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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 Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 2
Terminated
Conditions
Rheumatoid Arthritis
Interventions
Drug: JNJ-38518168
Drug: Placebo
Drug: Methotrexate
First Posted Date
2013-05-24
Last Posted Date
2015-07-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
21
Registration Number
NCT01862224

BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success

Phase 4
Conditions
Ectopic Pregnancy
Interventions
First Posted Date
2013-05-23
Last Posted Date
2013-05-23
Lead Sponsor
Meir Medical Center
Target Recruit Count
100
Registration Number
NCT01860690
Locations
🇮🇱

Dr. Zvi Klein, Kefar-saba, Israel

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children

Phase 2
Completed
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Biphenotypic Leukemia
Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Adult Acute Lymphoblastic Leukemia
Refractory Childhood Acute Lymphoblastic Leukemia
Acute Leukemia of Ambiguous Lineage
Adult Acute Myeloid Leukemia in Remission
Childhood Acute Lymphoblastic Leukemia in Remission
Interventions
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Drug: Tacrolimus
Drug: Thiotepa
Radiation: Total-Body Irradiation
First Posted Date
2013-05-21
Last Posted Date
2024-03-12
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
20
Registration Number
NCT01858740
Locations
🇺🇸

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

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Phase 3
Active, not recruiting
Conditions
Head and Neck Neoplasms
Interventions
First Posted Date
2013-05-17
Last Posted Date
2024-10-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
340
Registration Number
NCT01856478
Locations
🇨🇳

Harbin Medical University Cancer Hospital, Harbin, China

🇨🇳

Beijing Chao-Yang Hospital, Beijing, China

🇨🇳

Cancer Hospital of Chinese Academy of Medical Science, Beijing, China

and more 49 locations

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
First Posted Date
2013-05-09
Last Posted Date
2014-01-28
Lead Sponsor
Sanofi
Target Recruit Count
61
Registration Number
NCT01850680
Locations
🇯🇵

Investigational Site Number 392002, Sendai-Shi, Japan

🇯🇵

Investigational Site Number 392001, Sendai-Shi, Japan

Methotrexate and Mycophenolate Mofetil for UVEITIS

Phase 3
Completed
Conditions
Uveitis
Interventions
First Posted Date
2013-04-11
Last Posted Date
2024-04-02
Lead Sponsor
University of California, San Francisco
Target Recruit Count
216
Registration Number
NCT01829295
Locations
🇮🇳

Aravind Eye Hospital, Pondicherry, Tamil Nadu, India

🇸🇦

King Khaled Eye Specialist Hospital, Riyadh, Saudi Arabia

🇦🇺

Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia

and more 4 locations

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

Completed
Conditions
Psoriasis
First Posted Date
2013-03-18
Last Posted Date
2017-08-11
Lead Sponsor
Jochen Schmitt.
Target Recruit Count
1
Registration Number
NCT01812954

T&B Depletion Non Malignant

Phase 2
Conditions
Graft Versus Host Disease
Interventions
First Posted Date
2013-03-14
Last Posted Date
2013-03-14
Lead Sponsor
Franco Locatelli
Target Recruit Count
130
Registration Number
NCT01810926
Locations
🇮🇹

San Raffaele Scientific Institute, Milano, Italy

🇮🇹

University of Cagliari, Cagliari, Italy

🇮🇹

University of Milano-Bicocca San Gerardo Hospital, Monza, Italy

and more 1 locations

RCT for Women With a Persisting Pregnancy of Unknown Location

Phase 1
Terminated
Conditions
Persistent Pregnancy of Unknown Location
Ectopic Pregnancy
Interventions
Other: Expectant Management
Drug: Methotrexate
Procedure: Uterine Evacuation
First Posted Date
2013-02-27
Last Posted Date
2017-12-29
Lead Sponsor
University of Pennsylvania
Target Recruit Count
2
Registration Number
NCT01800162
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Greenville Hospital System University Medical Center, Greenville, South Carolina, United States

An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

Phase 3
Completed
Conditions
Giant Cell Arteritis
Interventions
First Posted Date
2013-02-13
Last Posted Date
2020-02-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
251
Registration Number
NCT01791153
Locations
🇺🇸

Univ of Calif., Los Angeles; Rheumatology, Los Angeles, California, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Rheumatology Assoc. of S. Florida - Clinical Research Center, Boca Raton, Florida, United States

and more 75 locations
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