CLINICAL TRIALS PROFILE FOR TREXALL

All Clinical Trials for Trexall

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00022516 ↗	Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer	Completed	International Breast Cancer Study Group	Phase 3	2000-11-01	This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00083031 ↗	Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer	Completed	Genentech, Inc.	Phase 2	2003-07-01	This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.

Clinical Trial Conditions for Trexall

Condition Name

Condition Name for Trexall
Intervention	Trials
Acute Lymphoblastic Leukemia	9
Leukemia	5
Acute Graft Versus Host Disease	3
Hematopoietic Stem Cell Transplantation	3

Condition MeSH

Condition MeSH for Trexall
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	21
Leukemia	20
Leukemia, Lymphoid	18
Graft vs Host Disease	7

Clinical Trial Locations for Trexall

Trials by Country

Trials by Country for Trexall
Location	Trials
United States	446
Canada	62
Australia	29
Switzerland	4
Brazil	4

Trials by US State

Trials by US State for Trexall
Location	Trials
California	19
Maryland	18
Illinois	18
Michigan	17
Ohio	17

Clinical Trial Progress for Trexall

Clinical Trial Phase

Clinical Trial Phase for Trexall
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Trexall
Clinical Trial Phase	Trials
Completed	21
Terminated	8
Active, not recruiting	7

Clinical Trial Sponsors for Trexall

Sponsor Name

Sponsor Name for Trexall
Sponsor	Trials
National Cancer Institute (NCI)	13
Therapeutic Advances in Childhood Leukemia Consortium	7
Children's Oncology Group	5

Sponsor Type

Sponsor Type for Trexall
Sponsor	Trials
Other	72
Industry	23
NIH	15

Trexall: Clinical Trials, Market Analysis, and Projections

Introduction to Trexall

Trexall, a brand name for methotrexate, is a widely used medication in the treatment of various conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and several types of cancer. Here, we will delve into the clinical trials, market analysis, and future projections for Trexall.

Clinical Trials and Efficacy

Long-Term Efficacy in Rheumatoid Arthritis

Clinical trials have demonstrated the long-term efficacy of methotrexate in treating rheumatoid arthritis. A prospective study involving 26 patients with severe rheumatoid arthritis showed significant improvements over 36 months. Patients experienced reductions in the number of painful and swollen joints, improved physician and patient global assessments, and decreased erythrocyte sedimentation rates. Additionally, the prednisone dose was reduced, indicating a positive impact on disease management[1].

Safety and Tolerability

The same study highlighted that while adverse reactions were common, they were generally manageable. Common side effects included nausea, alopecia, headache, stomatitis, herpes zoster, and diarrhea. More serious but rare side effects, such as mild leukopenia, thrombocytopenia, and elevated transaminase levels, resolved with temporary drug discontinuation. No patients withdrew from the study due to drug toxicity, and liver biopsies showed no evidence of fibrosis or cirrhosis after 24 months of treatment[1].

Market Analysis

Global Rheumatology Therapeutics Market

The global rheumatology therapeutics market, in which Trexall is a key player, is highly competitive and consolidated. As of 2016, the market was valued at $41.88 billion and is expected to grow at a CAGR of 2.7% from 2017 to 2025, reaching $52.96 billion by the end of 2025. The biologic DMARDs segment, which includes methotrexate, is a significant contributor to this growth, expected to rise from $35.83 billion in 2016 to $45.06 billion by 2025[2].

Regional Market Share

North America dominates the global rheumatology therapeutics market, largely due to the increasing elderly population and the higher prevalence of rheumatology diseases in this region. The rising demand for effective treatments like Trexall is a key driver of market growth[2].

Market Projections

Growing Demand for Rheumatology Therapeutics

The increasing prevalence of rheumatology diseases is a major factor driving the growth of the rheumatology therapeutics market. As the population ages and the incidence of conditions like rheumatoid arthritis and psoriasis rises, the demand for medications like Trexall is expected to increase. This trend is anticipated to continue, supporting the market's projected growth[2].

Competitive Landscape

The market for rheumatology therapeutics is highly competitive, with strong players dominating the landscape. However, the continued efficacy and safety profile of Trexall, along with its established presence, position it as a significant player in this market. The introduction of new biologic DMARDs and other therapeutic options may pose competition, but Trexall's long-standing reputation and clinical evidence support its continued market share[2].

Clinical Trials and Development Trends

Ongoing Clinical Trials

While specific ongoing clinical trials for Trexall itself may be limited due to its established status, the broader landscape of rheumatology and oncology clinical trials is vibrant. New therapies and combination regimens are being explored, which could impact the future use and positioning of Trexall. For instance, breakthrough designations and expedited review processes are being utilized to bring new treatments to market more quickly, potentially influencing the competitive landscape[4].

Novel Therapies and Combination Regimens

The development of novel drugs and therapies is a significant trend in the pharmaceutical industry. In 2020, approximately 550 new medicines were in development in the USA alone, many of which are targeted at conditions treated by Trexall. This innovation could lead to new combination regimens or alternative treatments, but it also underscores the ongoing need for established and effective medications like Trexall[3].

Key Takeaways

• Long-term Efficacy: Trexall has demonstrated long-term efficacy in treating rheumatoid arthritis with acceptable toxicity levels.
• Market Growth: The global rheumatology therapeutics market is expected to grow to $52.96 billion by 2025, driven by the increasing prevalence of rheumatology diseases.
• Competitive Landscape: Trexall remains a significant player in a highly competitive market, supported by its established safety and efficacy profile.
• Clinical Trials: Ongoing clinical trials in rheumatology and oncology may introduce new therapies and combination regimens, but Trexall's position is solidified by its long history of use.

FAQs

What are the primary indications for Trexall?

Trexall is indicated for the treatment of adults and pediatric patients with acute lymphoblastic leukemia, adults with mycosis fungoides, relapsed or refractory non-Hodgkin lymphomas, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis[5].

What are the common side effects of Trexall?

Common side effects include nausea, alopecia, headache, stomatitis, herpes zoster, and diarrhea. More serious but rare side effects can include mild leukopenia, thrombocytopenia, and elevated transaminase levels[1][5].

How is the global rheumatology therapeutics market expected to grow?

The market is expected to grow from $41.88 billion in 2016 to $52.96 billion by 2025, with a CAGR of 2.7% from 2017 to 2025[2].

What drives the demand for Trexall and other rheumatology therapeutics?

The increasing prevalence of rheumatology diseases, particularly among the elderly population, drives the demand for these medications[2].

Are there ongoing clinical trials that could impact Trexall's market position?

Yes, ongoing clinical trials in rheumatology and oncology are exploring new therapies and combination regimens, which could influence the future use and positioning of Trexall[3][4].

Sources

1. Long-term Prospective Trial of Low-Dose Methotrexate in ... - PubMed
2. Rheumatology Therapeutics Market is Likely to Grow Around Worth ... - Biospace
3. Clinical Trials Market Size & Share, Growth Trends 2037 - Research Nester
4. Clinical trials appendix H1 2022 results update - AstraZeneca
5. Trexall: Package Insert / Prescribing Information - Drugs.com