CLINICAL TRIALS PROFILE FOR OTREXUP

All Clinical Trials for OTREXUP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	National Cancer Institute (NCI)	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00335140 ↗	Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma	Terminated	Eastern Cooperative Oncology Group	Phase 2	2006-12-01	RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Abbott	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
NCT00439296 ↗	ABT-751 With Chemotherapy for Relapsed Pediatric ALL	Terminated	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2	2006-05-22	This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.
NCT00440726 ↗	Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)	Completed	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1/Phase 2	2006-08-04	This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.
NCT00928200 ↗	Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)	Terminated	Therapeutic Advances in Childhood Leukemia Consortium	Phase 1	2009-04-13	This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.
NCT01371630 ↗	Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2011-08-26	This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating older patients with previously untreated acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.

Clinical Trial Conditions for OTREXUP

Condition Name

Condition Name for OTREXUP
Intervention	Trials
Acute Lymphoblastic Leukemia	3
Lymphoblastic Leukemia, Acute, Childhood	1
Lymphoma	1
Myelogenous Leukemia, Acute, Childhood	1

Condition MeSH

Condition MeSH for OTREXUP
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	6
Leukemia, Lymphoid	6
Leukemia	6
Leukemia, Myeloid, Acute	1

Clinical Trial Locations for OTREXUP

Trials by Country

Trials by Country for OTREXUP
Location	Trials
United States	68
Canada	6
Australia	5
Brazil	1

Trials by US State

Trials by US State for OTREXUP
Location	Trials
Minnesota	5
Michigan	5
Florida	5
California	5
Ohio	4

Clinical Trial Progress for OTREXUP

Clinical Trial Phase

Clinical Trial Phase for OTREXUP
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	3
Phase 1	3

Clinical Trial Status

Clinical Trial Status for OTREXUP
Clinical Trial Phase	Trials
Terminated	3
Recruiting	2
Completed	2

Clinical Trial Sponsors for OTREXUP

Sponsor Name

Sponsor Name for OTREXUP
Sponsor	Trials
Therapeutic Advances in Childhood Leukemia Consortium	4
National Cancer Institute (NCI)	2
Pfizer	2

Sponsor Type

Sponsor Type for OTREXUP
Sponsor	Trials
Other	12
Industry	3
NIH	2

OTREXUP Market Analysis and Financial Projection

Otrexup: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Otrexup, a subcutaneous injection of methotrexate, has been a significant development in the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (p-JRA), and severe psoriasis. Here, we delve into the clinical trials, market analysis, and projections for this innovative drug.

Clinical Trials and Efficacy

Bioavailability and Pharmacokinetics

Clinical trials have demonstrated that Otrexup offers superior bioavailability compared to oral methotrexate. A randomized, multicenter, open-label, crossover study showed that Otrexup delivered higher systemic exposure of methotrexate than oral administration at doses of 10, 15, 20, and 25 mg, with increases of 17%, 13%, 31%, and 36%, respectively[1][4].

Comparative Studies

The relative bioavailability of Otrexup was found to be similar to intramuscular or subcutaneous methotrexate injections but significantly higher than oral methotrexate. This is crucial because oral methotrexate bioavailability plateaus at doses of 15 mg or greater, whereas Otrexup does not exhibit this plateau effect[1][4].

Patient Preference and Ease of Use

A phase 2 clinical trial involving 101 adults with RA evaluated the ease of use of Otrexup using an auto-injector device. The results indicated that patients found the auto-injector nearly pain-free and easy to use, addressing concerns about self-administration of methotrexate using conventional vials and syringes[4].

Safety and Monitoring

Important Safety Information

Otrexup carries significant safety warnings, including severe toxic reactions, embryo-fetal toxicity, and death. Patients must be closely monitored for toxic effects, with regular assessments of blood counts, hepatic enzymes, renal function, and chest X-rays. Special caution is advised for patients with impaired renal function, ascites, or pleural effusions, as methotrexate elimination is reduced in these conditions[1].

Risks from Improper Dosing

Both physicians and pharmacists must emphasize to patients that Otrexup is administered weekly, as mistaken daily use has led to fatal toxicity. This highlights the importance of strict adherence to the prescribed dosing schedule[1].

Market Analysis

Market Size and Growth

The global methotrexate market, which includes Otrexup, is expected to grow driven by increasing prevalence of cancers and arthritis. The injectable formulation of methotrexate, such as Otrexup, is anticipated to dominate the market due to its higher efficacy compared to oral formulations[5].

Segment Analysis

By formulation, injectable methotrexate is expected to lead the segment. Cancer treatment is projected to be the primary indication, followed by arthritis and psoriasis. Hospitals are likely to be the major end-users due to their advanced facilities and high treatment expenses[5].

Regional Outlook

North America currently dominates the global methotrexate market due to high prevalence rates of cancer, psoriasis, and arthritis, along with the presence of key players. Europe is the second largest market, while the Asia Pacific region is expected to grow at the fastest pace due to a large patient pool and advancing healthcare infrastructure[5].

Market Projections

Global Axial Spondyloarthritis Market

Although Otrexup is not specifically indicated for axial spondyloarthritis, the broader market for treatments of related conditions is significant. The global axial spondyloarthritis treatment market is estimated to reach $7.6 billion by 2031, growing at a CAGR of 5.1%. This growth is driven by increasing prevalence and the rapid uptake of premium-priced biologic therapies, which could indirectly influence the demand for methotrexate-based treatments[3].

Methotrexate Market Growth

The global methotrexate market is expected to leverage further with the increasing prevalence of cancer and arthritis. The Asia Pacific region is anticipated to grow at the fastest pace, while North America and Europe will continue to be significant markets due to their established healthcare infrastructures and high patient bases[5].

Key Takeaways

• Superior Bioavailability: Otrexup offers higher bioavailability compared to oral methotrexate, making it a preferred option for patients.
• Ease of Use: The auto-injector device of Otrexup is nearly pain-free and easy to use, addressing patient concerns about self-administration.
• Safety Monitoring: Close monitoring is required to detect toxic effects promptly, especially in patients with impaired renal function or other specific conditions.
• Market Growth: The global methotrexate market, driven by injectable formulations like Otrexup, is expected to grow significantly due to increasing prevalence of cancer and arthritis.
• Regional Dominance: North America and Europe are current leaders, while the Asia Pacific region is expected to show rapid growth.

FAQs

What is Otrexup used for?

Otrexup is used for the treatment of adults with severe active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of first-line therapy, as well as for children with active polyarticular juvenile idiopathic arthritis (p-JRA) and adults with severe psoriasis[2][4].

How does Otrexup compare to oral methotrexate in terms of bioavailability?

Otrexup has higher systemic exposure and bioavailability compared to oral methotrexate, especially at doses above 15 mg, where oral methotrexate bioavailability plateaus[1][4].

What are the safety concerns associated with Otrexup?

Otrexup carries risks of severe toxic reactions, embryo-fetal toxicity, and death. Patients must be closely monitored for toxic effects, and special caution is advised for those with impaired renal function, ascites, or pleural effusions[1].

Why is the auto-injector device of Otrexup significant?

The auto-injector device of Otrexup is nearly pain-free and easy to use, addressing patient concerns about self-administration of methotrexate using conventional vials and syringes[4].

What is the projected market growth for methotrexate-based treatments?

The global methotrexate market, including injectable formulations like Otrexup, is expected to grow driven by increasing prevalence of cancer and arthritis, with the Asia Pacific region showing the fastest growth rate[5].

Which regions dominate the methotrexate market?

North America and Europe currently dominate the global methotrexate market, while the Asia Pacific region is expected to grow rapidly due to a large patient pool and advancing healthcare infrastructure[5].

Sources

1. Otrexup - Hear from the Experts | Otrexup® (Methotrexate) subcutaneous injection.
2. FDA - 204824Orig2s000 - accessdata.fda.gov.
3. iHealthcareAnalyst - Global Axial Spondyloarthritis Market $7.6 Billion by 2031.
4. American Health & Drug Benefits - Otrexup (Methotrexate) Injection.
5. BioSpace - Methotrexate Market is expected to grow further with its Increasing Application in the Treatment of Cancer and Arthritis.