Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Artrodar
  Diacerein (Artrodar): D1-D28 (1 month): Artrodar (50 mg) 1 x 1 with evening meal D29-end of study (23 months): Artrodar (50 mg) 1 x 2 with meal
• Препарат Placebos
  Placebo: D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal

Первичные конечные точки

• Cartilage volume measured by MRI of the affected knee. [Срок оценки: Change from Day 0 cartilage volume at Day 336, Day 672]
• Bone marrow lesions measured by MRI of the affected knee. [Срок оценки: Change from Day 0 Bone marrow lesions at Day 336, Day 672]
• Synovitis measured by MRI of the affected knee. [Срок оценки: Change from Day 0 Synovial tissue volume at Day 336, Day 672]
• Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position) [Срок оценки: Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672]

Вторичные конечные точки (8)

• Pain at rest [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672]
• EQ5D5L [Срок оценки: 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 [Срок оценки: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672]
• Physician and Patient's global assessment [Срок оценки: Day 168, Day 336, Day 672]
• Rescued medicine consumption [Срок оценки: Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672]
• Oxford Knee Questionnaire [Срок оценки: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Siriraj Hospital — Bangkoknoi

Идентификаторы

NCT: NCT04318041 · DAR-THA-19-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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