EUCTR2021-003395-13-DK进行中（未招募）1 期
A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis - Phase 2 Dose-finding Trial of PTP-001 (MOTYS) for Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, aged 40 to 80 years
- •2. Symptomatic knee OA with Kellgren-Lawrence (KL) radiographic classification of 2, 3, or 4 (mild, moderate, or severe) as assessed by the central reading facility
- •3. IF KL radiographic classification of 4 (KL 4) is assessed by the central reading facility, participant must not have prior a referral from their treating physician for arthroplasty of the target knee
- •4. Target knee pain = 20 and = 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
- •5. Onset of symptomatic OA of the target knee was at least 6 months prior to screening
- •6. Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
- •7. IF FEMALE, must meet all of the following:
- •Not breast feeding
- •Not planning to become pregnant during the study
- •If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control (See Appendix A) for at least 12 weeks after the injection
- •8. Willingness to remain on the same oral rescue” (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
- •9. Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
- •10. Written informed consent is obtained from the participant
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •- Participant is non-ambulatory (unable to walk >50 feet without assistance)
- •- Clinically severe obesity as defined by the National Institutes of Health (body mass target =40 kg/m2) at screening or baseline
- •- Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
- •- Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
- •- Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
- •- Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
- •- Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology
- •- Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
- •- Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
- •- Participant previously underwent arthroplasty of the target knee
- •13. Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
- •15. Osteonecrosis of either knee
- •16. Significant acute (within the past 3 months) injury to the target knee
研究者
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