Evaluation of the evolution of imaging markers (using Magnetic Resonnance Imaging) of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study

Phase 1

• Conditions: Knee Osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-005681-37-BE
• Lead Sponsor: BIOIBERICA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• Male or female = 40 years of age with BMI = 40
• Femorotibial knee OA (Uni- or bilateral)
o Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
o Symptomatic for more than 6 months in the most painful knee
o Radiological K&L grade II-III in radiographs from less than 12 months
• Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) = 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
• Able to follow the instructions of the study
• Having signed an informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Related to the OA pathology
• Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
• Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aspectic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
• Radiological K&L grade I or IV
• Prosthesis in the target knee

Related to treatments
• Analgesics to manage OA knee pain (Paracetamol, oral NSAIDs, etc.) 24h before inclusion and any follow-up visits
• Corticosteroids injection in the target knee in the month preceding inclusion
• Hyaluronan injection in the target knee in the last 6 months
• Oral corticotherapy = 5mg/day in the last 3 months
• Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
• An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy) which are forbidden during the trial
• Arthroscopy in the last 6 months
• Patients with known allergy to CS, GH, or intolerance to rescue treatments (Paracetamol, tramadol and NSAIDs)
• Patients with allergy to shellfish

Related to associated diseases
• Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….)
• Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee

Related to patients
• Artialis (study coordinator) or Bioiberica (Sponsor) ‘s employees
• Participation to a therapeutic clinical trial in the last 3 months
• Under guardianship or judicial protection
• Pregnancy, breastfeeding, planned conception
• Women without menopause or tubal ligation and without contraception

Related to MRI
• Unable to receive gadopentetate contrast agent injection because of contraindications:
o Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or
o Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
• Known anaphylactic reactions to Gadolinium or related substances
• Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
• Claustrofibia, or serious mobility problem (Parkinson, tremors)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the evolution of dGEMRIC imaging marker after 6 months of treatment with DROGLICAN®;<br> Secondary Objective: • Use of rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors)<br> • Option: evolution of dGEMRIC imaging marker after 12 months of treatment with DROGLICAN®<br> • Option: evolution of cartilage and bone parameters (volume, thickness, curvature, lesions, etc.) after 6 and 12 months of treatment with DROGLICAN®<br> • Option : evolution of Joint Space Width (JSW)after 12 months of treatment with DROGLICAN®<br> • Tolerance<br> • Compliance<br> ;Primary end point(s): dGEMRIC index;<br> Timepoint(s) of evaluation of this end point: V0 = Inclusion visit<br> V1 = After 6 months of treatment<br> V2 = After 12 months of treatment (option)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Timepoint(s) of evaluation of this end point: V0 = Inclusion visit<br> V1 = After 6 months of treatment<br> V2 = After 12 months of treatment<br> ;<br> Secondary end point(s): • Option: cartilage/bone parameters (volume, thickness, curvature, lesions, etc.)<br> • Option : radiographic JSW<br> • Adverse events and drop-out<br> • Rescue treatments (Paracetamol, tramadol and oral NSAIDs excluding COX2 inhibitors)<br> • Pill count and compliance assessment by phone call<br>