NCT01645176已完成2 期
Hydroxychloroquine/Atorvastatin in the Treatment of OA of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Synovitis
研究概览
简要总结
The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory subjects with OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days. Symptoms must include knee joint pain.
- •Male or female adults age >40 years with a body mass index <35
- •Radiographic evidence of at least one osteophyte in either knee on posteroanterior (PA) and lateral standing, flexed x-ray.
- •A Kellegren-Lawrence score of 2-3, or KL score of 1 accompanied by a clinically apparent effusion in the index knee.
- •A WOMAC pain score of >8 on the index knee at screening visit.
排除标准
- •A requirement for treatment with high potency opioids for pain relief.
- •Unwilling to abstain from NSAIDs and/or other analgesic medications except acetaminophen (i.e., COX-2 inhibitors, tramadol) for 48 hours and acetaminophen for 24 hours prior to pain assessments during the study. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
- •On an unstable dose of NSAIDs or analgesics for at least 1 months prior to screening visit
- •Using a handicap assistance device (i.e., cane, walker) >50% of the time.
- •Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening visit 1 and will not remain stable during their participation in the study.
- •Had a previous history of arthroscopic or open surgery to the index knee in the past 6 months or planned surgery during study follow up.
- •Had joint replacement surgery in the index knee.
- •Received corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening visit 1 and/or not willing to abstain from treatments for the duration of the study
- •A history in the past 5-10 years of reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
- •Clinical signs and symptoms of active knee infection or radiographic evidence of crystal disease other than chondrocalcinosis (i.e. gout).
- •A history of abnormal laboratory results >2.5 x ULN indicative of any significant medical disease, which in the opinion of the investigator, would preclude the subjects participation in the study
- •Any of the following abnormal laboratory results during screening:
- •ALT and/or AST >2.5x ULN
- •Hemoglobin <9 g/dL
- •WBC <3500 cells/mm3
- •Lymphocyte count <1000 cells/mm3
- •Serum creatinine >1.5 x ULN or calculated Glomerular filtration rate less than
- •Creatine phosphokinase level > 2x ULN
- •A history of malignancy in the past ten years (<10 years), with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
- •Significant hip pain, ipsilateral to the index knee that may interfere with assessments of index knee pain
- •A known or clinically suspected infection with human immunodeficiency virus (HIV), or hepatitis C or B viruses
- •Participated within 3 months or will participate concurrently in another investigational drug or vaccine study
- •A history of drug or alcohol dependence or abuse in the past 3 years
- •A female with reproductive capability who is unwilling to use birth control for the duration of the study and/or intends to conceive within 12 months of dosing.
- •Ongoing use of hydroxychloroquine, or any anti-malarial, or prior history of use within past 3 months or any prior history of history of allergy, hypersensitivity or toxicity to antimalarial use.
- •Ongoing use of a statin (HMG Co A reductase inhibitor), or use within past 3 months or any prior history of history of allergy, hypersensitivity, or toxicity to statin use.
- •Use of fibric acid derivative in past 3 months.
- •Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.-
研究组 & 干预措施
Hydroxychloroquine/Atorvastatin open label
Experimental
干预措施: Hydroxychloroquine/Atorvastatin (Drug)
结局指标
主要结局
Change in Synovitis
时间窗: baseline and 16 weeks
MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial \& sagittal CE-MRI sequence, while effusion \& bone marrow lesions were scored using non-CE-MRI sequences of parent study. Synovitis defined as enhancing thickened synovium (\>2 mm) \& was evaluated at nine sites of joint-medial \& lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial \& lateral perimeniscal, \& adjacent to anterior \& posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if \<2mm, grade 1 if 2-4 mm \& grade 2 if \>4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis \& \>/= 13 severe synovitis.
次要结局
未报告次要终点
研究者
Mark Genovese
Principle Investigator
Stanford University
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative ColitisUlcerative Colitis (Disorder)NCT05119140Icahn School of Medicine at Mount Sinai3
招募中
不适用
Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-AbRecurrent Pregnancy LossEuthyroid With Thyroid AntibodiesNCT06652113Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University796
Unknown
3 期
Hydroxychloroquine, Azithromycin in the Treatment of Covid-19SARS-CoV-2 PneumoniaCOVID-19NCT04405921Centre Hôpital Universitaire Farhat Hached200
进行中（未招募）
1 期
Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Nonsmall cell lung cancerPatients affected by Resectable Head and Neck (HN) cancer (only Squamous Cell Carcinoma of the oral cavity or larynx), or Resectable Non-small cell lung cancer (NSCLC, only Lung Squamous Cell Carcinoma or Adenocarcinoma).CTIS2024-516189-12-00Ospedale San Raffaele S.r.l.20
进行中（未招募）
1 期
Role of Hydroxychloroquine in therapeutic strategy of Head and Neck cancer and Non-small cell lung cancerEUCTR2021-004189-37-ITOSPEDALE SAN RAFFAELE20