Back to results

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

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

We'll reach out to this number within 24 hrs