2023-509937-37-00已完成2 期
A 5- year randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- Change from baseline in the knee structure
研究概览
简要总结
To evaluate knee structural changes from baseline in the central medial tibiofemoral compartment (cMTFC) of LNA043 compared with placebo in the target knee at Week 104.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females between 40 and 75 years of age
- •Body mass index (BMI) < 40 kg/m2
- •Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
- •Radiographic disease K-L grade 2 or 3 knee OA with predominantly medical TFC involvement defined as medial Joint Space Narrowing (medJSN) 1-2 and medJSN> lateral Joint Space Narrowing (latJSN) in the target knee
- •Participants with WOMAC pain of 20-45 (out of 50) for the target knee at both (double baseline) assessments during screening period after discontinuation of analgesics, anti-inflammatories and low potency opioids within 48 hours an equivalent of 5xT ½ wash out period (whichever is longer)
- •Symptomatic OA with pain in the target knee for at least 6 months
- •Primary source of pain throughout body is due to OA in the target knee: Widespread Pain Index score of ≤6 and a Symptom Severity score of < 7
排除标准
- •Participants with radiographic knee OA K-L grade = 4 on the non-target knee
- •Other pain conditions that could confound assessments of the pain associated with knee OA, as judged by the Investigator
- •Participants with WOMAC Pain >15 (out of 50)v in the non-target knee
- •Severe malalignment (>7.5 ° varus or valgus) in the anatomical axis of the target knee
- •Clinical signs of moderate- severe inflammation (i.e., redness, warmth, effusion) of the target knee or requiring aspiration in the target knee within 12 weeks prior Screening
- •Arthroscopy of the target knee within the 6 months prior to Screening
- •Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy, partial or complete joint replacement or planned knee surgery for either knee during the study
- •Unstable target knee joint (including, but not limited to, posttraumatic or congenital laxity) or insufficiently reconstructed ligaments based on medical history and/or physical examination by the Investigator
- •Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute in less than 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors, and/or patellofemoral dysplasia based on clinical assessment, X-ray or MRI
- •Symptomatic hip OA on either hip or hip prosthesis recently implanted (within 1 year) or foreseen within the study period (either hip)
结局指标
主要结局
Change from baseline in the knee structure
Change from baseline in the knee structure
次要结局
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function
- Change from baseline in cartilage structure
- Change from baseline in physical function
- Proportion of participants demonstrating structural progression
- Assessing adverse events and serious adverse events
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (22)
Loading locations...
相似试验
进行中（未招募）
不适用
In vivo study of a medial stabilizing total knee replacement for analysis of postoperative knee stability and patient satisfactioM17Gonarthrosis [arthrosis of knee]DRKS00013308abor für Biomechanik & Experimentelle OrthopädieKlinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation, Klinikum der Universität München, LMU München12
已完成
不适用
A randomised controlled trial of different knee prosthesesPrimary knee replacement surgeryMusculoskeletal DiseasesISRCTN45837371Department of Health (UK)2,450
已完成
不适用
Randomised controlled trial to assess an all-polyethylene tibia medial rotation knee implant compared to a metal-backed tibia implantPatients undergoing total knee arthroplasty for any indication.Musculoskeletal DiseasesTotal knee arthroplastyISRCTN12532998MatOrtho Limited162
招募中
4 期
IDENTIFICATION OF SYNOVIAL BIOMARKERS OF RESPONSE TO IXEKIZUMAB IN REFRACTORY PSORIATIC ARTHRITIS: THE PRECISE STUDY.PSORIATIC ARTHRITIS2025-521259-21-00University Hospital Of Ferrara30
招募中
3 期
A study to evaluate the efficacy and safety of Clascoterone solution in treatment of male pattern hair loss.Androgenetic Alopecia2023-504421-39-00Cassiopea S.p.A.629