CLINICAL TRIALS PROFILE FOR INTERFERON BETA-1A

All Clinical Trials for interferon beta-1a

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1999-07-01	Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
NCT00000401 ↗	Oral Collagen for Rheumatoid Arthritis	Completed	University of Tennessee	Phase 2	1999-07-01	Rheumatoid arthritis (RA) is an autoimmune disease characterized by swelling and inflammation of the joints. In RA, the immune system attacks a person's own cells inside joints, eventually leading to joint damage and disability. This study will determine if oral bovine type II collagen (bovine CII) will lead to decreased joint inflammation in RA patients.
NCT00000647 ↗	An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To restore immunologic function and virus-free state in HIV-infected patients. Based on previous studies showing temporary improvement in immune function in HIV-infected patients using peripheral lymphocyte transfers and bone marrow transplantation, and based on studies documenting the antiretroviral effects of zidovudine (AZT) and interferon-alfa (IFN-A) as well as the preliminary test tube and patient studies suggesting anti-HIV effects of recombinant CD4-IgG, we propose to treat HIV-infected patients using combination antiretroviral therapy with transplantation of bone marrow and peripheral lymphocytes from previously immunized donors in an attempt to restore immunologic function and a virus-free state.
NCT00000687 ↗	Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens.
NCT00000694 ↗	A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To define the best doses of sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ), interferon alfa-2b ( IFN-A2b ), and zidovudine ( AZT ) to give together in patients with AIDS-associated Kaposi's sarcoma ( KS ), to learn about the side effects of these drugs when they are given together for 8 weeks, and to find out whether the combination of GM-CSF, IFN-A2b, and AZT has any effect on KS, HIV, or the immune system. Studies show that IFN-A2b can cause KS tumors to shrink or disappear in about 30 percent of patients. IFN-A2b can greatly reduce the growth of the HIV virus in test tube experiments and perhaps in patients. AZT has also been shown to reduce the growth of HIV and show improvements in the immune system with fewer infections. Test tube experiments show that when IFN-A2b and AZT are used together, they reduce the growth of the HIV virus much more effectively than when either drug is used alone. In recent studies of the combination of interferon alpha and AZT in patients with KS, more than 40 percent of the patients showed shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil) which is important in the body's defense against infection. Recombinant human GM-CSF is a human protein which is produced in bacteria. It has been shown to cause an increase in the WBC count.
NCT00000695 ↗	Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.
NCT00000696 ↗	A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone.

Clinical Trial Conditions for interferon beta-1a

Condition Name

Condition Name for interferon beta-1a
Intervention	Trials
Hepatitis C	224
Hepatitis C, Chronic	140
Chronic Hepatitis C	124
Multiple Sclerosis	82

Condition MeSH

Condition MeSH for interferon beta-1a
Intervention	Trials
Hepatitis	687
Hepatitis C	608
Hepatitis A	592
Hepatitis, Chronic	373

Clinical Trial Locations for interferon beta-1a

Trials by Country

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Trials by Country for interferon beta-1a
Location	Trials
Canada	422
Korea, Republic of	91
Taiwan	88
Netherlands	85
Puerto Rico	82

Trials by US State

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Trials by US State for interferon beta-1a
Location	Trials
Texas	275
California	267
New York	254
Maryland	220
Florida	195

Clinical Trial Progress for interferon beta-1a

Clinical Trial Phase

Clinical Trial Phase for interferon beta-1a
Clinical Trial Phase	Trials
Phase 4	278
Phase 3	395
Phase 2/Phase 3	63

Clinical Trial Status

Clinical Trial Status for interferon beta-1a
Clinical Trial Phase	Trials
Completed	1119
Unknown status	202
Terminated	188

Clinical Trial Sponsors for interferon beta-1a

Sponsor Name

Sponsor Name for interferon beta-1a
Sponsor	Trials
National Cancer Institute (NCI)	154
Hoffmann-La Roche	99
Merck Sharp & Dohme Corp.	87

Sponsor Type

Sponsor Type for interferon beta-1a
Sponsor	Trials
Other	1858
Industry	1069
NIH	316

Interferon Beta-1a: Clinical Trials, Market Analysis, and Projections

Introduction

Interferon beta-1a (IFN beta-1a) has been a cornerstone in the treatment of multiple sclerosis (MS) for over 25 years. This article provides an update on recent clinical trials, market analysis, and projections for this crucial drug.

Clinical Trials and Efficacy

Long-Term Use and Efficacy

IFN beta-1a has been continuously used since its regulatory approval in Europe in 1998 and in the U.S.A. in 2002. The pivotal trial PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) and its long-term extension have provided significant insights into its efficacy. The trial showed that IFN beta-1a significantly reduces the risk of relapses and disability progression. For instance, the proportion of patients with no evidence of disease activity (NEDA-3) in the first year was 30.1% in the high-dose group compared to 10.9% in the placebo group[1].

Recent Clinical Studies

Recent clinical studies have reinforced the efficacy of IFN beta-1a. A Bayesian network meta-analysis revealed that IFN beta-1a (44 μg) had a rate ratio of annualized relapse rate and hazard ratios of time to 3-month and 6-month confirmed disability progression of 0.64, 0.66, and 0.78, respectively, compared to placebo[1].

Use Across Patient Life Span

IFN beta-1a is used across a wide spectrum of patient ages, including children, adolescents, and adults. The safety profile is similar across these age groups, and the drug has been shown to be effective in reducing disease progression over prolonged periods[1].

Bridging Therapy and Adherence

IFN beta-1a is also used as a bridging therapy, helping patients transition between different treatments. Support for adherence to the prescribed regimen is crucial, as continuous treatment has been associated with lower risks of relapse and disability progression[1].

Market Analysis

Current Market Size and Growth

The global interferon beta drugs market, which includes IFN beta-1a, was valued at USD 3.22 billion in 2023 and is projected to reach USD 4.66 billion by 2031, growing at a CAGR of 4.9% during the forecast period[2].

Regional Dominance

Europe currently dominates the market, driven by government initiatives, increasing healthcare expenditure, and the presence of major players such as Bayer, Novartis, and Merck KGaA. North America is also expected to be a significant market due to high healthcare spending and a large patient base[2][5].

Product Types and Administration Routes

The market is segmented by product type, with IFN beta-1a being a major segment. The drug can be administered subcutaneously, intravenously, or intramuscularly. Recent developments include the FDA approval of an intramuscular injection route for IFN beta-1a, which reduces injection site reactions[2][5].

Market Projections

Growth Drivers

The growth of the interferon beta drugs market is driven by several factors, including the increasing prevalence of multiple sclerosis, rising R&D activities, and surging demand for combination therapies. Government initiatives to improve healthcare infrastructure and financial assistance for chronic disease treatments also contribute to market growth[2][5].

Challenges

Despite the growth, the high cost of treatment remains a significant barrier to access, limiting market expansion. However, the presence of major players and the development of novel interferon beta drugs are expected to mitigate these challenges[2][5].

Recent Developments

New Administration Routes

In February 2021, Biogen Inc. received FDA approval for an intramuscular (IM) injection route of administration for IFN beta-1a, providing an alternative with reduced injection site reactions[2].

COVID-19 Studies

IFN beta-1a has been studied in the context of COVID-19, although it did not show significant benefits in reducing mortality, hospitalization duration, or ventilation initiation in a large international trial. However, inhaled IFN beta-1a is being investigated in clinical trials for its potential in treating COVID-19 patients not requiring hospitalization[3].

Key Takeaways

• Long-Term Efficacy: IFN beta-1a has been shown to reduce relapses and disability progression over 25 years of continuous use.
• Market Growth: The global interferon beta drugs market is projected to grow from USD 3.22 billion in 2023 to USD 4.66 billion by 2031.
• Regional Dominance: Europe and North America are expected to dominate the market due to high healthcare spending and government initiatives.
• New Administration Routes: Recent FDA approvals include intramuscular injection routes, offering patients alternative treatment options.
• Challenges: High treatment costs remain a barrier, but ongoing R&D and government support are expected to drive market growth.

FAQs

What is the primary use of interferon beta-1a?

Interferon beta-1a is primarily used as a disease-modifying treatment for multiple sclerosis (MS), reducing relapses and disability progression.

How long has interferon beta-1a been in clinical use?

IFN beta-1a has been in continuous clinical use for over 25 years since its regulatory approval in Europe in 1998 and in the U.S.A. in 2002.

What are the different administration routes for interferon beta-1a?

IFN beta-1a can be administered subcutaneously, intravenously, or intramuscularly, with recent approvals for intramuscular routes.

What are the key drivers of the interferon beta drugs market?

The market is driven by the increasing prevalence of MS, rising R&D activities, and surging demand for combination therapies, along with government initiatives and increasing healthcare expenditure.

What challenges does the interferon beta drugs market face?

The high cost of treatment is a significant barrier to access, limiting market growth, although ongoing R&D and government support are expected to mitigate these challenges.

Sources

1. Tandfonline: Interferon beta-1a sc at 25 years: a mainstay in the treatment of multiple sclerosis.
2. Insightaceanalytic: Interferon Beta Drugs Market Analysis and Forecast 2024-2031.
3. Globenewswire: Interferon Beta Drugs Market Value Anticipated To Reach US$ 4.827.6 Million By 2027.
4. Neurology.org: Alemtuzumab more effective than interferon β-1a at 5-year follow-up.
5. Acumen Research and Consulting: Interferon Beta Drugs Market Size, Share and Analysis | Forecast.