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Monoclonal Antibodies

RTX-GRT7039 Injections for Knee Osteoarthritis

Phase 3
Recruiting
Research Sponsored by Grünenthal GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant is 18 years of age or older at the Screening Visit.
The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to week 78
Awards & highlights

Study Summary

This trial will evaluate the safety of knee injections to treat the pain of osteoarthritis.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this summary focuses on safety and tolerability, potential side effects may include reactions at the injection site, general discomfort or pain increase in the knee, or other unforeseen responses related to RTX-GRT7039.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with knee osteoarthritis and can still perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to week 78
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to week 78 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
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
Change From Baseline in Patient-Specific Functional Scale (PSFS)
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RTX-GRT7039Experimental Treatment1 Intervention
Participants will receive up to 5 intra-articular 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 Location

Who is running the clinical trial?

Grünenthal GmbHLead Sponsor
97 Previous Clinical Trials
33,138 Total Patients Enrolled
12 Trials studying Osteoarthritis
8,328 Patients Enrolled for Osteoarthritis

Media Library

RTX-GRT7039 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05377489 — Phase 3
Osteoarthritis Research Study Groups: RTX-GRT7039
Osteoarthritis Clinical Trial 2023: RTX-GRT7039 Highlights & Side Effects. Trial Name: NCT05377489 — Phase 3
RTX-GRT7039 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377489 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to register for this medical study?

"According to clinicaltrials.gov, this medical trial is actively seeking participants. It was initially uploaded on August 26th 2022 and has been modified as recently as June 29th 2023."

Answered by AI

How extensive is the patient population for this clinical investigation?

"To execute this experiment, Grünenthal GmbH will require 930 participants that qualify based on the selection criteria. Two of the locations they are recruiting from include Arizona Arthritis and Rheumatology Associates (AARA) P.C in Glendale, Arizona as well as Elite Clinical Studies, LLC found in Phoenix, California."

Answered by AI

How many sites are overseeing the management of this research endeavor?

"The present research is recruiting participants at Arizona Arthritis and Rheumatology Associates (AARA) P.C in Glendale, Elite Clinical Studies, LLC in Phoenix, California and Orange County Research Institute in Anaheim alongside 84 other medical sites."

Answered by AI

Has RTX-GRT7039 been given the green light from the FDA?

"The team at Power evaluated RTX-GRT7039's safety level as a 3 due to its designation as Phase 3 trial, suggesting evidence of efficacy and multiple confirming rounds of data regarding the drug's safety."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What site did they apply to?
Arizona Arthritis and Rheumatology Associates (AARA) P.C
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee
2022. "Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377489.
All > Osteoarthritis
~121 spots leftby Aug 2024
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