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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR OTREXUP PFS


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All Clinical Trials for Otrexup Pfs

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Otrexup Pfs

Condition Name

Condition Name for Otrexup Pfs
Intervention Trials
Acute Lymphoblastic Leukemia 3
Recurrent Pediatric ALL 1
Allergy to Native e.Coli Asparaginase 1
Refractory Pediatric ALL 1
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Condition MeSH

Condition MeSH for Otrexup Pfs
Intervention Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma 6
Leukemia, Lymphoid 6
Leukemia 6
Leukemia, Myeloid, Acute 1
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Clinical Trial Locations for Otrexup Pfs

Trials by Country

Trials by Country for Otrexup Pfs
Location Trials
United States 68
Canada 6
Australia 5
Brazil 1
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Trials by US State

Trials by US State for Otrexup Pfs
Location Trials
Minnesota 5
Michigan 5
Florida 5
California 5
Washington 4
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Clinical Trial Progress for Otrexup Pfs

Clinical Trial Phase

Clinical Trial Phase for Otrexup Pfs
Clinical Trial Phase Trials
Phase 2 1
Phase 1/Phase 2 3
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Otrexup Pfs
Clinical Trial Phase Trials
Terminated 3
Completed 2
Recruiting 2
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Clinical Trial Sponsors for Otrexup Pfs

Sponsor Name

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

Sponsor Type for Otrexup Pfs
Sponsor Trials
Other 12
Industry 3
NIH 2
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Otrexup PFS: Clinical Trials, Market Analysis, and Projections

Introduction to Otrexup PFS

Otrexup PFS is a subcutaneous injection of methotrexate, a folate analog metabolic inhibitor, indicated for the management of severe, active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Bioavailability and GI Adverse Events

Otrexup PFS was approved through the 505(b)(2) pathway, which means it demonstrated bioequivalence to previously approved subcutaneous methotrexate formulations. No clinical trials were specifically conducted for Otrexup PFS, but studies on subcutaneous methotrexate have shown significant benefits. Subcutaneous methotrexate delivers higher bioavailability compared to oral methotrexate, particularly at doses above 15 mg, where oral absorption plateaus[1][3].

A survey of 70 adult RA patients with GI side effects from oral methotrexate found a reduction in the intensity of most measured GI adverse events after switching to subcutaneous methotrexate[1].

Patient Experience and Ease of Use

In a study involving 101 adult RA patients, 98% agreed that Otrexup PFS was easy to use. The auto-injector design, which hides the needle from the patient, contributed to minimal administration-site pain, with mean pain scores of 3.6 mm and 1.4 mm on Day 1 and Day 2, respectively[1].

Safety and Monitoring

While Otrexup PFS did not undergo specific clinical trials, the safety profile is based on extensive data from other methotrexate formulations. Patients must be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. The drug is contraindicated in patients with certain conditions, and females of childbearing potential must have pregnancy excluded before starting therapy[2].

Market Analysis

Indications and Target Population

Otrexup PFS is indicated for adults with severe, active RA and children with active pJIA who have not responded adequately to first-line therapies. It is also used for adults with severe, recalcitrant, disabling psoriasis. The target population includes patients who have experienced GI toxicity or poor bioavailability with oral methotrexate[2][3].

Market Need and Unmet Needs

There remains an unmet medical need for effective and tolerable treatments for RA and pJIA. Otrexup PFS addresses this need by offering a convenient, subcutaneous option with higher bioavailability and reduced GI adverse events compared to oral methotrexate. This makes it an attractive option for patients and physicians seeking to improve disease management[3][4].

Competitive Landscape

The market for methotrexate includes various formulations, such as oral preparations and other injectable forms. Otrexup PFS competes with products like Rasuvo, another subcutaneous methotrexate injection. However, Otrexup's ease of use, particularly its auto-injector design, sets it apart in terms of patient convenience and compliance[4].

Market Projections

Adoption and Uptake

The adoption of Otrexup PFS is expected to be driven by its practical benefits, including higher bioavailability and reduced GI side effects. Physicians who have been hesitant to prescribe injectable methotrexate due to concerns about patient compliance and administration accuracy are likely to find Otrexup PFS a more viable option. This could lead to increased market share in the rheumatology and dermatology sectors[3].

Revenue Projections

Given the established efficacy and safety of methotrexate and the specific advantages of Otrexup PFS, revenue projections are positive. The drug is likely to capture a significant portion of the market for patients transitioning from oral to subcutaneous methotrexate. As more patients and physicians become aware of the benefits of Otrexup PFS, sales are expected to grow steadily over the next few years.

Long-Term Outlook

The long-term outlook for Otrexup PFS is favorable, given the chronic nature of the conditions it treats. Patients with RA and pJIA often require long-term therapy, and the convenience and efficacy of Otrexup PFS make it a sustainable treatment option. As the patient population continues to grow, so will the demand for effective and easy-to-use treatments like Otrexup PFS[2][3].

Key Takeaways

  • Higher Bioavailability: Otrexup PFS offers higher bioavailability compared to oral methotrexate, particularly at doses above 15 mg.
  • Reduced GI Adverse Events: Switching to subcutaneous methotrexate can reduce the intensity of GI adverse events associated with oral methotrexate.
  • Ease of Use: The auto-injector design of Otrexup PFS makes it easy to use, with minimal administration-site pain.
  • Market Need: Otrexup PFS addresses an unmet medical need for effective and tolerable treatments for RA and pJIA.
  • Competitive Advantage: The convenience and patient compliance benefits of Otrexup PFS set it apart in the market.

FAQs

What is Otrexup PFS used for?

Otrexup PFS is used for the management of severe, active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

How does Otrexup PFS compare to oral methotrexate?

Otrexup PFS offers higher bioavailability and reduced gastrointestinal adverse events compared to oral methotrexate.

Is Otrexup PFS easy to use?

Yes, Otrexup PFS is designed with an auto-injector that hides the needle from the patient, making it easy to use with minimal administration-site pain.

What are the potential side effects of Otrexup PFS?

Patients should be monitored for bone marrow, liver, lung, skin, and kidney toxicities. Other potential side effects include those associated with methotrexate, such as GI adverse events, although these are reduced with subcutaneous administration.

Can Otrexup PFS be used in pregnant women?

No, females of childbearing potential should not be started on Otrexup PFS until pregnancy is excluded.

How long can Otrexup PFS be used?

The optimal duration of therapy is unknown, but clinical improvement is typically maintained for at least two years with continued therapy.

Sources

  1. Otrexup® (methotrexate) injection for subcutaneous use: Safety and efficacy clinical trials were not conducted with Otrexup. Subcutaneous methotrexate delivered higher bioavailability than oral methotrexate[1].
  2. Otrexup PFS (Methotrexate Injection): Uses, side effects, and dosage information for Otrexup PFS[2].
  3. Clinical Safety on the proposed Otrexup (MTX) Injectable, PFS Auto-Injector: FDA review of the new drug application for Otrexup, including its benefits and risks[3].
  4. Methotrexate Injection: Multi-disciplinary review and evaluation of methotrexate injection, including Otrexup PFS[4].

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