Comparison of RTX-GRT7039 and placebo injections for pain associated with osteoarthritis of the knee.

JRCT ID: jRCT2031220354

Registered date:01/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Moderate to severe pain associated with osteoarthritis of the knee
• Date of first enrollment: 15/12/2022
• Target sample size: 90
• Countries of recruitment: Canada,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Italy,Japan,Mexico,Japan,Netherland,Japan,Poland,Japan
• Study type: Interventional
• Intervention(s): RTX-GRT7039 intra-articular injection.

Outcome(s)

• Primary Outcome: 1) Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score in the index knee.

Secondary Outcome

1) Change in WOMAC pain subscale score in the index knee based on the 11-point numeric rating scale (NRS).
2) Change in WOMAC physical function subscale score.
3) Incidence of treatment-emergent adverse events (TEAEs). Incidence of TEAEs leading to treatment discontinuation after the first injection.
Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI]).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- >=18 years of age at the screening visit.
- Body Mass Index (BMI) <= 40.0 kg/m2.
- Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I-III.
- Moderate to severe osteoarthritis at baseline.
- Documented history indicating that subject has insufficient pain relief with optimal standard of care (SoC).
- The investigator does not consider that any additional benefit can reasonably be expected from further adjustments to the patient's pain treatment.

Exclude criteria

- The subject had an intra-articular injection of either corticosteroid or intra-articular visco-supplementation (i.e., hyaluronic acid) into the index knee within 3 months.
-The subject had an injection of platelet-rich plasma into the index knee within 6 months.
- The subject applied topical capsaicin on the index knee within 3 months.
- Pre-existing rapidly progressing osteoarthritis (RPOA) Type I or Type II, osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, or the subject has knee pain attributable to disease other than osteoarthritis.
- Other conditions that could confound discrimination of pain assessment in the index knee.
- Clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of
the trial.
- History of severe allergic or anaphylactic reactions.
- History of significant trauma or surgery, or surgery planned during the trial period, related to the knee.

Related Information

• Primary Sponsor: Lange Bernd, MD, MSc, Medical Lead
• Secondary ID(s): 2021-005029-26,NCT05248386