Osteoarthritis, Knee
Conditions
Keywords
IA PAAG HBISA Hydrous biopolymer with silver ions Argiform
Brief summary
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.
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 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).
Interventions
None listed
Sponsors
Research Centre BIOFORM
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Total WOMAC Score (WOMAC-T) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the WOMAC Pain Score (WOMAC-A) | 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) | 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. |
| Change in the WOMAC Stiffness (WOMAC-B) Score | 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) | 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. |
| Change in the WOMAC Physical Function (WOMAC-C) Score | 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) | 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. |
| Change in the 100-mm VAS Pain Score | 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) | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 30 |
| Group NOLTREX™ 1 Course Group NOLTREX™ 1 course comprised 17 patients who received one NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019). | 17 |
| 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. | 10 |
| Total | 57 |
Baseline characteristics
| Characteristic | Total | Group NOLTREX™ 2 Courses | Group NOLTREX™ 1 Course | Placebo Group |
|---|---|---|---|---|
| Age, Continuous Age | 63.23 Age in years STANDARD_DEVIATION 6.92 | 63.73 Age in years STANDARD_DEVIATION 6.55 | 61.71 Age in years STANDARD_DEVIATION 7.35 | 64.30 Age in years STANDARD_DEVIATION 7.57 |
| Body Mass Index (BMI) | 28.66 kg/m^2 STANDARD_DEVIATION 3.07 | 29.06 kg/m^2 STANDARD_DEVIATION 3.26 | 27.04 kg/m^2 STANDARD_DEVIATION 1.91 | 30.25 kg/m^2 STANDARD_DEVIATION 3.09 |
| Body weight | 79.68 kilogram STANDARD_DEVIATION 10.85 | 80.18 kilogram STANDARD_DEVIATION 11.87 | 75.29 kilogram STANDARD_DEVIATION 5.61 | 85.65 kilogram STANDARD_DEVIATION 12.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 30 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Female | 10 Participants | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 47 Participants | 27 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 17 | 0 / 10 |
| other Total, other adverse events | 0 / 30 | 0 / 17 | 0 / 10 |
| serious Total, serious adverse events | 0 / 30 | 0 / 17 | 0 / 10 |
Outcome results
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group NOLTREX™ 2 Courses | Change in the Total WOMAC Score (WOMAC-T) | visit 1 study 1 | 1137.13 score on a scale | Standard Deviation 375.18 |
| Group NOLTREX™ 2 Courses | Change in the Total WOMAC Score (WOMAC-T) | OLE visit 0 | 445.33 score on a scale | Standard Deviation 252.01 |
| Group NOLTREX™ 2 Courses | Change in the Total WOMAC Score (WOMAC-T) | OLE visit 5 | 319.07 score on a scale | Standard Deviation 203.24 |
| Group NOLTREX™ 2 Courses | Change in the Total WOMAC Score (WOMAC-T) | EOF | 423.00 score on a scale | Standard Deviation 250.02 |
| Group NOLTREX™ 1 Course | Change in the Total WOMAC Score (WOMAC-T) | OLE visit 5 | 78.94 score on a scale | Standard Deviation 20.77 |
| Group NOLTREX™ 1 Course | Change in the Total WOMAC Score (WOMAC-T) | EOF | 50.82 score on a scale | Standard Deviation 31.78 |
| Group NOLTREX™ 1 Course | Change in the Total WOMAC Score (WOMAC-T) | OLE visit 0 | 260.29 score on a scale | Standard Deviation 150.02 |
| Group NOLTREX™ 1 Course | Change in the Total WOMAC Score (WOMAC-T) | visit 1 study 1 | 767.47 score on a scale | Standard Deviation 227.42 |
| Placebo Group | Change in the Total WOMAC Score (WOMAC-T) | EOF | 722.10 score on a scale | Standard Deviation 246.71 |
| Placebo Group | Change in the Total WOMAC Score (WOMAC-T) | visit 1 study 1 | 1271.60 score on a scale | Standard Deviation 247.29 |
| Placebo Group | Change in the Total WOMAC Score (WOMAC-T) | OLE visit 0 | 616.00 score on a scale | Standard Deviation 230.18 |
Comparison: No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.p-value: 0ANCOVA
Comparison: Post-hoc pairwise comparisons were performed using Tukey test.p-value: 095% CI: [178.91, 527.45]Tukey's HSD
Comparison: Post-hoc pairwise comparisons were performed using Tukey test.p-value: 095% CI: [-480.37, -104.01]Tukey's HSD
Comparison: Post-hoc pairwise comparisons were performed using Tukey test.p-value: 095% CI: [-876.07, -414.67]Tukey's HSD
Comparison: The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.p-value: 0ANCOVA
Comparison: Post-hoc pairwise comparisons were performed using Tukey test.p-value: 095% CI: [-480.37, -104.01]Tukey's HSD
Comparison: Post-hoc pairwise comparisons were performed using Tukey test.p-value: 095% CI: [-876.07, -414.67]Tukey's HSD
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group NOLTREX™ 2 Courses | Change in the 100-mm VAS Pain Score | visit 1 study 1 | 61.23 score on a scale | Standard Deviation 10.9 |
| Group NOLTREX™ 2 Courses | Change in the 100-mm VAS Pain Score | OLE visit 0 | 20.90 score on a scale | Standard Deviation 9.82 |
| Group NOLTREX™ 2 Courses | Change in the 100-mm VAS Pain Score | OLE visit 5 | 20.80 score on a scale | Standard Deviation 12 |
| Group NOLTREX™ 2 Courses | Change in the 100-mm VAS Pain Score | EOF | 28.43 score on a scale | Standard Deviation 12.46 |
| Group NOLTREX™ 1 Course | Change in the 100-mm VAS Pain Score | OLE visit 0 | 9.47 score on a scale | Standard Deviation 5.51 |
| Group NOLTREX™ 1 Course | Change in the 100-mm VAS Pain Score | EOF | 9.88 score on a scale | Standard Deviation 13.41 |
| Group NOLTREX™ 1 Course | Change in the 100-mm VAS Pain Score | OLE visit 5 | 4.88 score on a scale | Standard Deviation 3.14 |
| Group NOLTREX™ 1 Course | Change in the 100-mm VAS Pain Score | visit 1 study 1 | 64.35 score on a scale | Standard Deviation 10.86 |
| Placebo Group | Change in the 100-mm VAS Pain Score | visit 1 study 1 | 59.50 score on a scale | Standard Deviation 10.09 |
| Placebo Group | Change in the 100-mm VAS Pain Score | EOF | 42.70 score on a scale | Standard Deviation 13.53 |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group NOLTREX™ 2 Courses | Change in the WOMAC Pain Score (WOMAC-A) | visit 1 study 1 | 233.20 score on a scale | Standard Deviation 77.68 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Pain Score (WOMAC-A) | OLE visit 0 | 80.93 score on a scale | Standard Deviation 50.74 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Pain Score (WOMAC-A) | OLE visit 5 | 59.70 score on a scale | Standard Deviation 43.68 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Pain Score (WOMAC-A) | EOF | 80.27 score on a scale | Standard Deviation 51.92 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Pain Score (WOMAC-A) | OLE visit 5 | 3.12 score on a scale | Standard Deviation 2.87 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Pain Score (WOMAC-A) | EOF | 3.29 score on a scale | Standard Deviation 3.74 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Pain Score (WOMAC-A) | OLE visit 0 | 44.24 score on a scale | Standard Deviation 28.77 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Pain Score (WOMAC-A) | visit 1 study 1 | 158.18 score on a scale | Standard Deviation 63.77 |
| Placebo Group | Change in the WOMAC Pain Score (WOMAC-A) | EOF | 131.10 score on a scale | Standard Deviation 64.15 |
| Placebo Group | Change in the WOMAC Pain Score (WOMAC-A) | visit 1 study 1 | 239.10 score on a scale | Standard Deviation 68.76 |
| Placebo Group | Change in the WOMAC Pain Score (WOMAC-A) | OLE visit 0 | 103.90 score on a scale | Standard Deviation 48.31 |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group NOLTREX™ 2 Courses | Change in the WOMAC Physical Function (WOMAC-C) Score | visit 1 study 1 | 807.77 score on a scale | Standard Deviation 295.02 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Physical Function (WOMAC-C) Score | OLE visit 0 | 331.17 score on a scale | Standard Deviation 186.01 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Physical Function (WOMAC-C) Score | OLE visit 5 | 236.83 score on a scale | Standard Deviation 146.82 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Physical Function (WOMAC-C) Score | EOF | 311.10 score on a scale | Standard Deviation 175.33 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Physical Function (WOMAC-C) Score | OLE visit 5 | 85.59 score on a scale | Standard Deviation 24.11 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Physical Function (WOMAC-C) Score | EOF | 40.29 score on a scale | Standard Deviation 23.94 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Physical Function (WOMAC-C) Score | OLE visit 0 | 189.76 score on a scale | Standard Deviation 109.22 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Physical Function (WOMAC-C) Score | visit 1 study 1 | 539.35 score on a scale | Standard Deviation 170.29 |
| Placebo Group | Change in the WOMAC Physical Function (WOMAC-C) Score | EOF | 528.80 score on a scale | Standard Deviation 168.15 |
| Placebo Group | Change in the WOMAC Physical Function (WOMAC-C) Score | visit 1 study 1 | 931.50 score on a scale | Standard Deviation 182.82 |
| Placebo Group | Change in the WOMAC Physical Function (WOMAC-C) Score | OLE visit 0 | 455.20 score on a scale | Standard Deviation 158.93 |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group NOLTREX™ 2 Courses | Change in the WOMAC Stiffness (WOMAC-B) Score | visit 1 study 1 | 96.17 score on a scale | Standard Deviation 38.32 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Stiffness (WOMAC-B) Score | OLE visit 0 | 33.23 score on a scale | Standard Deviation 26.38 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Stiffness (WOMAC-B) Score | OLE visit 5 | 22.53 score on a scale | Standard Deviation 20.7 |
| Group NOLTREX™ 2 Courses | Change in the WOMAC Stiffness (WOMAC-B) Score | EOF | 31.63 score on a scale | Standard Deviation 28.2 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Stiffness (WOMAC-B) Score | OLE visit 5 | 21.24 score on a scale | Standard Deviation 6.71 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Stiffness (WOMAC-B) Score | EOF | 7.24 score on a scale | Standard Deviation 5.58 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Stiffness (WOMAC-B) Score | OLE visit 0 | 26.29 score on a scale | Standard Deviation 18.11 |
| Group NOLTREX™ 1 Course | Change in the WOMAC Stiffness (WOMAC-B) Score | visit 1 study 1 | 69.94 score on a scale | Standard Deviation 26.93 |
| Placebo Group | Change in the WOMAC Stiffness (WOMAC-B) Score | EOF | 62.20 score on a scale | Standard Deviation 28.18 |
| Placebo Group | Change in the WOMAC Stiffness (WOMAC-B) Score | visit 1 study 1 | 101.00 score on a scale | Standard Deviation 24.51 |
| Placebo Group | Change in the WOMAC Stiffness (WOMAC-B) Score | OLE visit 0 | 56.90 score on a scale | Standard Deviation 32.63 |