Knee OsteoarthritisNCT04693104
Intra-articular PVA Hydrogel in Knee Osteoarthritis
A study testing PVA Hydrogel and Synvisk-One® in people with Knee Osteoarthritis, run by Rottapharm Biotech at 1 site in Poland.
Trial summary
This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PVA Hydrogel and Synvisk-One®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2019to 20 May 2020
- 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
- Signed and dated informed consent obtained before undergoing any clinical-investigation-related procedure.
- Male or female aged between 40 and 80 years.
- Documented diagnosis of primary OA of the knee, based on the clinical and radiological American College of Rheumatology (ACR) criteria for knee OA:
- Knee pain,
- X-ray osteophytes,
- at least one of the following: (a) age >50 years; (b) morning stiffness <30 minutes in duration; (c) crepitus on active motion.
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- Grade II-III according to the Kellgren and Lawrence classification (X-ray evidence at enrolment or within the previous 12 months).
- Knee OA symptoms for at least six months.
- Failure to respond (i.e. did not respond sufficiently) to analgesics and/or regular NSAIDs, or proven intolerance to regular use of NSAIDs or to weak opioids analgesics.
- Presence of pain in the target knee, with a value ≥4 and ≤9 on the NRS, providing that pain in the contralateral knee I less than 3 (see also Exclusion Criteria n. 3).
- Ability and willingness to communicate, participate, and comply with the requirements and scheduled procedures of the clinical investigation.
Who cannot join
- Medical history and Concomitant Diseases related criteria
- Presence of isolated or predominantly symptomatic patellofemoral OA of the knee (i.e. pain when climbing stairs or forcing the patient to extend his leg when sitting on a low sit).
- Presence of secondary osteoarthritis and/or other rheumatic diseases. In particular, history or presence of the following diseases should be excluded: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, articular fracture, ochronosis, acromegaly, haemocromatosis, Wilson's disease, primary osteochondromatosis.
- Contralateral (i.e. non-target) knee pain >3 on the NRS
- Any knee OA treatment for both knees (other than the clinical investigation viscosupplementation of the target knee) anticipated within the next 6 months.
- Presence of pain (any severity) in the ipsilateral and/or contralateral hip.
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- Presence of disease of the spine or other lower extremity joints of sufficient severity to affect the clinical investigation assessments.
- Anterior cruciate ligament repair, reconstruction or injury in the target knee within the previous 3 years.
- Cartilage repair/surgery in the target knee within the previous 3 years.
- Any surgery in the lower limbs within the previous 12 months
- Any planned surgery of the lower limbs during the clinical investigation period.
- Significant articular deformities of the lower limbs, i.e. major dysplasia and congenital abnormalities.
- Presence of varus or valgus knee deformity ≥ 8°.
- History or presence of osteonecrosis in the lower limbs.
- Presence of any significant injury of the ipsilateral limb within the previous 6 months.
- Presence of joint effusion and/or infection at the target knee.
- Presence of local skin abnormalities (e.g. infection or disease) at the target knee.
- History or presence of knee joint infection secondary to previous intra-articular injections, or increased predisposition to infections.
- History or high risk of venous thromboembolism and/or venous or lymphatic stasis of the limb of the target knee.
- History of allergy or known hypersensitivity to hyaluronic acid, to any of the components of the products under clinical investigation, or to paracetamol.
- History of hypersensitivity to avian proteins.
- Morbidly obese patients (BMI≥35).
- Severe concomitant disease at any organ or apparatus (including acute or chronic infectious diseases) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the clinical investigation and/or malignancy (with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or in situ uterine cervical cancer) active within the previous 12 months.
- History of drug, alcohol, or other substance abuse, or other factors limiting the ability to cooperate during the clinical investigation.
- Any other clinically relevant disease and condition that, in the opinion of the principal investigators, may jeopardize the clinical investigation conduct according to the CIP or performance or safety assessments or may compromise the patients' safety or may place the patient at an undue risk by participating in the clinical investigation.
- Previous or concomitant treatments
- Patients requiring systemic analgesics (including opiates)/NSAIDs for the target knee, or for indications other than OA pain at the target knee but likely to use these medications for more than 5 consecutive days, or for more than 10 non-consecutive days in one month, or unable to stop them during the 2 days preceding a clinic visit.
- Patients requiring topical analgesics/NSAIDs for the target knee.
- Patient requiring intra-articular corticosteroids into any joint or periarticular structure in the lower limb, or systemic corticosteroids (oral or injected for any indication).
- Patients who underwent tidal lavage of the knee joint(s) during the three months prior to randomization.
- Viscosupplementation in the lower limbs within the previous 12 months.
- Patients on SYSADOAs or a dietary supplement containing compounds considered specific for OA (e.g. glucosamine, chondroitin sulphate, diacerein) if the dosage has not been stable within the previous 3 months.
- Patients on anticoagulant treatment other than direct oral anticoagulants (DOACS).
- Non-pharmacological therapy for the lower extremities, unless stable for more than one month (and not to be substantially altered during the clinical investigation). Physical therapy is allowed.
- Patients using assistive devices other than a cane (walking stick) or knee brace.
- Concomitant participation in any clinical study/investigation or treatment with any investigational drugs/treatments/devices within the previous 3 months or 5 of half-lives (whichever is longer).
- Contraindication to use of hyaluronic acid.
- Contraindication to use of paracetamol. (c) Other
- For women of childbearing potential, not surgically sterile or postmenopausal:
- Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding;
- Failure to agree to practice a highly effective method of contraception for 3 months after the IA injection.
- For sexually active men with a female partner of childbearing potential: failure to use a reliable method of birth control for 3 months after the IA injection.
- Randomization Criteria:
- Pain value in the target knee ≥4 and ≤9 on the NRS.
- Absence of joint effusion in the target knee.
- Absence of local skin abnormalities (e.g. infection or disease) at the target knee.
- No use of analgesics/NSAIDs during the 2 days preceding the Randomization Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of PVA Hydrogel in Comparison With Synvisc-One®, in Patients With Knee Osteoarthritis
This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and best performing hyaluronic acid based products, in patients with symptomatic knee osteoarthitis (OA).
Read the detailed description
To compare the effects of a single intra-articular injection of a novel polyvinyl alcohol preparation (PVA Hydrogel) and hylan G-F20 (Synvisc-One®) in patients with symptomatic knee OA.
Patients with knee OA (ACR clinical and radiological criteria) symptoms for ≥6 months, insufficient/failed response to analgesics, K\&L stage II-III (x-Rays within past 12 months), a knee pain score of 4-9 (0-10 NRS) in the target knee and <3 in the contralateral knee, will be enrolled in a randomised, controlled, double-blind, parallel group 26-week clinical investigation to receive a single intra-articular injection of PVA Hydrogel or Synvisc-One®. Safety (both at the injection site (primary end-point) and overall) and efficacy (change in pain in the target knee (0-10 NRS), WOMAC Osteoarthritis Index (total and subscales) and Patient's Global Assessment of knee OA (0-10 NRS)) will be evaluated.
After signing an informed consent, patients will be screened at least 7 days before randomisation, when they will received a single intra-articular injection of either PVA Hydrogel or Synvisc-One® (1:1 allocation ratio) and will be then seen for follow-up 1, 2 and 4 days (this latter just in case of AE occurrence at the target knee) and 2, 4, 8, 12, 18 and 26 weeks after IA injection.
- Conditions
- Knee Osteoarthritis
- Being tested
- PVA Hydrogel, Synvisk-One®
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVA HydrogelDevice
PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.
Synvisk-One®Device
Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.
| Study group | Role | What they receive |
|---|---|---|
| PVA Hydrogel | Experimental | PVA Hydrogel (Rottapharm Biotech, Monza): 2 mL prefilled syringe for intra-articular injection Receives: Device: PVA Hydrogel |
| Synvisc-One® | Active comparator | Synvisc-One® (Genzyme Corporation, Ridegield, New Jersey, USA): 6 mL prefilled syringe for intra-articular injection Receives: Device: Synvisk-One® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events at the injection site (target knee)
patient reported symptom and/or investigator detected clinical sign
Measured: 6 months
Adverse Device Events
AEs considered as related to the device and/or to the IA procedure.
Measured: 6 months
Secondary outcomes (10)
Device Deficiencies
malfunctions, use errors and inadequate labelling occurred before, during or after the use of the devices
Measured: 6 months
Adverse Events
any AE irrespective of target knee involvement
Measured: 6 months
Physical examination
a complete physical examination will be carried out at all scheduled clinic visits and/or at any unscheduled/early termination visit in case of premature discontinuation. Clinically significant findings of the physical examination at screening will be documented as concomitant diseases. New findings or worsening of a finding at all visits following the screening visit will recorded as adverse events.
Measured: 6 months
Blood pressure
Systolic and diastolic blood pressure (mmHg)
Measured: 6 months
Pulse rate
Radial pulse rate (beats/minute)
Measured: 6 months
Body temperature
Body temperature will be assessed via a mouth thermometer (degrees Celsius (°C)
Measured: 6 months
Knee pain
0-10 NRS ("0=no pain" to "10=the worst possible pain") during past 48 hours
Measured: 6 months
WOMAC Index
tri-dimensional, disease-specific, self-administered, health status measure, to assess pain, stiffness and physical function in patients with knee OA, NRS format, version 3.1, 48 hours recall period
Measured: 6 months
Patient's Global Assessment of knee OA
overall judgment of efficacy ("Considering all the ways your knee osteoarthritis affects you, how would you rate the severity of your condition over the last week?" according to a 0-10 NRS scale, anchored at 0 = "I am feeling very well" and 10 = "I am feeling as bad as possible"
Measured: 6 months
Rescue medication use
Number of paracetamol tablets taken each day
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Oct 2019
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomaz Blicharski, Study director, Lubelskie Centrum Diagnostyczne, Swidnik, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693104
- Sponsor's protocol ID
- PVA-001
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PVA Hydrogel in Comparison With Synvisc-One®, in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04693104
- Acronym / sponsor ID
- PVA-001
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Rottapharm BiotechIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre, prospective, randomized, double-blind, active-controlled, parallel group clinical investigation is aimed to assess the safety and the clinical performance over 6 months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and best performing hyaluronic acid based products, in patients with symptomatic knee osteoarthitis (OA).
Detailed description
To compare the effects of a single intra-articular injection of a novel polyvinyl alcohol preparation (PVA Hydrogel) and hylan G-F20 (Synvisc-One®) in patients with symptomatic knee OA.
Patients with knee OA (ACR clinical and radiological criteria) symptoms for ≥6 months, insufficient/failed response to analgesics, K\&L stage II-III (x-Rays within past 12 months), a knee pain score of 4-9 (0-10 NRS) in the target knee and <3 in the contralateral knee, will be enrolled in a randomised, controlled, double-blind, parallel group 26-week clinical investigation to receive a single intra-articular injection of PVA Hydrogel or Synvisc-One®. Safety (both at the injection site (primary end-point) and overall) and efficacy (change in pain in the target knee (0-10 NRS), WOMAC Osteoarthritis Index (total and subscales) and Patient's Global Assessment of knee OA (0-10 NRS)) will be evaluated.
After signing an informed consent, patients will be screened at least 7 days before randomisation, when they will received a single intra-articular injection of either PVA Hydrogel or Synvisc-One® (1:1 allocation ratio) and will be then seen for follow-up 1, 2 and 4 days (this latter just in case of AE occurrence at the target knee) and 2, 4, 8, 12, 18 and 26 weeks after IA injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVA Hydrogel | Experimental | Device: PVA HydrogelPVA Hydrogel (Rottapharm Biotech, Monza): 2 mL prefilled syringe for intra-articular injection |
| Synvisc-One® | Active comparator | Device: Synvisk-One®Synvisc-One® (Genzyme Corporation, Ridegield, New Jersey, USA): 6 mL prefilled syringe for intra-articular injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated informed consent obtained before undergoing any clinical-investigation-related procedure.
- Male or female aged between 40 and 80 years.
- Documented diagnosis of primary OA of the knee, based on the clinical and radiological American College of Rheumatology (ACR) criteria for knee OA:
- Grade II-III according to the Kellgren and Lawrence classification (X-ray evidence at enrolment or within the previous 12 months).
- Knee OA symptoms for at least six months.
Key exclusion criteria (47 listed)
- Medical history and Concomitant Diseases related criteria
- Presence of isolated or predominantly symptomatic patellofemoral OA of the knee (i.e. pain when climbing stairs or forcing the patient to extend his leg when sitting on a low sit).
- Presence of secondary osteoarthritis and/or other rheumatic diseases. In particular, history or presence of the following diseases should be excluded: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, articular fracture, ochronosis, acromegaly, haemocromatosis, Wilson's disease, primary osteochondromatosis.
- Contralateral (i.e. non-target) knee pain >3 on the NRS
- Any knee OA treatment for both knees (other than the clinical investigation viscosupplementation of the target knee) anticipated within the next 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVA HydrogelPVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections. | Device | PVA Hydrogel |
| Synvisk-One®Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections. | Device | Synvisc-One® |
Primary outcome
Adverse Events at the injection site (target knee)
Time frame: 6 months
patient reported symptom and/or investigator detected clinical sign
Adverse Device Events
Time frame: 6 months
AEs considered as related to the device and/or to the IA procedure.
10 secondary outcomes
Device Deficiencies
Time frame: 6 months
Adverse Events
Time frame: 6 months
Physical examination
Time frame: 6 months
Blood pressure
Time frame: 6 months
Pulse rate
Time frame: 6 months
Body temperature
Time frame: 6 months
Knee pain
Time frame: 6 months
WOMAC Index
Time frame: 6 months
Patient's Global Assessment of knee OA
Time frame: 6 months
Rescue medication use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomaz Blicharski study director
Lubelskie Centrum Diagnostyczne, Swidnik, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVA Hydrogel and Synvisk-One® in people with Knee Osteoarthritis, run by Rottapharm Biotech at 1 site in Poland.
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 11 inclusion and 47 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Adverse Events at the injection site (target knee) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.