Knee OsteoarthritisPILHACNCT06097988
Study on Knee Osteoarthritis
A study testing ABIO3419 in people with Knee Osteoarthritis, run by Symatese at 2 sites in Latvia.
Trial summary
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ABIO3419
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesLatvia
- Study dates
- 2 Feb 2024to 16 Sep 2024
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- Male and female subjects, aged 35 to 85 years (inclusive).
- Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for osteoarthritis of the knee, and meeting the following conditions:
- Kellgren-Lawrence Grade 2 to 3 severity osteoarthritis of the knee confirmed by an extension face X-rays shot, supported by flexion face X-rays shot (optional) obtained within 6 months from the screening visit.
- Subjects suffering from osteoarthritis symptoms of the target knee for at least 6 months prior to the screening visit.
- Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm Visual Analogic Scale at the baseline visit (Visit 2).
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- Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
- Subject who is able to comply with the study requirements, at the Investigator's appreciation.
- Subject being affiliated to a health social security system
Who cannot join
- Pregnant and breastfeeding women
- Subject with bilateral osteoarthritis of the knees is excluded if one of the following point is present on the non-targeted knee has:
- a visual analog scale score greater than 30mm (> 30mm),
- a Kellgren-Lawrence score is greater than 2 (>2)
- a dedicated antalgic consumption.
- Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
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- Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
- Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
- Subject with a past history of severe streptococcal disease or an active streptococcus infection according to the investigator opinion.
- Subject with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- Subject having received chemotherapy agents, immunosuppressive medications within the past 3 months.
- Subject with bleeding disorders or subject received medication (anti-platelet agents and anticoagulant) that will likely increase the risk of bleeding within the past 24 hours before injections.
- Subjects having received:
- Intra-articular knee corticosteroids within 60 days prior to the baseline visit.
- Chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates or matrix metalloproteinase inhibitors within 30 days prior to the baseline visit.
- Viscosupplementation of the target knee within 6 months prior to the baseline visit.
- Any kind of antalgic and Non-steroidal anti-inflammatory drugs in the 24 hours prior to the baseline visit (V2) and before each visit.
- Subjects with a Kellgren-Lawrence grade 4 femora-patellar osteoarthritis or subjects with a femora-patellar osteoarthritis Kellgren-Lawrence grade higher than the femora-tibial one.
- Subjects with coxarthrosis.
- Subjects having had any previous surgery in the target knee within 6 months prior to the screening visit, or any planned surgery in the target knee throughout the duration of the investigation.
- Subjects who have had arthroplasty at the target knee at any time.
- Subjects having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit.
- Subjects that are candidate for knee replacement within next 6 months.
- Subjects with body mass index > 35 kg/m2.
- Subjects with large intra-articular effusion of the target knee, venous or lymphatic stasis, inflammatory flare-up with various symptoms, local inflammation.
- Subjects with history of septic osteoarthritis of any joint
- Subjects with significant pain outside the target knee, including significant hip or back pain and with fibromyalgia.
- Subjects with clinically significant valgus/varus deformities, ligamentous laxity, or meniscal instability as assessed by the Investigator.
- Subjects with other musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee (e.g. Paget's disease of bone).
- Subjects with a current malignancy or having treatment for a malignancy, except non-melanoma skin cancer.
- Subjects with drug or alcohol abuse
- Subject who is deprived of their freedom by administrative or legal decision.
- Subject living in a social or sanitary establishment.
- Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
- Other condition preventing the subject to participate the study in the Investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective, Multicenter Clinical Investigation Evaluating the Safety of ABIO3419 in Treating Knee Osteoarthritis: Pilot Study
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways.
The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms.
Read more
Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms.
Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.
Read the detailed description
The study is a pilot, prospective, multicenter, clinical trial that aims to evaluate the safety and efficacy of ABIO3419 for the treatment of knee osteoarthrosis.
- Conditions
- Knee Osteoarthritis
- Being tested
- ABIO3419
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABIO3419Device
Intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| ABIO3419 | Experimental | Patients will be included consecutively to receive ABIO3419 by intra-articular injection Receives: Device: ABIO3419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse device effects related to ABIO34199 treatment [tolerability] at 3 months
Assessment by the investigators of the occurrence of adverse device effects related to ABIO3419 from the first injection up to the 3-month follow-up
Measured: Month 3 after the last injection
Secondary outcomes (9)
Incidence of Treatment-Emergent Adverse Events [Safety]
Collection of Adverse Event assessed and recorded by investigators.
Measured: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
Evaluation of the pain of the treated knee when walking on a flat ground.
Assessment by the patient itself of the pain compared to baseline (before initial injection) using a 0-100mm Visual Analogue Scale (0 corresponds to no pain and 100 corresponds to the highest pain that can be felt).
Measured: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Device related complication rates
Assessment of the proportion of patient with at least one adverse device effect related to ABIO3419 at each time visits
Measured: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
General health status of the treated knee
Assessment by the patient itself of the target-knee functional status using the Knee injury and Osteoarthritis Outcome Score (KOOS).
The KOOS holds 42 items in 5 separately scored subscales: Pain (nine items); Symptoms (seven items); Function in daily living (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
A 5-grade Likert scale is used for all items scored from 0 (No Problems) to 4 (Extreme Problems).
Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Measured: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Concomitant analgesic consumption
Assessment by the patient of the average weekly consumption (number and dosage) of paracetamol and pain killer drugs using a daily diary.
Measured: 1 week before the first injection, 1 week and 2 weeks after the first injection then 2 weeks, 1 month and 3 months after the last injection.
Implant card readability
Assessment of the patient of the reading and understanding of the ABIO3419 implant card using a questionnaire on which the text present on the implant card must be identified and reported on the questionnaire.
Measured: Day 0 (after first injection)
Investigator Global satisfaction
Assessement by the investigator of the handling of the ABIO3419 device with a Usability questionnaire after the third injection with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Measured: Week 2 after first injection
Investigator Global satisfaction
Assessement by the investigator of the overall satisfaction with a satisfaction questionnaire at 6 months with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Measured: Month 6
Patient Global satisfaction
Assessement by the patient of the overall satisfaction with a satisfaction questionnaire at 6 months with four response possibilities for each item: Very satisfied / Satisfied / Neutral / Not satisfied.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start2 Feb 2024
- Primary completion19 Jun 2024
- Study completion16 Sep 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symatese
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristaps KNOHENFELDS, Principal investigator, Veselibas Centrs ZINKalvis KRASTINS, Principal investigator, Private Office Centrs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097988
- Sponsor's protocol ID
- CLIN2301
- Acronym
- PILHAC
- Status last verified
- Nov 2024
- First submitted
- 13 Oct 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Investigation Evaluating the Safety of ABIO3419 in Treating Knee Osteoarthritis: Pilot Study
- ClinicalTrials.gov ID
- NCT06097988
- Acronym / sponsor ID
- PILHAC / CLIN2301
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SymateseIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways.
The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms.
Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms.
Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.
Detailed description
The study is a pilot, prospective, multicenter, clinical trial that aims to evaluate the safety and efficacy of ABIO3419 for the treatment of knee osteoarthrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| ABIO3419 | Experimental | Device: ABIO3419Patients will be included consecutively to receive ABIO3419 by intra-articular injection |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
- Male and female subjects, aged 35 to 85 years (inclusive).
- Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for osteoarthritis of the knee, and meeting the following conditions:
- Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm Visual Analogic Scale at the baseline visit (Visit 2).
- Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
Key exclusion criteria (35 listed)
- Pregnant and breastfeeding women
- Subject with bilateral osteoarthritis of the knees is excluded if one of the following point is present on the non-targeted knee has:
- Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
- Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
- Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
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 |
|---|---|---|
| ABIO3419Intra-articular injection | Device | ABIO3419 |
Primary outcome
Incidence of adverse device effects related to ABIO34199 treatment [tolerability] at 3 months
Time frame: Month 3 after the last injection
Assessment by the investigators of the occurrence of adverse device effects related to ABIO3419 from the first injection up to the 3-month follow-up
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
Evaluation of the pain of the treated knee when walking on a flat ground.
Time frame: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Device related complication rates
Time frame: Immediately after first injection, before and immediately after the injections at 1 week and 2 weeks, then at 2 weeks, 1 month, 3 months and 6 months after the last injection
General health status of the treated knee
Time frame: Baseline (before initial injection), 1 week and 2 weeks after the first injection (before 2nd and 3rd injections) then 2 weeks, 1 month and 3 months after the last injection.
Concomitant analgesic consumption
Time frame: 1 week before the first injection, 1 week and 2 weeks after the first injection then 2 weeks, 1 month and 3 months after the last injection.
Implant card readability
Time frame: Day 0 (after first injection)
Investigator Global satisfaction
Time frame: Week 2 after first injection
Investigator Global satisfaction
Time frame: Month 6
Patient Global satisfaction
Time frame: month 6
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 19 Nov 2024.
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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.
Kristaps KNOHENFELDS principal investigator
Veselibas Centrs ZIN
Kalvis KRASTINS principal investigator
Private Office Centrs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABIO3419 in people with Knee Osteoarthritis, run by Symatese at 2 sites in Latvia.
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 9 inclusion and 35 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Latvia. 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?
Incidence of adverse device effects related to ABIO34199 treatment [tolerability] at 3 months (time frame: Month 3 after the last injection). 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 19 Nov 2024.