EUCTR2019-004515-31-DK进行中（未招募）1 期
A Phase 2b Trial of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
ordic Bioscience Clinical Development A/S0 个研究点目标入组 278 人开始时间: 2019年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 278
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.Subject is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, and is willing to provide information at the scheduled evaluations, and appropriate written informed consent has been obtained.
- •2.Males and females age = 40 years to = 85 years.
- •3.Body mass index = 45 kg/m2 .
- •4.Knee pain score of at least 20 out of 50 in response to the WOMAC A pain questionnaire (5 questions) at both the screening and the baseline visits.
- •5.Femorotibial osteoarthritis of the target knee, according to the American College of Rheumatology (ACR) clinical and radiographic criteria.
- •6.Radiological OA grade 2 or 3, of either medial and/or lateral compartment of the target knee of the Kellgren-Lawrence method(Kellgren and Lawrence 1957) by X-ray obtained during screening, or on a recent (within 6 months) X-ray image, which fulfills the specifications for central reading.
- •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 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
排除标准
- •1.Previous treatment with SB-061.
- •2.Known hypersensitivity to or previous hypersensitivity reactions to protein-based medication, or any impediment to intra-articular injections.
- •3.Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 3 months of screening.
- •4.High dose (equivalent to >10mg of prednisone/day) systemic corticosteroid treatment of longer (>14 days) duration during the past 6 months prior to screening.
- •5.Regular treatment with any Chondroitin Sulfate-containing product within the past 7 days prior to Baseline.
- •6.Previous procedures affecting joint homeostasis including total meniscectomy or septic arthritis or any other serious condition leading to secondary OA of the target knee.
- •7.Major surgery or arthroscopy of the target knee within the previous year prior to screening.
- •8.Known rapid progressive disease in the target knee defined as joint space narrowing >1.2 mm/year.
- •9.Planned surgery in the target knee within the next 3 months.
- •10.Chronic concomitant treatment with an oral or parenteral anti-coagulant including heparin or warfarin or derivatives thereof.
- •11.Use of an investigational drug, device, or biologic within 6 months prior to screening.
- •12.Presence of concomitant inflammatory disease affecting either knee, such as rheumatoid arthritis, psoriasis, gout, or active infection, including bacterial skin-lesions affecting the leg of the target knee.
- •13.Severely uncontrolled diabetes mellitus, diabetic neuropathy, infections, complications, or any end-stage organ disease, in the opinion of the investigator.
- •14.Current immunosuppressive therapy.
- •15.Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
- •16.Current malignancy or treatment for malignancy within the past five years, with the exception of non-melanoma skin cancer, or carcinoma in situ events.
- •17.For women of childbearing potential:
- •(a)Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
- •(b)Failure to agree to practice a highly effective method of contraception (see Section 4.4), from enrollment up to at least 3 months after the study end.
- •18.For sexually active men with a female partner of childbearing potential: failure to agree to use condom (see Section 4.5) from enrollment up to at least 3 months after the study end.
- •19.Any other abnormal laboratory results or significant medical conditions that the Investigator believes should preclude the subject’s participation in the trial.
研究者
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