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

NCT04318041 | Recruiting Phase 3

• 1 other identifier: DAR-THA-19-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Cartilage volume measured by MRI of the affected knee.

  Cartilage volume in cc

  Change from Day 0 cartilage volume at Day 336, Day 672

• Bone marrow lesions measured by MRI of the affected knee.

  Bone marrow lesions in mm3

  Change from Day 0 Bone marrow lesions at Day 336, Day 672

• Synovitis measured by MRI of the affected knee.

  Synovial tissue volume in mm3

  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)

  Joint space width in mm

  Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672

Secondary Outcomes (8)

• 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

Study Arms (2)

diacerein (Artrodar)

EXPERIMENTAL

Drug: Artrodar

placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Artrodar DRUG

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

diacerein (Artrodar)

Placebos DRUG

Placebo: D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal

placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• TRB Chemedica: lead

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

diacerein

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nipaporn Jitsook

  TRB Chemedica

  STUDY DIRECTOR

Central Study Contacts

Juree Patarasuwankul

CONTACT

+66 (0)2 264 20 10; juree.p@trbchemedica.co.th

Waraporn Sanguanworapong

CONTACT

+66 (0)2 2642010; waraporn.s@trbchemedica.co.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, hospital pharmacists and monitors are blind to the treatment. The analysis of the results will be performed blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 23, 2020
• Study Start: November 22, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)