PEP and Euflexxa for Osteoarthritis
MM
SK
Overseen ByShariq Khan, M.S.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Rion Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have had steroid or viscosupplement injections in the last 3 months, or PRP injections in the last 6 months, you may not be eligible to participate.
Are You a Good Fit for This Trial?
This trial is for individuals with knee osteoarthritis. Participants should be adults who are experiencing symptoms and have not found relief from other treatments. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline the severity of osteoarthritis, age range, overall health status, and any medications or conditions that might interfere with the trial.Inclusion Criteria
I have had daily knee pain for over 6 months, scoring between 30 to 80 out of 100.
I am seeking injection therapy for pain relief.
Ability to comply with protocol
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Exclusion Criteria
I have not had a knee cleaning surgery in the last 6 months.
Concurrent participation in another investigational drug or device study or participation in the last 30 days prior to enrollment
I do not have severe nerve, heart, lung, or rheumatic diseases affecting my daily activities.
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single intra-articular injection of PEP, with or without EUFLEXXA, at low or high doses
1 day
1 visit (in-person)
Primary Safety Follow-up
Participants are monitored for safety through the occurrence of DLTs for 90 days post-injection
90 days
Long Term Safety Follow-up
Participants are monitored for long-term safety from Day 91 to Day 365 post-injection
275 days
What Are the Treatments Tested in This Trial?
Interventions
- PEP
- PEP/Euflexxa
Trial Overview The study is testing single intra-articular injections (directly into the knee joint) of a product called PEP at two different doses: low (one vial) and high (two vials). It's also looking at PEP combined with EUFLEXXA to see if they're safe and potentially effective in treating knee osteoarthritis.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: 2b PEP-EUFLEXXA High DoseExperimental Treatment1 Intervention
2B PEP-EUFLEXXA High Dose
Group II: 2a PEP-EUFLEXXA Low DoseExperimental Treatment1 Intervention
2A PEP-EUFLEXXA Low Dose
Group III: 1B PEP High DoseExperimental Treatment1 Intervention
1B PEP High Dose in Saline
Group IV: 1A PEP Low DoseExperimental Treatment1 Intervention
1A PEP Low Dose in Saline
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rion Inc.
Lead Sponsor
Trials
4
Recruited
260+
Caidya Clinical Research Organization
Collaborator
Trials
1
Recruited
20+
Published Research Related to This Trial
Etanercept is effective in treating juvenile idiopathic arthritis (JIA) categories such as extended oligoarthritis, enthesitis-related arthritis, and psoriatic arthritis, showing significant improvement in disease activity scores over 3 to 24 months in a study of 1,678 patients.
While etanercept is generally safe, there is an increased risk of serious and non-serious adverse events, particularly uveitis flares and reports of chronic inflammatory bowel disease in patients with these JIA categories, indicating the need for careful monitoring.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis.Windschall, D., Müller, T., Becker, I., et al.[2021]
Celecoxib is associated with a slightly increased risk of certain adverse events, such as edema, hypertension, angioedema, and allergic reactions compared to placebo, but these risks are relatively small.
In contrast, celecoxib shows a lower risk of gastrointestinal issues like hemorrhage and ulceration compared to non-selective NSAIDs, suggesting it may be a safer option for patients concerned about GI side effects.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials.Essex, MN., Zhang, RY., Berger, MF., et al.[2022]
Citations
A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). [2019]
Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. [2021]
The German etanercept registry for treatment of juvenile idiopathic arthritis. [2018]
A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. [2020]
Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. [2022]
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