Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Iracross
Iraline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Aged between 40 and 80 years
- Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III);
- Ambulant without assistance;
- Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
- VAS knee pain ≥40 at screening and 30 days before;
- At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
- Signed Informed consent
Exclusion Criteria:
- Unstable knee;
- Varus or valgus ≥ 15 degrees;
- Active malignancy;
- Knee trauma or lose body parts 1 year before screening;
- Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
- Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
- Intra-articular HA or corticosteroid injection within 6 months before screening;
- Arthroscopic or knee open surgery within 12 months before screening;
- Body Mass Index (BMI) ≥ 40 kg/m2;
- Active infection around the injection site;
- Use of anticoagulants or history of thrombocytopenia;
- Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
- Known sensitivity to HA or DVS;
- Pregnancy, breast feeding.
Sites / Locations
- Fizio Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iracross
Iraline
Arm Description
1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml).
1 course of IRALINE (linear 2% Hyaluronic Acid); each course consists of 3-5 intra-articular administrations (2ml) at weekly intervals (from week 1 to 3, 4 or 5, depending on each patient's need)
Outcomes
Primary Outcome Measures
Change in Range Of Motion and Visual Analogue Scale
Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days
Secondary Outcome Measures
Physician Efficacy Global Evaluation
Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy
Visual Analogue Scale Evaluation
VAS for pain (on moving and on pressing). Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.
Knee injury and Osteoarthritis Outcome Score
Changes in KOOS score from first visit to final visit. The min value is 0 and the max value 100, were the min value represents no problem and max value represents extreme problems
NSAID consumption
Incidence of NSAID consumption from first visit to final visit
Full Information
NCT ID
NCT04574453
First Posted
September 28, 2020
Last Updated
April 9, 2021
Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
1. Study Identification
Unique Protocol Identification Number
NCT04574453
Brief Title
Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
Official Title
A Randomized, Open Label, Paralel Goup Study To Assess With A Non- Inferiority Hypothesis The Efficacy And Safety Of The Medical Device Iracross (Crosslinked 2% Hyaluronic Acid) Versus The Medical Device Iraline (Linear 2% Hyaluronic Acid), Administered Intra-Articular To Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical activity history to athletes).
Detailed Description
After giving their consent, subjects will undergo a screening visit to determine eligibility for study entry. After randomization, subjects will have administered medical device Iracross or Iraline. For subjects allocated to Iracross, medical device will be administered only at first visit and for subjects allocated to Iraline, medical device will be administered at visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iracross
Arm Type
Experimental
Arm Description
1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml).
Arm Title
Iraline
Arm Type
Active Comparator
Arm Description
1 course of IRALINE (linear 2% Hyaluronic Acid); each course consists of 3-5 intra-articular administrations (2ml) at weekly intervals (from week 1 to 3, 4 or 5, depending on each patient's need)
Intervention Type
Device
Intervention Name(s)
Iracross
Intervention Description
Administration of max 2ml of Iracross at first visit
Intervention Type
Device
Intervention Name(s)
Iraline
Intervention Description
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
Primary Outcome Measure Information:
Title
Change in Range Of Motion and Visual Analogue Scale
Description
Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Physician Efficacy Global Evaluation
Description
Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy
Time Frame
180 days
Title
Visual Analogue Scale Evaluation
Description
VAS for pain (on moving and on pressing). Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.
Time Frame
180 days
Title
Knee injury and Osteoarthritis Outcome Score
Description
Changes in KOOS score from first visit to final visit. The min value is 0 and the max value 100, were the min value represents no problem and max value represents extreme problems
Time Frame
180 days
Title
NSAID consumption
Description
Incidence of NSAID consumption from first visit to final visit
Time Frame
180 days
Other Pre-specified Outcome Measures:
Title
AE, SAE, ADE, SADE, DD incidence.
Description
To investigate the overall safety and tolerability of the two medical devices during the by overall study period.
Time Frame
180 days
Title
Physician Global Tolerability
Description
Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 40 and 80 years
Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III);
Ambulant without assistance;
Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
VAS knee pain ≥40 at screening and 30 days before;
At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
Signed Informed consent
Exclusion Criteria:
Unstable knee;
Varus or valgus ≥ 15 degrees;
Active malignancy;
Knee trauma or lose body parts 1 year before screening;
Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
Intra-articular HA or corticosteroid injection within 6 months before screening;
Arthroscopic or knee open surgery within 12 months before screening;
Body Mass Index (BMI) ≥ 40 kg/m2;
Active infection around the injection site;
Use of anticoagulants or history of thrombocytopenia;
Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
Known sensitivity to HA or DVS;
Pregnancy, breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Puenea
Organizational Affiliation
Fizio Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fizio Center
City
Timişoara
State/Province
Timis
ZIP/Postal Code
300211
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
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