2025-524885-12-00撤回2 期
Repurposed Drug Evaluation for Biological Aging, Pain, and Inflammation Reduction in Osteoarthritis
Radboud universitair medisch centrum Stichting1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in epigenetic and biological age acceleration before and after medication use.
研究概览
简要总结
The main objective of this trial is to evaluate the potential of existing 2-drug combinations on slowing epigenetic and biological age acceleration in patients with knee osteoarthritis (OA).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥18 and <80
- •Radiological diagnosis of knee osteoarthritis according to their general practitioner and/or medical specialist (e.g. orthopaedic surgeon, rheumatologist), with a KL grade ≥
- •Ability to swallow and retain oral medication
排除标准
- •Known allergy or hypersensitivity to any of the medications or their excipients in the clinical trial (baricitinib, dolutegravir, metformin, colchicine)
- •Received vaccination within two weeks before the start of the study.
- •Peripheral neuritis, myositis or marked myo-sensitivity to statins.
- •Male participants not willing to use effective contraception during the study to prevent pregnancy
- •Using medications that are substrates of OCT2, inhibitors of OCT1, inducers of OCT1, inhibi-tors of OCT2, inducers of OCT2, strong CYP3A4 inhibitors, strong CYP3A4 inducers, , strong OAT3 inhibitors, substrates of Pgp, and/or substrates of BCRP. A non-exhaustive list of such medications is given below; fampridine (or dalfampridine); macrolide antibiotics (i.e. eryth-romycin, azithromycin); probenecid ;antimycotics (i.e. ketoconazole, fluconazole, itracona-zole, posaconazole and voriconazole); antimycobacterials (rifabutin, rifampicin); anticon-vulsants (carbamazepine, oxcarbazepine, phenytoin, phenobarbital); protease inhibitors & anti-retroviral drugs (i.e. boceprevir, nelfinavir ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat); anti-arrhythmic drugs (i.e. verapamil, dilti-azem); immunosuppressants (i.e. cyclosporine); hepatitis C drug telaprevir; atypical antide-pressant nefazodone and herbal product St. John’s wort.
- •Other known medical diseases that may affect joints.
- •Known generalized pain syndromes such as fibromyalgia.
- •High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years.
- •Current enrollment in another trial.
- •Incapacitated patients.
- •Pregnant or breastfeeding females.
- •A planned surgery under general, spinal, or epidural anesthesia.
- •Fertile female participants not taking sufficient contraception.
- •Having had a diagnosis of depression.
- •Immunodeficiencies and autoimmune diseases.
- •Acute and unstable heart failure.
- •Alcohol addiction (i.e. >14 units per week).
- •Current or past long-time smokers (i.e. one or more cigarettes per day).
- •Having had hepatitis B or tuberculosis.
- •Having had cancer.
- •A planned imaging procedure involving the intravascular administration of iodinated contrast agents
- •Having had Herpes zoster.
- •Any type of acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis).
- •Having had venous thromboembolism.
- •Current use of one or more of the study medications for any indication (baricitinib, dolutegravir, metformin, colchicine).
- •Moderate or severe renal impairment (eGFR<50mL/min/1.73m2)
- •Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (up-per limit of normal).
- •Abnormal lymphocyte or neutrophil counts or haemoglobin levels (Lymphocyte counts <0.5 * 10^9/ul, or neutrophil counts < 1 * 10^9/µL or haemoglobin <8 mmol/L for men and <7 mmol/L for women).
- •Use of systemic immunomodulatory drugs: steroids, anti-inflammatory biological treatments (e.g., anti-cytokine monoclonal antibodies).
- •Acute or active illness within two weeks before the start of the study.
研究组 & 干预措施
METFORMINE HCL SANDOZ 500 MG, filmomhulde tabletten
Test
干预措施: METFORMINE HCL SANDOZ 500 MG, filmomhulde tabletten (Drug)
Colchicine CF 0,5 mg, tabletten
Test
干预措施: Colchicine CF 0,5 mg, tabletten (Drug)
Olumiant 2 mg film-coated tablets
Test
干预措施: Olumiant 2 mg film-coated tablets (Drug)
Tivicay 50 mg film-coated tablets
Test
干预措施: Tivicay 50 mg film-coated tablets (Drug)
结局指标
主要结局
Change in epigenetic and biological age acceleration before and after medication use.
Change in epigenetic and biological age acceleration before and after medication use.
次要结局
- Change in inflammatory proteins and cytokines in the circulation before and after medication use.
- Change in pain severity and the knee osteoarthritis biomarkers in the blood and urine before and after medication use.
- Safety of the drug combinations assessed by the proportion of treatment emergent adverse events and grade 3/4 laboratory abnormalities.
研究者
Calin Popa
Scientific
Radboud universitair medisch centrum Stichting
研究点 (1)
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