CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 714 enrolled
Drug / intervention
RTX-GRT7039drug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class I to III
  • ✓Age 18 years or older
  • ✓Documented history of insufficient pain relief with previous Standard of Care
Key exclusion· 8
  • ✕Prior joint replacement surgery of the index knee
  • ✕Significant trauma or surgery to the index knee within 12 months of screening
  • ✕Periarticular pain at the index knee from causes other than osteoarthritis (e.g., bursitis, tendonitis, referred pain)
  • ✕Clinical hip osteoarthritis on the side of the index knee

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05377489
NCT05377489Phase 3Completed
CompareCT.gov

A Single-arm, Open-label, Phase III Trial to Evaluate the Safety and Tolerability of Intra-articular Injections of RTX-GRT7039 in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee.

Grünenthal GmbH·interventional·Posted May 17, 2022·Updated Mar 12, 2026

In Brief

A Phase 3 clinical trial evaluating RTX-GRT7039 for Osteoarthritis. Completed, enrolled 714 participants across 96 sites in 7 countries.

Detailed Summary

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesBulgaria, Japan, Poland, Romania, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 17, 2022
Enrollment StartSep 15, 2022
Primary CompletionMay 15, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.1 years ago

Interventions

RTX-GRT7039drug

RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.