CLINICAL TRIALS PROFILE FOR SIMPONI ARIA

All Clinical Trials for SIMPONI ARIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01212653 ↗	Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)	Completed	Chinese University of Hong Kong	Phase 4	2010-10-01	1. To determine the effect of Golimumab treatment on the number and function of Endothelial Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a possible mechanism for the effect of this treatment on endothelial function. 2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness, vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave velocity (PWV) and Augmentation index (AIx). 3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS) patients according to ASAS response criteria at month 3, 6 and 12. 4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing Spondylitis(AS) patients, using clinic-base data.
NCT01258777 ↗	A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects	Completed	Centocor, Inc.	Phase 1	2010-10-01	The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and Caucasian Males.
NCT01288157 ↗	A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects	Completed	Centocor, Inc.	Phase 1	2010-09-01	The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.
NCT01313858 ↗	A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)	Completed	Merck Sharp & Dohme Corp.		2010-04-01	This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.
NCT01526174 ↗	Intratympanic Injection for Autoimmune Inner Ear Disease	Terminated	Janssen Services, LLC	Phase 1/Phase 2	2012-03-01	The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.
NCT01526174 ↗	Intratympanic Injection for Autoimmune Inner Ear Disease	Terminated	House Research Institute	Phase 1/Phase 2	2012-03-01	The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.
NCT01548768 ↗	RHYTHM (Formerly Escape II Myocardium)	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 4	2011-10-10	For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls. For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care. The investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function).

Clinical Trial Conditions for SIMPONI ARIA

Condition Name

Condition Name for SIMPONI ARIA
Intervention	Trials
Psoriatic Arthritis	8
Rheumatoid Arthritis	6
Ulcerative Colitis	3
Arthritis, Psoriatic	3

Condition MeSH

Condition MeSH for SIMPONI ARIA
Intervention	Trials
Arthritis	14
Arthritis, Psoriatic	11
Arthritis, Rheumatoid	7
Colitis, Ulcerative	6

Clinical Trial Locations for SIMPONI ARIA

Trials by Country

Trials by Country for SIMPONI ARIA
Location	Trials
United States	24
China	4
Germany	4
Canada	4
Poland	2

Trials by US State

Trials by US State for SIMPONI ARIA
Location	Trials
Pennsylvania	3
Arizona	2
Virginia	2
New York	2
California	2

Clinical Trial Progress for SIMPONI ARIA

Clinical Trial Phase

Clinical Trial Phase for SIMPONI ARIA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2	2

Clinical Trial Status

Clinical Trial Status for SIMPONI ARIA
Clinical Trial Phase	Trials
Completed	13
Not yet recruiting	5
Recruiting	4

Clinical Trial Sponsors for SIMPONI ARIA

Sponsor Name

Sponsor Name for SIMPONI ARIA
Sponsor	Trials
Janssen Research & Development, LLC	3
Merck Sharp & Dohme Corp.	3
Bio-Thera Solutions	3

Sponsor Type

Sponsor Type for SIMPONI ARIA
Sponsor	Trials
Other	21
Industry	17
NIH	2

SIMPONI ARIA Market Analysis and Financial Projection

SIMPONI ARIA (Golimumab): Clinical Trials Update, Market Analysis, and Projections

Introduction to SIMPONI ARIA

SIMPONI ARIA (golimumab) is an intravenously administered, fully human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody. It is used to treat various chronic inflammatory diseases, including moderately to severely active rheumatoid arthritis (RA) and active ankylosing spondylitis (AS)[3][4].

Clinical Trials Update

Rheumatoid Arthritis Trials

In clinical trials for rheumatoid arthritis, SIMPONI ARIA has demonstrated significant efficacy. A Phase 3 study showed that nearly 70% of patients receiving SIMPONI ARIA achieved an ACR20 response at two years, indicating a 20% improvement in the American College of Rheumatology (ACR) criteria. This includes improvements in swollen joint count, tender joint count, and other clinical parameters[3].

• ACR20, ACR50, and ACR70 Responses: At Week 14, 30% of patients achieved an ACR50 response and 12% achieved an ACR70 response in the SIMPONI ARIA group, compared to 9% and 3%, respectively, in the placebo group. By Week 24, these numbers increased to 35% for ACR50 and 18% for ACR70 in the SIMPONI ARIA group, versus 13% and 4% in the placebo group[1].

Ankylosing Spondylitis Trials

The GO-ALIVE study, a pivotal Phase 3 trial, evaluated the efficacy and safety of SIMPONI ARIA in patients with active ankylosing spondylitis. The study found that 73.3% of patients receiving SIMPONI ARIA achieved the primary endpoint of at least a 20% improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at Week 16, compared to 26.2% in the placebo group[4].

Safety Profile

Adverse Events

Clinical trials have highlighted the safety profile of SIMPONI ARIA. Common adverse events include infections, with nasopharyngitis being the most common. Serious adverse events are rare, with low rates of infusion reactions and no opportunistic infections, malignancies, or deaths reported in the GO-ALIVE study through Week 28[4].

Serious Infections

Patients treated with SIMPONI ARIA are at an increased risk for developing serious infections that may lead to hospitalization or death. This risk is a significant consideration in the management of patients on this therapy[5].

Market Analysis

Current Market Position

SIMPONI ARIA is approved for use in several countries, including the United States, for the treatment of moderately to severely active rheumatoid arthritis in combination with methotrexate and for active ankylosing spondylitis. Its market position is strong due to its efficacy and the established need for anti-TNF therapies in these chronic inflammatory diseases[3][4].

Biosimilar Developments

The European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi (golimumab). This development is expected to impact the market dynamics, potentially increasing competition and reducing costs for patients. The approvals process is anticipated to be completed in the fourth quarter of 2025[2].

Market Projections

Growth Potential

The market for biologic therapies, including anti-TNF agents like SIMPONI ARIA, is expected to continue growing due to the increasing prevalence of chronic inflammatory diseases and the high demand for effective treatments. The introduction of biosimilars, however, may moderate this growth by providing more affordable alternatives.

Competitive Landscape

The competitive landscape for SIMPONI ARIA includes other anti-TNF therapies such as REMICADE (infliximab) and newer biologics targeting different pathways. The entry of biosimilars will further intensify competition, but SIMPONI ARIA’s established efficacy and safety profile are likely to maintain its market share.

Patient Access and Affordability

Impact of Biosimilars

The approval of biosimilars like AVT05 is expected to improve patient access to biologic therapies by reducing costs. This could lead to increased market penetration for SIMPONI ARIA and its biosimilars, especially in regions with stringent healthcare budgets.

Regulatory Environment

Approvals and Submissions

SIMPONI ARIA has received approvals from regulatory bodies such as the U.S. FDA for its use in rheumatoid arthritis and ankylosing spondylitis. Ongoing submissions, such as the one for AVT05, indicate a dynamic regulatory environment that continues to evolve with new data and biosimilar applications[2][4].

Conclusion

SIMPONI ARIA remains a significant player in the treatment of chronic inflammatory diseases, backed by robust clinical trial data and a well-established safety profile. The impending introduction of biosimilars and ongoing regulatory activities will shape its market position and patient access in the coming years.

Key Takeaways

• Efficacy: SIMPONI ARIA has shown significant efficacy in treating rheumatoid arthritis and ankylosing spondylitis.
• Safety: The drug has a manageable safety profile, though it carries risks of serious infections.
• Market Dynamics: The introduction of biosimilars is expected to impact market competition and patient access.
• Regulatory Environment: Ongoing regulatory activities, including biosimilar approvals, will continue to shape the market.
• Growth Potential: The market for biologic therapies is expected to grow, with SIMPONI ARIA maintaining a strong position.

FAQs

Q: What is SIMPONI ARIA used for?

A: SIMPONI ARIA is used to treat moderately to severely active rheumatoid arthritis in combination with methotrexate and active ankylosing spondylitis.

Q: How effective is SIMPONI ARIA in clinical trials?

A: In clinical trials, SIMPONI ARIA has shown significant efficacy, with nearly 70% of patients achieving an ACR20 response at two years in rheumatoid arthritis trials and 73.3% achieving ASAS20 in ankylosing spondylitis trials.

Q: What are the common adverse events associated with SIMPONI ARIA?

A: Common adverse events include infections, with nasopharyngitis being the most common. Serious adverse events are rare but can include serious infections.

Q: Are there any biosimilars to SIMPONI ARIA in development?

A: Yes, the EMA has accepted a Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi (golimumab).

Q: How will the introduction of biosimilars affect the market for SIMPONI ARIA?

A: The introduction of biosimilars is expected to increase competition and reduce costs, potentially improving patient access to biologic therapies.

Sources

1. SIMPONI ARIA® (golimumab) RA Clinical Trial: ACR Response | HCP. Retrieved from https://www.simponiariahcp.com/rheumatoid-arthritis/efficacy/acr-response/
2. EMA Confirms Acceptance of Marketing Authorization Application for AVT05, Alvotech's Proposed Biosimilar to Simponi. Retrieved from https://drug-dev.com/ema-confirms-acceptance-of-marketing-authorization-application-for-a-proposed-biosimilar-to-simponi/
3. New Two-Year Results Show SIMPONI® ARIA™ (GOLIMUMAB) For Infusion Inhibited Radiographic Progression In Patients With Active Rheumatoid Arthritis. Retrieved from https://www.jnj.com/media-center/press-releases/new-two-year-results-show-simponi-aria-golimumab-for-infusion-inhibited-radiographic-progression-in-patients-with-active-rheumatoid-arthritis
4. New Phase 3 Data Show Simponi Aria® (Golimumab) Significantly Improved Signs and Symptoms in Patients With Active Ankylosing Spondylitis. Retrieved from https://www.jnj.com/media-center/press-releases/new-phase-3-data-show-simponi-aria-golimumab-significantly-improved-signs-and-symptoms-in-patients-with-active-ankylosing-spondylitis
5. The AWARE Study (Interim Analysis). Retrieved from https://www.aware-study.com/aware-study/