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1-year follow-up of a randomized controlled trial with open-label extension to assess the long-term efficacy and safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis.
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 this 1-year follow-up was to evaluate the long-term safety and efficacy of IA Polyacrylamide hydrogel with silver ions in patients with Kellgren-Lawrence grade 3 and 4 knee osteoarthritis who had received one or two treatment courses in the IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020 studies.
Follow-up data were collected in telephone interviewing (using questionnaire) in April-July 2022, 12 months after the completion of OLE (IA/PAAG-SI/OA/2020).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group NOLTREX 2 courses | Group NOLTREX 2 courses consisted of 30 patients who had received 2 NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020) | ||
| Group NOLTREX 1 course | Group NOLTREX 1 course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019) | ||
| Placebo group | Placebo group consisted of 10 patients who had received placebo in the parent study IA/PAAG-SI/OA/2019 and had not taken part in OLE. Of 72 patients approached, only 10 agreed to participate and completed the survey. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Total WOMAC Score (WOMAC-T) | Mean change in the total WOMAC score from visit 1 of the parent study (baseline), visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF) up to 24 months post Baseline Visit 1 Study 1. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status. | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the WOMAC Pain Score (WOMAC-A) | Mean change in WOMAC-A from baseline (visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain. |
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Inclusion criteria:
The study included patients with KL grade 2-3 knee osteoarthritis who had completed study IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020.
Exclusion criteria:
Declining participation in the survey Lost to follow-up
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The study included 57 patients divided into 3 subgroups based on treatment received:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey M Noskov, Prof. PhD | State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg | Saint Petersburg | Russia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 2 NOLTREX™ Courses | Group 2 NOLTREX™ courses consisted of 30 patients who had received 2 NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). |
| FG001 | Group 1 NOLTREX™ Course | Group 1 NOLTREX™ course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019). |
| FG002 | Placebo Group | Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic and baseline characteristics were described by group in the whole study population which included participants of the studies IA/PAAG-SI/OA/2020 and IA/PAAG-SI/OA/2019.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group NOLTREX™ 2 Courses | Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). |
| BG001 | Group NOLTREX™ 1 Course |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Total WOMAC Score (WOMAC-T) | Mean change in the total WOMAC score from visit 1 of the parent study (baseline), visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF) up to 24 months post Baseline Visit 1 Study 1. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status. | Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group. | Posted | Mean | Standard Deviation | score on a scale | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
From visit 5 of OLE (study IA/PAAG-SI/OA/2020) to the end of follow-up study (up to 12 months) for NOLTREX Groups, and from Baseline Visit 1 Study 1 to the end of follow-up study (up to 24 months) for the Placebo Group
Current study did not specifically collect adverse event data. Safety assessment was based on absolute and relative contraindications for repeated intra-articular treatment and physician-reported data, including information on analgesic intake.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group NOLTREX™ 2 Courses | Group NOLTREX™ 2 courses consisted of 30 patients who had received two NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). |
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Findings in the placebo group should be interpreted with caution because of the limited number of participants. Besides it should be noted that concomitant use of paracetamol was allowed in the RCT.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Melentyeva Commercial Director | RCBIOFORM | 84952237095 | md@bioform.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2021 | Sep 4, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2021 | Sep 4, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
| Change in the WOMAC Stiffness (WOMAC-B) Score | Mean change in WOMAC-B from baseline (visit 1 [week 1] of the parent study IA/PAAG-SI/OA/2019, visits 0 [screening] and 5 [week 23] of OLE IA/PAAG-SI/OA/2020) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness. Higher scores represent worse stiffness. | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
| Change in the WOMAC Physical Function (WOMAC-C) Score | Mean change in WOMAC-C from the baseline visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-1700 for Physical Function. Higher scores represent worse functional limitations. The higher the score, the poorer the function. | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
| Change in the 100-mm VAS Pain Score | Mean change in the VAS pain score from the baseline visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF). The visual analog scale (VAS) is one of the most commonly used measures of pain intensity. The pain VAS was self-completed by the respondent. The respondent was asked to place the slider perpendicular to the VAS line at the point that represents their pain intensity. The score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
| State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3" |
| Yaroslavl |
| Russia |
Group NOLTREX™ 1 course comprised 17 patients who received one NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019).
| BG002 | Placebo Group | Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019; concomitant use of paracetamol (oral NSAIDs) was allowed) and had not taken part in OLE. |
| BG003 | Total | Total of all reporting groups |
| Age in years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body weight | Mean | Standard Deviation | kilogram |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Change in the WOMAC Pain Score (WOMAC-A) | Mean change in WOMAC-A from baseline (visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain. | Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group. | Posted | Mean | Standard Deviation | score on a scale | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
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| Secondary | Change in the WOMAC Stiffness (WOMAC-B) Score | Mean change in WOMAC-B from baseline (visit 1 [week 1] of the parent study IA/PAAG-SI/OA/2019, visits 0 [screening] and 5 [week 23] of OLE IA/PAAG-SI/OA/2020) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness. Higher scores represent worse stiffness. | Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group. | Posted | Mean | Standard Deviation | score on a scale | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
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| Secondary | Change in the WOMAC Physical Function (WOMAC-C) Score | Mean change in WOMAC-C from the baseline visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-1700 for Physical Function. Higher scores represent worse functional limitations. The higher the score, the poorer the function. | Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group. | Posted | Mean | Standard Deviation | score on a scale | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
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| Secondary | Change in the 100-mm VAS Pain Score | Mean change in the VAS pain score from the baseline visit 1 [week 1] of the parent study, visits 0 [screening] and 5 [week 23] of OLE to the end of 12-month follow-up (EOF). The visual analog scale (VAS) is one of the most commonly used measures of pain intensity. The pain VAS was self-completed by the respondent. The respondent was asked to place the slider perpendicular to the VAS line at the point that represents their pain intensity. The score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. | Analysis population included participants of the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020). In the study IA/PAAG-SI/OA/2019 the amount of paracetamol intake in placebo group was significantly larger compared to the NOLTREX™ group. | Posted | Mean | Standard Deviation | score on a scale | From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1) |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Group NOLTREX™ 1 Course | Group NOLTREX™ 1 course comprised 17 patients who received a NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019). | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Placebo Group | Placebo group consisted of 10 patients who had received placebo in the parent study (IA/PAAG-SI/OA/2019) and had not taken part in OLE. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012216 |
| Rheumatic Diseases |
| OLE visit 0 |
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| OLE visit 5 |
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| EOF |
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| OLE visit 0 |
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| OLE visit 5 |
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| EOF |
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| OLE visit 0 |
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| OLE visit 5 |
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| EOF |
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| OLE visit 0 |
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| OLE visit 5 |
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| EOF |
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