RTX-GRT7039 Injections for Knee Osteoarthritis

Recruiting at 106 trial locations

Overseen By Director clinical trials

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Grünenthal GmbH

Disqualifiers: Joint replacement, Significant trauma, Hip osteoarthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

930 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment RTX-GRT7039 for knee osteoarthritis?

The research on similar treatments, like intra-articular injections of sodium hyaluronate and triamcinolone hexacetonide, shows they can help reduce pain and improve function in knee osteoarthritis. This suggests that RTX-GRT7039 might also be effective for this condition. ^{1 2 3 4 5}

How is the treatment RTX-GRT7039 different from other treatments for knee osteoarthritis?

RTX-GRT7039 is unique because it is a specific injection treatment for knee osteoarthritis, which may involve a novel mechanism or formulation not covered by existing studies on regenerative injection therapy, triamcinolone hexacetonide, hyaluronic acid, or platelet-rich plasma injections. However, the exact details of how RTX-GRT7039 works or its specific benefits compared to these treatments are not provided in the available research. ^{2 3 5 6 7}

What is the purpose of this trial?

This trial uses knee injections called RTX-GRT7039 for patients with knee osteoarthritis who still have pain despite usual treatments. The injections aim to reduce knee pain, possibly by affecting pain pathways or inflammation.

Eligibility Criteria

This trial is for adults over 18 with knee osteoarthritis who haven't found pain relief from standard treatments. They must be able to consent to the study and have a functional capacity class of I to III, based on specific medical criteria.

Inclusion Criteria

My previous treatments did not relieve my pain.

I have been diagnosed with knee osteoarthritis and can still perform daily activities.

The participant has given written informed consent to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of RTX-GRT7039 into the affected knee(s)

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Treatment Details

Interventions

• RTX-GRT7039

Trial Overview The trial is testing RTX-GRT7039 injections for knee pain due to osteoarthritis. It's an open-label, single-arm study where all participants receive the treatment to assess its safety and tolerability.

Participant Groups

Group I: RTX-GRT7039 Experimental Treatment 1 Intervention

Participants will receive injections of RTX-GRT7039 into either the index knee (affected knee or in case of bilateral OA the knee with highest pain intensity), or each of both knees up to Week 52.

Who Is Running the Clinical Trial?

Grünenthal GmbH

Lead Sponsor

Trials

99

Recruited

34,200+

Gabriel Baertschi

Grünenthal GmbH

Chief Executive Officer since 2016

Biology degree from the University of Neuchâtel

Prof. Dr. Uli Brödl

Grünenthal GmbH

Chief Medical Officer

MD from Ludwig-Maximilians University Munich

Findings from Research

A single injection of triamcinolone hexacetonide (THA) significantly improved patient-reported outcomes and pain relief in knee osteoarthritis (OA) patients, with 78% reporting improvement at week 1 compared to 49% in the placebo group.

The effectiveness of THA was particularly enhanced in patients with joint effusion and those who had synovial fluid aspirated during the injection, indicating that these factors may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Gaffney, K., Ledingham, J., Perry, JD.[2022]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Localized Injection of Streptomycin, Kenacort and Lidocaine combination for Symptomatic Pain Management of Knee Osteoarthritis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of the symptomatic and structural efficacy of a new hyaluronic acid compound, NRD101, in comparison with diacerein and placebo in a 1 year randomised controlled study in symptomatic knee osteoarthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of intra-articular sodium hyaluronate (Hyalgan) in patients with osteoarthritis of the knee. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Platelet Rich Plasma Injections for Knee Osteoarthritis Treatment: A Prospective Clinical Study. [2023]

7. Turkey pubmed.ncbi.nlm.nih.gov

Pain during walking and ascending stairs before hyaluronic acid injection was common in patients with knee osteoarthritis: a qualitative study [2021]