jRCT2031230069招募中不适用
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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 主要终点
- Incidence of treatment-emergent adverse events(TETAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •>=18 years of age at the screening visit.
- •Body Mass Index (BMI)=< 40.0 kg/m
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of treatment-emergent adverse events(TETAEs)
时间窗: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)
Incidence of TETAEs
Incidence of TETAEs leading to discontinuation
时间窗: From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial)
Incidence of TETAEs leading to discontinuation
次要结局
- Incidence of TEAEs representing structural changes of the knee joint(From baseline (assessment at Visit 2) to Visit 8 or 9 (end of trial))
- Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function and pain subscale score(From baseline (assessment at Visit 2) to Visit 5)
- Change in QoL as assessed by questionnaires EQ-5D-5L and SF-36(From baseline (assessment at Visit 2) to Visit 5)
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