Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Synovitis measured by MRI of the affected knee.
研究概览
简要总结
This study evaluates the structure-modifying effect of Diacerein (Artrodar ®) in knee osteoarthritic (OA) patients by measuring total cartilage volume from magnetic resonance imaging (MRI) of the knee. Half of participants will receive Diacerein (Artrodar ®), while the other half will receive a placebo.
详细描述
Diacerein (Artrodar ®) participants take 1x1 with evening meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study). Placebo participants take 1x1 with evening meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator, hospital pharmacists and monitors are blind to the treatment. The analysis of the results will be performed blind.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
- •Grade II-III OA severity that classified by the Kellgren-Lawrence classification
- •Varus malalignment ≤ 15°
- •Body mass index (BMI) ≤ 30 kg/m2
- •Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
- •Evidence of adequate contraceptive methods in women of childbearing age
排除标准
- •Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
- •Intra-articular treatment with any product (corticosteroids in the last 3 months, glycosaminoglycans, hyaluronic acid in the last 6 months, etc.), joint lavage or arthroscopic procedures within 6 months before the start of the study
- •Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
- •Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
- •Poor general health or other conditions which would make regular hospital attendance difficult
- •Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
- •Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
- •Evolving arthritis requiring surgery within the coming year;
- •Persistent diarrhoea (> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
- •Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
- •Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
- •Hepatic disease (transaminases > 2.5 x upper limit of normal values (ULN) or total bilirubin > 2 x ULN) or history of alcoholism and liver disease
- •Severe parenchymal organ disease
- •History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
- •Patient with diabetes mellitus (DM) who has heamoglobin A1c level > 8%
- •Patient with hypertension who has systolic blood pressure > 150 mmHg or diastolic Blood pressure > 95 mmHg
- •Pregnancy or lactation
- •Participation in a drug clinical trial within the 3 months before the start of the study;
- •Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
- •Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
- •Knee size measured at lower thigh > 50 cm
研究组 & 干预措施
diacerein (Artrodar)
干预措施: Artrodar (Drug)
placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Synovitis measured by MRI of the affected knee.
时间窗: Change from Day 0 Synovial tissue volume at Day 336, Day 672
Synovial tissue volume in mm3
Cartilage volume measured by MRI of the affected knee.
时间窗: Change from Day 0 cartilage volume at Day 336, Day 672
Cartilage volume in cc
Bone marrow lesions measured by MRI of the affected knee.
时间窗: Change from Day 0 Bone marrow lesions at Day 336, Day 672
Bone marrow lesions in mm3
Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position)
时间窗: Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672
Joint space width in mm
次要结局
- Physician and Patient's global assessment(Day 168, Day 336, Day 672)
- Rescued medicine consumption(Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- Pain at rest(Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- Pain on walking at 15 meters(Day -7 to -30, Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- KOOs(Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- EQ5D5L(Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- Time up-and-go test(Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)
- Oxford Knee Questionnaire(Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672)