Clinical trial NCT06429319: Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
Official title: An Open-label Multicenter Postmarketing Extension Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: intra-articular
polyacrylamide hydrogel
PAAG
HBISA (Hydrous biopolymer with silver ions "Argiform")
NOLTREX
Lead sponsor: Research Centre BIOFORM
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was an open-label extension (OLE) of the IA/PAAG-SI/OA/2019 study designed to evaluate the long-term safety and efficacy of MD NOLTREX™ in patients with knee osteoarthritis (OA). The study was expected to enroll 72 patients who had completed the parent study. Actually 67 patients rolled over into the OLE, 2 of them were classified as screen failures and 65 were enrolled into the trial.
Primary purpose: TREATMENT

Brief summary: The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.

Detailed description: HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.

The aim of the 6-month OLE was to evaluate the long-term safety and efficacy of one and two courses of IA Polyacrylamide hydrogel with silver ions in patients with knee osteoarthritis who had received at least one IA injection of NOLTREX™ and completed the visit 5 in the IA/PAAG-SI/OA/2019 study.

In OLE patients who had received a course of treatment (one or two weekly intra-articular injections of 4.0 NOLTREX™ depending on the stage of OA and the clinical response to treatment) in the parent study might receive a single repeat course of NOLTREX™ at the visits 1/2 or 3/4 when clinically indicated. The WOMAC was the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Men and women over 50 years of age;
* Provision of signed informed consent form;
* Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age \>50 years, stiffness \<30 min, crepitus, bony tenderness, bony enlargement and no palpable warmth);
* OA grades 2 and 3 on the Kellgren-Lawrence scale with the predominant involvement of the medial tibiofemoral region of the knee joint;
* Patients from the NOLTREX™ group of the parent study (IA/PAAG-SI/OA/2019) who completed all (5) study visits

Exclusion Criteria:

1. Pregnancy and breastfeeding;
2. History of trauma or surgery on the target knee joint;
3. Instability of the target knee joint;
4. Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
5. History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
6. Seronegative spondyloarthritis and reactive arthritis;
7. Increased rheumatoid factor;
8. Increased uric acid \> 360 µmol/l;
9. Intra-articular injection into the target knee joint:

   * hyaluronates - within 12 months prior to patient enrollment in the study;
   * other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
   * glucocorticoids - within 1 month before enrollment in the study;
   * NSAIDs - intra-articular injection at any time in the history.
10. Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
11. Effusion in the target joint;
12. The presence of inflammation or infection in the target joint, synovitis;
13. The need for continuous use of glucocorticoids in any dosage form;
14. Use of paracetamol within 48 hours prior to Visit 0;
15. A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
16. Severe liver disease, defined as an increase in one of the following: ALT, AST, alkaline phosphatase, total bilirubin, GGT more than 3 times the upper limit of normal;
17. Kidney disease with a glomerular filtration rate as assessed by the Cockcraft-Gault formula less than 60 mL/min/1.73 m2 (stages III-V chronic kidney disease \[CKD\]);
18. Clinical manifest coxarthrosis;
19. Severe decompensated chronic or acute diseases and other conditions or other causes that, in the investigator's opinion, may prevent the patient from participating in the study or affect the study results ;
20. Participation in any other clinical trial except that IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the OLE.

Primary outcomes:
measure: Change in the Total WOMAC Score (WOMAC-T)
timeFrame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
Secondary outcomes:
measure: Change in the WOMAC Pain Score (WOMAC-A)
timeFrame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
measure: Change in the WOMAC Stiffness (WOMAC-B) Score
timeFrame: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
measure: Change in the WOMAC Physical Function (WOMAC-C) Score
timeFrame: baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)
measure: Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)
timeFrame: baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
measure: Patient's Assessment of the Treatment Efficacy
timeFrame: visits 3 (week 13) and 5 (week 25)
measure: Investigator's Assessment of the Treatment Efficacy
timeFrame: visits 3 (week 13) and 5 (week 25)
measure: Total Number of Paracetamol Tablets Taken
timeFrame: visits 3 (week 13) and 5 (week 25)
measure: Total Number of NSAID Tablets Taken
timeFrame: visits 3 (week 11) and 5 (week 23)
measure: The JSN in the Target Knee
timeFrame: baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
city: Omsk
country: Russian Federation
facility: "Clinical Diagnostic Center "Ultramed", LLC
city: Saint Petersburg
country: Russian Federation
facility: Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
city: Yaroslavl
country: Russian Federation
facility: State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Study officials:
affiliation: Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
name: Vladimir V Popov, DSc
role: PRINCIPAL_INVESTIGATOR
References: