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Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN (DRIP)

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Droglican
Paracetamol or oral NSAIDs excluding COX2 inhibitors
Sponsored by
Bioiberica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Femorotibial knee OA (Uni- or bilateral)
  • Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
  • Symptomatic for more than 6 months in the most painful knee
  • Radiological K&L grade II-III in radiographs from less than 12 months
  • Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (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

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, aseptic 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 24h before inclusion visit
  • 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, analgesics other than the authorized rescue treatments) which are forbidden during the trial
  • Arthroscopy in the last 6 months
  • Patients with known allergy to CS, GH, or intolerance to rescue treatment (Paracetamol 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:
  • Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or
  • 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 / Automatic Implantable Cardioverter Defibrillators / Implantable Cardioverter Defibrillators (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 / insulin pump, Metal implants; f/e screws, prostheses, piercings.
  • Claustrophobia, or serious mobility problem (Parkinson, tremors)

Sites / Locations

  • CHU BrugmannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Droglican

Control

Arm Description

Chondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg

Untreated arm

Outcomes

Primary Outcome Measures

Evaluate change of composition of cartilage trough imaging marker (dGEMRIC)
To evaluate the techniques for studying proteoglycans content: the delayed gadolinium enhanced magnetic resonance imaging of cartilage (dGEMRIC), after 6 months of treatment with DROGLICAN versus untreated control.

Secondary Outcome Measures

Consumption of Rescue Medication
Use of rescue treatments (Paracetamol or oral NSAIDs excluding COX2 inhibitors)

Full Information

First Posted
June 6, 2016
Last Updated
June 30, 2016
Sponsor
Bioiberica
Collaborators
Artialis
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1. Study Identification

Unique Protocol Identification Number
NCT02821468
Brief Title
Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN
Acronym
DRIP
Official Title
Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioiberica
Collaborators
Artialis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES study was a phase IV, double blind, randomized and non-inferiority trial to compare the efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) + chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain subscale by 50% without significant difference between groups. Further, there was no difference in all secondary outcomes assessing patient's pain, functional capacity, stiffness, inflammation, joint swelling, effusion, and overall quality of life. This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the good health of the cartilage of patients suffering of knee osteoarthritis as revealed by qualitative assessment of cartilage biochemical composition in vivo.
Detailed Description
This study is a post-marketing, open, exploratory, multicenter trial with 2 parallel-groups of patients suffering from knee OA. Investigators will be private or public hospital rheumatologists, general practitioners, or articular disease specialists located in Belgium. After evaluation by the investigator during a control visit or via on site-patient registry, potential participants will be asked to perform an inclusion visit (V1). During this visit, the investigator will assess the eligibility of the patients. Eligible patients will sign an informed consent. The investigator will make a general evaluation (demography, medical history, OA history, OA medication history, concomitant medications including "rescue treatments") and a pain evaluation. Synovial fluid will be collected in case of knee swelling. Blood samples will be collected in a preselected clinical laboratory for future biomarkers analyses. Patients will be asked to perform an MRI exam within 20 days following the inclusion visit and representing the MRI at baseline. A standard X-ray will be performed at the same imaging site if the last X-ray available is not responding to high quality standard. For DROGLICAN arm, patients will be given investigational medicinal product (IMP) for a 6-month period via the hospital pharmacy where image acquisition will be performed. IMP intake will begin right after baseline MRI acquisition. Study arm attribution will be determined according to the order of enrolment at each investigating site and using a randomization list. All study subjects (receiving DROGLICAN or untreated control) will be allowed to take paracetamol and oral NSAIDs excluding COX2 inhibitors to relief knee pain. Patients will be asked to use these "rescue medications" only when needed during the trial, beginning by Paracetamol (up to 3g/day) and NSAIDs as a second-line medication, and will be told to reduce their use if they do not feel the need for them. The use of rescue treatments during the month prior to each visit will be recorded by the investigator in a Case Report Form (CRF). All other treatments for osteoarthritis will be forbidden during the course of the study. Patients will return for consultation after 6 month (V2) and 12 months (V3). At each visit, the investigator will make a general evaluation, and will record concomitant medications including rescue medications, adverse events and drop-outs. For DROGLICAN arm, compliance to the IMP will be assessed by counting unused capsules within the investigation kit brought back by the patient. At V2, patients will be given IMP for the next 6 months. Patients will be asked to return to the investigator all unused capsules of IMP at the next visit. Blood samples and synovial fluid (if applicable) will be collected for future biomarkers analyses. MRI will be done at 6 months (V2) and optionally at 12 months (V3). Finally, an optional X-ray might be performed at V3 depending on the result of the interim analysis. Monthly phone calls will be made by the investigator to assess and encourage patient's compliance (for DROGLICAN arm), to record potential adverse event, new concomitant treatment and/or drop-off. Patients' clinical data will be recorded at each visit in a CRF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Droglican
Arm Type
Experimental
Arm Description
Chondroitin Sulfate 1,200mg + Glucosamine Hydrochoride 1,500mg
Arm Title
Control
Arm Type
Experimental
Arm Description
Untreated arm
Intervention Type
Drug
Intervention Name(s)
Droglican
Intervention Description
Combined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg
Intervention Type
Drug
Intervention Name(s)
Paracetamol or oral NSAIDs excluding COX2 inhibitors
Primary Outcome Measure Information:
Title
Evaluate change of composition of cartilage trough imaging marker (dGEMRIC)
Description
To evaluate the techniques for studying proteoglycans content: the delayed gadolinium enhanced magnetic resonance imaging of cartilage (dGEMRIC), after 6 months of treatment with DROGLICAN versus untreated control.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Consumption of Rescue Medication
Description
Use of rescue treatments (Paracetamol or oral NSAIDs excluding COX2 inhibitors)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Femorotibial knee OA (Uni- or bilateral) Responding to clinical and radiological criteria of American College of Rheumatology (ACR) Symptomatic for more than 6 months in the most painful knee Radiological K&L grade II-III in radiographs from less than 12 months Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (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 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, aseptic 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 24h before inclusion visit 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, analgesics other than the authorized rescue treatments) which are forbidden during the trial Arthroscopy in the last 6 months Patients with known allergy to CS, GH, or intolerance to rescue treatment (Paracetamol 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: Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or 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 / Automatic Implantable Cardioverter Defibrillators / Implantable Cardioverter Defibrillators (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 / insulin pump, Metal implants; f/e screws, prostheses, piercings. Claustrophobia, or serious mobility problem (Parkinson, tremors)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Herrero
Phone
+34934904908
Email
mherrero@bioiberica.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Vergés
Organizational Affiliation
Bioiberica
Official's Role
Study Director
Facility Information:
Facility Name
CHU Brugmann
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anieska GIERASIMOWICZ - FONTANA
Email
mherrero@bioiberica.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN

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