Methotrexate

Generic Name: Methotrexate

Brand Names: Metoject, Nordimet, Otrexup, Rasuvo, Reditrex, Trexall, Xatmep, Jylamvo

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₅

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

Clinical Trials

Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft vs Host Disease Following Unrelated Stem Cell Transplant

Phase 2

Completed

Conditions: Graft vs Host Disease
Hematologic Neoplasms
Non-Neoplastic Hematologic and Lymphocytic Disorder

Interventions: Drug: Vorinostat
Drug: Tacrolimus
Drug: Methotrexate

First Posted Date: 2013-02-13

Last Posted Date: 2018-08-13

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 26

Registration Number: NCT01790568

Locations: 🇺🇸
University of Michigan Cancer Center, Ann Arbor, Michigan, United States

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Contiguous Stage II Grade 2 Follicular Lymphoma
Adult Acute Myeloid Leukemia With Del(5q)

Interventions: Drug: vorinostat
Drug: tacrolimus
Drug: cyclosporine
Drug: methotrexate
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2013-02-12

Last Posted Date: 2018-07-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT01789255

Locations: 🇺🇸
University of Michigan University Hospital, Ann Arbor, Michigan, United States

Tacrolimus/Methotrexate Versus Cyclosporine/Methotrexate for Prophylaxis of Graft Versus Host Disease

Phase 2

Completed

Conditions: Graft vs Host Disease

Interventions: Drug: Tacrolimus
Drug: Cyclosporine
Drug: Methotrexate

First Posted Date: 2013-02-11

Last Posted Date: 2017-03-22

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 50

Registration Number: NCT01788501

Locations: 🇰🇷
Asan Medical Center, Seoul, Korea, Republic of
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

Phase 2

Conditions: B-cell Lymphoma Refractory

Interventions: Drug: Thiotepa
Drug: Busulfan
Drug: Fludarabin
Procedure: transplant (HCT)
Radiation: Cytoreduction
Drug: Immunosuppression
Drug: Cyclosporine
Drug: Methotrexate
Drug: ATG
Procedure: Collection and infusions of Donor PBSC

First Posted Date: 2013-02-07

Last Posted Date: 2014-07-08

Lead Sponsor: Azienda Ospedaliera San Giovanni Battista

Target Recruit Count: 42

Registration Number: NCT01786018

Locations: 🇮🇹
Città della Salute e della Scienza di Torino, Torino, Italy

GVAX vs. Placebo for MDS/AML After Allo HSCT

Phase 2

Terminated

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia

Interventions: Biological: GVAX
Biological: Placebo Vaccine
Procedure: Allogeneic Hematopoietic Stem Cell Transplant
Drug: Busulfan
Drug: Fludarabine
Drug: Tacrolimus
Drug: Methotrexate

First Posted Date: 2013-01-23

Last Posted Date: 2022-07-18

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 123

Registration Number: NCT01773395

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Bortezomib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 2

Completed

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia (ALL)
Ph-positive Adult Acute Lymphoblastic Leukemia (ALL)
B-cell Adult Acute Lymphoblastic Leukemia (ALL)
T-cell Adult Acute Lymphoblastic Leukemia (ALL)

Interventions: Drug: Bortezomib
Drug: Doxorubicin hydrochloride (HCl)
Drug: PEG-Asparaginase
Drug: Vincristine sulfate
Drug: Dexamethasone
Drug: Cytarabine
Drug: Methotrexate

First Posted Date: 2013-01-16

Last Posted Date: 2018-11-14

Lead Sponsor: Stanford University

Target Recruit Count: 18

Registration Number: NCT01769209

Locations: 🇺🇸
Stanford University, School of Medicine, Stanford, California, United States

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: sarilumab SAR153191 (REGN88)
Drug: tocilizumab
Drug: hydroxychloroquine
Drug: methotrexate
Drug: sulfasalazine
Drug: leflunomide
Drug: intravenous placebo
Drug: subcutaneous placebo

First Posted Date: 2013-01-15

Last Posted Date: 2017-06-26

Lead Sponsor: Sanofi

Target Recruit Count: 202

Registration Number: NCT01768572

Locations: 🇺🇸
Investigational Site Number 840033, Fort Lauderdale, Florida, United States
🇺🇸
Investigational Site Number 840150, Lansing, Michigan, United States
🇺🇸
Investigational Site Number 840022, Dallas, Texas, United States

and more 75 locations

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Phase 3

Terminated

Conditions: Rheumatoid Arthritis

Interventions: Drug: Sarilumab
Drug: Etanercept
Drug: Adalimumab
Drug: Methotrexate
Drug: Placebo (for etanercept)
Drug: Placebo (for sarilumab)

First Posted Date: 2013-01-10

Last Posted Date: 2017-07-27

Lead Sponsor: Sanofi

Target Recruit Count: 776

Registration Number: NCT01764997

Locations: 🇺🇸
Investigational Site Number 840203, Washington, D.C., District of Columbia, United States
🇦🇷
Investigational Site Number 032009, Zarate, Argentina
🇨🇱
Investigational Site Number 152018, Santiago, Chile

and more 254 locations