Assessment of Efficacy of a Single Intra-articular Injection of HYALUBRIX 60 in Knee Osteoarthritis

NCT06113783 | Recruiting

• 1 other identifier: EQB7-20-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain reduction from baseline

  Pain intensity will be measured by means of the WOMAC Pain VAS scale (Scale A) (1-100 mm). The mean change in WOMAC Pain VAS score in the target knee from baseline to 2 months will be the primary efficacy endpoint.

  2 months

Secondary Outcomes (8)

• Pain reduction from baseline

  1,2, 6 and 12 months

• Reduction of Stiffness, physical function and overall WOMAC in the target knee from baseline

  1,2, 6 and 12 months

• Treatment response from baseline

  1, 2, 6 and 12 months

• EQ-5D-5L score changes from baseline

  2, 6, 12 months

• Improvement of physical function from baseline

  2, 6, 12 months

Study Arms (2)

Group 1- ACTIVE

EXPERIMENTAL

Intra-articular injection at baseline of HYALUBRIX 60® plus PEP 3 times a week at home for the 12 months of observation;

Device: HYALUBRIX 60

Group 2-CONTROL

NO INTERVENTION

Physical Exercise Program alone 3 times a week at home for the 12 months of observation.

Interventions

HYALUBRIX 60 DEVICE

1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight.

Also known as: HYALONE

Group 1- ACTIVE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures;
• Male or female subjects aged ≥18 years and ≤70 years with active life-style;
• BMI ≤40 kg/m2;
• Patients affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee, and meeting the following conditions:
• Kellgren-Lawrence Grade 2 to 3 severity OA of the target knee with presence of osteophytes determined from X-rays of the knee obtained within 6 months from the screening visit; i.e. in the tibio-femoral compartment of the target knee with at least 1 osteophyte and measurable joint space, as diagnosed by standard X-rays (anterior- posterior view \[weight bearing extension or semi-flexion\] and lateral). In the case that a patient has not a valid X-ray within 6 months prior to screening, the exam is to be performed during the screening period;
• Patients suffering from OA symptoms of the target knee for at least 3 months prior to the screening visit; Note: patients with bilateral OA of the knee will be allowed as long as they can differentiate pain in the target knee, do not need to use analgesics for treatment of their contralateral knee, and do not expect to receive treatment of the contralateral knee during the investigation. In the case that both knees are eligible for the investigation based on pain intensity, the knee with the greater pain VAS score on the WOMAC pain VAS A1 subscale (walking on a flat surface) will be selected as the target knee;
• Pain ≥50 mm on the WOMAC pain VAS A1 subscale (walking on a flat surface) in the target knee;
• Patients having discontinued use of all systemic analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) therapy for at least 7 days (24 hours for paracetamol) prior to the screening visit and agree not to resume them during the investigation. Note: paracetamol will be provided to patients as rescue medication.
• If female of child-bearing potential, must have a negative urine pregnancy test at the screening visit and use a reliable form of contraception for more than 1 month prior to Screening and throughout the investigation. Note: to be considered females of non-child- bearing potential, females must be surgically sterile or postmenopausal as documented in medical history for at least 1 year. Highly effective birth control methods include: combined hormonal contraception (containing estrogens and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.\*
• Note: According to 4.1 paragraph "Birth control methods which may be considered as highly effective" of the Clinical Trial Facilitation Group (CTFG)/Recommendations related to contraception and pregnancy testing in clinical trials.

You may not qualify if:

• Radiographic assessment confirming abnormal patellofemoral tracking or articulation or abnormal/excessive patellar subluxation in lateral view;
• Major injury to or disorder of the contralateral knee or other weight-bearing joint that would interfere with the study assessments;
• Secondary OA due to a prior or concomitant condition (e.g., septic arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia, or congenital abnormality, hemochromatosis, etc.);
• Patients who have had arthroplasty at the target knee at any time;
• Surgery in the target knee within the previous 12 months prior to Screening or any planned surgery throughout the duration of the investigation;
• Surgery in the contralateral knee or other weight-bearing joint within the previous 12 months that would interfere with the study assessments;
• Patients that are candidate for knee replacement within the next 12 months;
• Patients having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit, or patients in which such procedures are planned during the study;
• Patients with total joint replacement implants, unicondylar implants or patellofemoral replacement implants in the study joint;
• Ligament reconstruction of the target knee in the previous 3 years;
• Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis;
• Patients with clinically relevant intra-articular effusion of the target knee;
• Episode of gout or calcium pyrophosphate (pseudogout) diseases within 6 months prior to Screening;
• Patients having received:
• Corticosteroids by systemic administration within 30 days prior to the screening visit.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy

Roma, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Valter Santilli

  UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Giordan

CONTACT

+390498232512; ngriordan@fidiapharma.it

Ornella Sortino

CONTACT

+39049832582; osortino@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: post-market, monocentre, randomized, controlled clinical investigation

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 2, 2023
• Study Start: June 16, 2022
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)