What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs (e.g., naproxen, ibuprofen) and COX-2 inhibitors (e.g., celecoxib), are associated with gastrointestinal issues like ulcers and bleeding, cardiovascular risks including myocardial infarction, and renal side effects. Intra-articular injections, such as corticosteroids, can lead to joint infection, post-injection flare, and potential cartilage damage with repeated use. Investigational agents like anti-NGF antibodies (e.g., tanezumab, fasinumab) have shown efficacy in pain reduction but are linked to risks of rapidly progressive osteoarthritis, osteonecrosis, and peripheral nervous system effects.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis pain relief, including nonsteroidal anti-inflammatory drugs (NSAIDs) like celecoxib, naproxen, and ibuprofen, which are commonly used for their efficacy in reducing pain and inflammation. Additionally, anti-nerve growth factor (anti-NGF) agents such as tanezumab have been investigated for their potential to reduce pain, although safety concerns have limited their use. Intra-articular injections, such as corticosteroids, are also used but are generally recommended for short-term relief in patients who do not respond to other treatments. While RTX-GRT7039 is still under investigation, it represents a similar approach to these existing therapies by targeting pain relief through intra-articular administration.

What other types of research exist?

Promising novel alternatives to RTX-GRT7039 for osteoarthritis pain relief include: 1) Tanezumab, a nerve growth factor inhibitor, which has shown efficacy in multiple studies for knee and hip osteoarthritis. 2) Duloxetine, which has demonstrated significant improvements in pain and health-related quality of life in patients with knee osteoarthritis. 3) ONO-4474, a pan-tropomyosin receptor kinase inhibitor, which has shown efficacy in patients with moderate to severe knee osteoarthritis. These treatments have been evaluated in recent clinical trials and may offer effective pain relief for osteoarthritis patients.

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RTX-GRT7039 Injection for Osteoarthritis

Phase 3

Waitlist Available

Research Sponsored by Grünenthal GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to week 52

Awards & highlights

Pivotal Trial

Summary

This trial tests a special injection called RTX-GRT7039 to help reduce knee pain in people with osteoarthritis who still have pain despite usual treatments. The injection works by blocking pain signals from the knee.

Who is the study for?

Adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments can join. They must understand and agree to the trial's process. Excluded are those with severe joint damage, past knee surgery within a year, significant leg misalignment, other conditions affecting safety or results, recent participation in another drug trial, employees involved in the study, clinical hip osteoarthritis on the same side, or allergy to resiniferatoxin.

What is being tested?

The trial is testing RTX-GRT7039 against a placebo for knee osteoarthritis pain relief. Participants will receive one injection and be randomly assigned to either the treatment or placebo group without knowing which they received (double-blind). The goal is to confirm if RTX-GRT7039 is effective and safe.

What are the potential side effects?

While specific side effects of RTX-GRT7039 aren't listed here, similar treatments may cause temporary injection site reactions like pain or swelling. Allergic reactions could occur in those sensitive to components related to resiniferatoxin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Erythrocyte Indices

Secondary study objectives

Change From Baseline in 36-Item Short-Form (SF-36) Domain Scores

Change From Baseline in EuroQol-5 Dimension Health Questionnaire 5 Levels (EQ-5D-5L) Score

Pain

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RTX-GRT7039Experimental Treatment1 Intervention

Participants will receive a intra-articular injection of RTX-GRT7039 during the 52-week double-blind treatment period.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive a intra-articular injection of placebo matching RTX-GRT7039 during the 52-week double-blind treatment period.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis (OA) focus on pain relief and reducing inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin production and thus inflammation and pain. Intra-articular injections, such as corticosteroids, provide localized anti-inflammatory effects, while investigational treatments like platelet-rich plasma (PRP) aim to reduce inflammation and promote tissue repair through growth factors. Gene therapies, such as those involving TGF-beta, target cellular pathways to maintain cartilage and reduce joint degradation. Understanding these mechanisms helps OA patients and their doctors choose treatments that best address pain and inflammation, improving quality of life.

Pathophysiology and first-line treatment of osteoarthritis.