930 Participants Needed

RTX-GRT7039 Injections for Knee Osteoarthritis

Recruiting at 106 trial locations
Dc
Overseen ByDirector clinical trials
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Grünenthal GmbH
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.

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.12345

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.12367

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: RTX-GRT7039Experimental Treatment1 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.

Find a Clinic Near You

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

Published Research Related to This Trial

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

Citations

Localized Injection of Streptomycin, Kenacort and Lidocaine combination for Symptomatic Pain Management of Knee Osteoarthritis. [2019]
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]
Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. [2022]
Long-term efficacy and safety of intra-articular sodium hyaluronate (Hyalgan) in patients with osteoarthritis of the knee. [2017]
Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. [2013]
Platelet Rich Plasma Injections for Knee Osteoarthritis Treatment: A Prospective Clinical Study. [2023]
Pain during walking and ascending stairs before hyaluronic acid injection was common in patients with knee osteoarthritis: a qualitative study [2021]
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