last Posted Date
2014-01-29
Lead Sponsor
University of Southern California
Registration Number
NCT01639521

Methotrexate for Central Serous Chorioretinopathy Treatment Trial

Phase 2
Conditions
Central Serous Chorioretinopathy
Interventions
Drug: Methotrexate
Drug: Delayed treatment
First Posted Date
2012-07-06
Last Posted Date
2012-07-20
Lead Sponsor
Edward Averbukh
Target Recruit Count
20
Registration Number
NCT01633983
Locations
🇮🇱

Hadassah Hebrew Univercity Medical Center, Jerusalem, Israel

Allogeneic Stem Cell Transplant for CLL

Phase 1
Terminated
Conditions
Chronic Lymphocytic Leukemia
Prolymphocytic Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Richter Syndrome
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Busulfan
Drug: Clofarabine
Biological: Filgrastim
Drug: Gemcitabine
Drug: Methotrexate
Drug: Tacrolimus
First Posted Date
2012-06-27
Last Posted Date
2020-02-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
15
Registration Number
NCT01629511
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

Phase 2
Completed
Conditions
Rheumatoid Arthritis (RA)
Interventions
First Posted Date
2012-06-14
Last Posted Date
2014-05-19
Lead Sponsor
Antares Pharma Inc.
Target Recruit Count
49
Registration Number
NCT01618968
Locations
🇺🇸

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

Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Not Applicable
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: methotrexate
Drug: non-steroidal anti-inflammatory drug (NSAID)
Drug: leflunomide
Procedure: Acupuncture
First Posted Date
2012-06-14
Last Posted Date
2023-11-13
Lead Sponsor
Chinese Academy of Sciences
Target Recruit Count
10
Registration Number
NCT01619176
Locations
🇨🇳

Shanghai GuangHua Hospital of integrated traditional and western medicine, Shanghai, Shanghai, China

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