Open-label trial to check the safety and tolerability of RTX-GRT7039 injections for pain associated with osteoarthritis of the knee.

JRCT ID: jRCT2031230069

Registered date:14/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moderate to severe pain associated with osteoarthritis of the knee
• Date of first enrollment: 18/07/2023
• Target sample size: 30
• Countries of recruitment: United States,Japan,United Kingdom,Japan,South Africa,Japan,Poland,Japan,Romania,Japan,Bulgaria,Japan,Colombia,Japan
• Study type: Interventional
• Intervention(s): RTX-GRT7039 intra-articular injection.

Outcome(s)

• Primary Outcome: 1) Incidence of treatment-emergent adverse events(TETAEs). Incidence of TETAEs leading to discontinuation. [Time Frame: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)]

Secondary Outcome

1) Incidence of TEAEs representing structural changes of the knee joint as visualized by the imaging methods (X-ray and/or magnetic resonance imaging [MRI]. [Time frame: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)]
2) Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score for the index and the non-index (where applicable) knee. [Time Frame: From baseline (assessment at Visit 2) to Visit 5]
3) Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36. [Time Frame: From baseline (assessment at Visit 2) to Visit 5]

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 severepain due to osteoarthritis of the knee.
- 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 one month.
- The subject had an injection of platelet-rich plasma into the index knee within one month.
- The subject applied topical capsaicin on the index knee within 3months.
- 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): 2021-005046-15,NCT05377489,U1111-1268-7230