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Generated: January 19, 2019

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CLINICAL TRIALS PROFILE FOR METHOTREXATE

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Clinical Trials for methotrexate

Trial ID Title Status Sponsor Phase Summary
NCT00000361 Autoimmunity in Inner Ear Disease Terminated National Institute on Deafness and Other Communication Disorders (NIDCD) Phase 3 The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant.
NCT00000395 Antifolate Effectiveness in Arthritis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 This study looks at how the arthritis drug methotrexate works in low doses to treat rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.) Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the biochemical reactions affected by this vitamin because we think that blocking many of these reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through these studies, we hope to gain a better understanding of how this drug and related drugs work as treatments for arthritis.
NCT00000395 Antifolate Effectiveness in Arthritis Completed Office of Dietary Supplements (ODS) Phase 2 This study looks at how the arthritis drug methotrexate works in low doses to treat rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.) Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the biochemical reactions affected by this vitamin because we think that blocking many of these reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through these studies, we hope to gain a better understanding of how this drug and related drugs work as treatments for arthritis.
NCT00000395 Antifolate Effectiveness in Arthritis Completed University of Alabama at Birmingham Phase 2 This study looks at how the arthritis drug methotrexate works in low doses to treat rheumatoid arthritis. (High doses of methotrexate are used to treat some types of cancer.) Methotrexate blocks the action of the B-vitamin known as folic acid. We are studying the biochemical reactions affected by this vitamin because we think that blocking many of these reactions may be necessary for methotrexate to work in treating rheumatoid arthritis. Through these studies, we hope to gain a better understanding of how this drug and related drugs work as treatments for arthritis.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed Schering-Plough Phase 3 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000689 Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV. Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but the toxicity is very high. Patients treated with mBACOD have very low white blood cell counts. GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies. It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for methotrexate

Condition Name

Condition Name for methotrexate
Intervention Trials
Rheumatoid Arthritis 411
Leukemia 197
Lymphoma 132
Arthritis, Rheumatoid 71
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Condition MeSH

Condition MeSH for methotrexate
Intervention Trials
Arthritis 553
Arthritis, Rheumatoid 518
Leukemia 377
Lymphoma 258
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Clinical Trial Locations for methotrexate

Trials by Country

Trials by Country for methotrexate
Location Trials
Canada 702
Hungary 96
Netherlands 89
South Africa 81
India 81
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Trials by US State

Trials by US State for methotrexate
Location Trials
Texas 378
California 345
Pennsylvania 295
Florida 281
New York 279
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Clinical Trial Progress for methotrexate

Clinical Trial Phase

Clinical Trial Phase for methotrexate
Clinical Trial Phase Trials
Phase 4 190
Phase 3 443
Phase 2/Phase 3 46
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Clinical Trial Status

Clinical Trial Status for methotrexate
Clinical Trial Phase Trials
Completed 819
Recruiting 328
Terminated 152
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Clinical Trial Sponsors for methotrexate

Sponsor Name

Sponsor Name for methotrexate
Sponsor Trials
National Cancer Institute (NCI) 284
M.D. Anderson Cancer Center 84
Hoffmann-La Roche 70
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Sponsor Type

Sponsor Type for methotrexate
Sponsor Trials
Other 1595
Industry 831
NIH 366
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Teva
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Boehringer Ingelheim
Medtronic
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US Army
US Department of Justice
Cantor Fitzgerald
Fuji

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