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RTX-GRT7039 for Osteoarthritis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Accellacare South London, Orpington, United KingdomOsteoarthritisRTX-GRT7039 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests if a single injection of a new drug can reduce pain from knee osteoarthritis when other treatments fail.

Eligible Conditions
  • Osteoarthritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 13 Secondary · Reporting Duration: From Baseline up to Week 52

Week 12
Erythrocyte Indices
Week 52
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
Pain
Change from Baseline in WOMAC Physical Function Subscale Score
Change from Baseline in WOMAC Stiffness Subscale Score
Change from Baseline in WOMAC Total Score
Number of Participants Reporting Durability of Effect
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score
Degenerative polyarthritis
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC A1 (Walking Pain) Subscale Score
Percentage of Participants With at Least 30%, 50% and 70% Reduction From Baseline in WOMAC Pain Subscale Score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Autologous Adipose Derived Mesenchymal Stromal Cells
1
Remestemcel-L
2
Dextrose prolotherapy (DPT)

Trial Design

2 Treatment Groups

RTX-GRT7039
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: RTX-GRT7039 · Has Placebo Group · Phase 3

RTX-GRT7039
Drug
Experimental Group · 1 Intervention: RTX-GRT7039 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to week 52

Who is running the clinical trial?

Grünenthal GmbHLead Sponsor
95 Previous Clinical Trials
33,304 Total Patients Enrolled
12 Trials studying Osteoarthritis
8,808 Patients Enrolled for Osteoarthritis

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You haven't been able to manage your pain with standard treatments in the past.

Who else is applying?

What state do they live in?
Florida100.0%
What site did they apply to?
Well Pharma Medical Research, Corp.100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
1100.0%
References

Frequently Asked Questions

Has the drug RTX-GRT7039 been authorized by the United States Food and Drug Administration?

"The safety of RTX-GRT7039 is assessed as a 3 due to the prior clinical data gathered in Phase 3 trials that demonstrate efficacy and back up its overall security." - Anonymous Online Contributor

Unverified Answer

Are there a multitude of healthcare facilities running this investigation within the state?

"Presently, the trial is being administered from 25 separate clinics. These sites are spread across Cerritos, Santa Barbara and Miami in addition to 22 other locations. For participants' convenience, it is advisable that they select a clinic closest to them when enrolling as this will reduce travel costs." - Anonymous Online Contributor

Unverified Answer

How many participants can this experiment accommodate?

"Grünenthal GmbH, the trial's sponsor, requires 450 participants that meet their study criteria to run it successfully. The clinical research will be conducted at Tucson Orthopaedic Research Center in Cerritos, California and Core Health Care Group located in Santa Barbara, Florida." - Anonymous Online Contributor

Unverified Answer

Is this trial currently accepting new participants?

"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial is looking for volunteers, with the original posting date on August 26th 2022 and a recent update on February 23rd 2023. 450 individuals are desired across 25 sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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