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Osteo Arthritis KneeNCT04358120

A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Chondroitin Sulfate in Knee Osteoarthritis

A study testing Hyaluronic Acid Combined With Chondroitin Sulfate in people with Osteo Arthritis Knee, run by Fidia Farmaceutici s.p.a. at 5 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicentre, prospective, sponsor initiated clinical investigation that aims to evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in symptomatic patients with OA of the knee. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Hyaluronic Acid Combined With Chondroitin Sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
5 sitesCzechia
Study dates
28 Nov 2017to 18 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At Screening
  • Male or female between the ages of 40 and 80
  • Body Mass Index (BMI) ≤ 30;
  • Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40. The most painful knee is considered the target knee;
  • OA of the Knee radiologically and clinically confirmed responding to criteria of American College of Rheumatology (ACR): pain of the knee and crepitus on active motion or morning stiffness less than 30 minutes or age >50 years
  • Symptomatic knee pain for more than 6 months;
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  • Radiological Kellgren and Lawrence grade II or III confirmed by an X-ray not older than 12 months;
  • Willing to discontinue any systemic analgesic/NSAID therapy, opioids, systemic corticosteroids, skeletal muscle relaxants, and any other medication that would interfere with the study assessments, except for the rescue medication, with no intention to resume them during the clinical investigation (see Appendix 5 for wash out period);
  • Patient able to comply with the instructions of the clinical investigation and to maintain a Rescue Medication Diary during the study;
  • Having signed the study informed consent.
  • at Baseline
  • Patient does not have chondromatosis or villonodular synovitis of the knee evaluated by Ultrasound;
  • Patient has complied with the requirements for rescue medication (no more than 6 tablets or 3 grams of paracetamol per day up to 4 days per week and paracetamol discontinued 24 hours before first IA injection);
  • Mean knee pain score at rest over the last 24 hours evaluated on VAS (0 - 100) ≥ 40 (with a washout period for Paracetamol of 24 hours);
  • Patient has discontinued prior to Baseline the use of all prohibited medications in accordance with the washout period defined in Appendix 5;
  • Patient continues to meet all Screening inclusion/exclusion criteria at the Baseline visit.

Who cannot join

  • Related to the OA pathology
  • Recent trauma (< 1 month) of the target knee responsible for the symptomatic knee pain;
  • Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, haemophilia, hemochromatosis;
  • Inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, gout and infectious arthritis, acute calcium pyrophosphate arthritis);
  • Pathologies interfering with the evaluation of OA. Related to treatments
  • Corticosteroids injection in the target knee in the last 3 months before first intra-articular (IA) injection;
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  • Hyaluronan injection in the target knee in the last 6 months before first IA injection;
  • Arthroscopy and surgery in the target knee in the last 3 months before first IA injection;
  • Oral corticosteroid therapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first IA injection;
  • OA treatments based on curcuma extract in the last 3 months before first IA injection;
  • Change in the dosage of symptomatic slow-acting drugs (SYSADOA) e.g., chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before first IA injection;
  • Contraindications to 4% GAG: hypersensitivity to the product components;
  • Infections or skin diseases in the area of the injection site;
  • Change in the dosage of ongoing non-pharmacologic therapy for the lower extremities (including physical therapy) initiated in the month before first injection;
  • Anticoagulant (coumarinic compound) and heparin. Related to associated diseases
  • Severe diseases (e.g., liver or renal failure, lung/heart disease, tumour, HIV);
  • Severe alteration of mobility interfering with the functional evaluation;
  • High risk of haemorrhage;
  • Patient with known allergy to paracetamol;
  • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee.
  • Related to study subjects
  • Participation to a therapeutic clinical trial in the last 3 months before first injection;
  • Pregnancy, breastfeeding, planned conception and premenopausal women without contraception, tubal ligation or hysterectomy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Czechia5 sites

  • Revmacentrum MUDr. Mostera,

    Brno

  • Rheumatology, Polyclinic Lesná

    Brno

  • Institute of rheumatology

    Prague

  • University Hospital Motol, Department of Rheumatology of Children and Adults

    Prague

  • Medical Plus, s.r.o

    Uherské Hradiště

Other trials in Czechia

About this study

Official title: A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of a New Viscosupplement Based on Hyaluronic Acid Combined With Chondroitin Sulfate in Patients With Knee Osteoarthritis

This is a multicentre, prospective, sponsor initiated clinical investigation that aims to evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in symptomatic patients with OA of the knee.

Being tested
Hyaluronic Acid Combined With Chondroitin Sulfate
Keywords
Hyaluronic Acid, Chondroitin sulfate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic Acid Combined With Chondroitin SulfateDevice

    Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits.

    Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments.

    Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection

Study groups in NCT04358120
Study groupRoleWhat they receive
Hyaluronic Acid Combined With Chondroitin SulfateOtherThe treatment consists of 3 intra articular injections of Hyaluronic Acid With Chondroitin Sulfate administered one per week for 3 consecutive weeks: the 1st at Visit 1 (Week 0), the 2nd at Visit 2 (Week 1) and the 3rd at Visit 3 (Week 2)
Receives: Device: Hyaluronic Acid Combined With Chondroitin Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain score measured by Visual Analogue Scale (VAS)

    Change in pain perception from baseline in patient with knee osteoarthritis after three intra-articular 2% Chondroitin Sulfate + 2% hyaluronic Acid injections assessed by Visual Analogue Scale (VAS) (From 0 to 100) at weeks 6, 14 and 26

    Measured: at week 6, 14 and 26

Secondary outcomes (10)

  1. Change in Patient's Global Assessment

    Change from baseline up to 26 weeks after first treatment in Patient's Global Assessment of knee functional disability, assessed by VAS (0-100)

    Measured: at weeks 6, 14 and 26

  2. Change from baseline in knee pain and function up to 26 weeks

    Change from baseline provided by the intra-articular 2% Chondroitin Sulfate + 2% Hyaluronic Acid injections measured by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (0-100 mm) for knee at weeks 6, 14 and 26

    Measured: at weeks 6, 14 and 26

  3. Change from baseline up to 26 weeks after first treatment on knee functional disability on Clinical Observer Global Assessment (COGA)

    Change from baseline up to 26 weeks after first treatment in COGA of knee functional disability, assessed by VAS (0-100)

    Measured: at weeks 6, 14 and 26

  4. Number of patients Responder to treatment

    Number of patients with clinical response to treatment using the OMERACT-OARSI set of criteria: high improvement in pain or function ≥ 50% or improvement in at least 2 of the 3 of the following criteria: high improvement in pain or function ≥ 50% or improvement in at least 2 of the 3 following:

    • pain ≥ 20% and absolute change ≥10,
    • function ≥20% and absolute change ≥10,
    • PGA ≥ 20% and absolute change ≥10.

    Measured: Weeks 6, 14 and 26

  5. Change from baseline in Synovitis at 6 weeks

    Change in Synovitis at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA.

    A global score for synovitis corresponds to the maximum score for synovitis obtained at the suprapatellar or parapatellar recesses.

    Synovitis (grades 0-3): Grade 0 = no synovitis, Grade 1= minimal distension, Grade 2= moderate distension or enlargement, Grade 3= severe distension or enlargement of the recess

    Measured: at week 6

  6. Change from baseline in Synovial hypertrophy at 6 weeks

    Change in Synovial hypertrophy at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA.

    Synovial hypertrophy (0-1) where 0= absence, 1= presence

    Measured: at week 6

  7. Change from baseline in knee Effusion at 6 weeks

    Change in Effusion at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA.

    Effusion (0-1) 0= absence, 1= presence

    Measured: at week 6

  8. Change from baseline in popliteal cyst at 6 weeks

    Change in Popliteal cyst at week 6 vs week 0 assessed by ultrasound scored according to the scoring systems proposed by OMERACT US on knee OA.

    Popliteal cyst (0-1) 0= absence, 1= presence

    Measured: at week 6

  9. Change in Synovial Power Doppler signal at week 6

    Changein Synovial Power Doppler signal at week 6 vs week 0 assessed by ultrasound.

    Synovial Power Doppler signal (0-1) and (0-3) Grade 0 = no intra-articular colour signal Grade 1 = up to three signal colour signals or two single and one confluent colour signals representing only low flow

    Measured: at week 6

  10. Safety of the treatment. Number of patient with treatment related adverse events

    Safety evaluation by tracking the number of patient withdrawals and their adverse events correlated to treatment at each visit

    Measured: through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start28 Nov 2017
  3. Primary completion18 Sep 2018
  4. Study completion18 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358120
Sponsor's protocol ID
RR82-17-01
Status last verified
Mar 2020
First submitted
2 Mar 2020
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hyaluronic Acid Combined With Chondroitin Sulfate in people with Osteo Arthritis Knee, run by Fidia Farmaceutici s.p.a. at 5 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain score measured by Visual Analogue Scale (VAS) (time frame: at week 6, 14 and 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.

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