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The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™ | Other | Sixty-five (65) patients were included in the study and divided into three groups based on the number of NOLTREX™ courses received:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ | Device | If clinically indicated patients received a repeat course of NOLTREX™ (one or two weekly intra-articular injections of 4.0 NOLTREX™ at the investigator's discretion depending on the stage of OA and clinical response to treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Total WOMAC Score (WOMAC-T) | Mean change in WOMAC-T from baseline (visit 0 [screening] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
| 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 AND visit 0 [screening] of OLE) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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:
Exclusion Criteria:
Pregnancy and breastfeeding;
History of trauma or surgery on the target knee joint;
Instability of the target knee joint;
Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
Seronegative spondyloarthritis and reactive arthritis;
Increased rheumatoid factor;
Increased uric acid > 360 µmol/l;
Intra-articular injection into the target knee joint:
Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
Effusion in the target joint;
The presence of inflammation or infection in the target joint, synovitis;
The need for continuous use of glucocorticoids in any dosage form;
Use of paracetamol within 48 hours prior to Visit 0;
A positive blood test result for one or more of the following infections: HIV, hepatitis B and C, syphilis;
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;
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]);
Clinical manifest coxarthrosis;
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 ;
Participation in any other clinical trial except that IA/PAAG-SI/OA/2019 within 90 days prior to enrollment in the OLE.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir V Popov, DSc | Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways" | Moscow | Russia | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 1/2 of the OLE (IA/PAAG-SI/OA/2020) study. |
| FG001 | Group B | Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 3/4 of OLE. |
| FG002 | Group C | Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Demographic and baseline characteristics were described by group in the safety population (SP). The safety population was the same as the ITT population and included all randomised patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study. |
| BG001 | Group B |
| Units | Counts |
|---|---|
| Participants |
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| 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 WOMAC-T from baseline (visit 0 [screening] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | The intent-to-treat (ITT) population (all subjects randomized in the parent study) | Posted | Mean | Standard Deviation | score on a scale | baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
6 months from visit 0 to visit 5.
Adverse events are counted in the safety population. The safety population completely overlapped with the ITT population.
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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 A | Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 1/2 of the OLE (IA/PAAG-SI/OA/2020) study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suspected coronavirus disease 2019 (COVID-19) | Infections and infestations | MedDRA | Systematic Assessment | Suspected coronavirus disease 2019 (COVID-19) was considered as apparently not related to the assigned treatment. |
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| 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 | Oct 30, 2020 | Nov 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2021 | Nov 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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| baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
| Change in the WOMAC Stiffness (WOMAC-B) Score | Mean change in WOMAC-B from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23) |
| Change in the WOMAC Physical Function (WOMAC-C) Score | Mean change in WOMAC-C from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23) |
| Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS) | Mean change in the VAS pain score from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study to visit 2 (week 1), visit 3 (week 11) and visit 5 (week 23). The 0 to 100 mm visual analogue scale (VAS) was used for measuring pain intensity. VAS ratings between 0 and 4 mm were interpreted as no pain, 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. The pain VAS was self-completed by the patients. | baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
| Patient's Assessment of the Treatment Efficacy | Patient satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23). | visits 3 (week 13) and 5 (week 25) |
| Investigator's Assessment of the Treatment Efficacy | Investigator satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23). | visits 3 (week 13) and 5 (week 25) |
| Total Number of Paracetamol Tablets Taken | A patient diary was used to capture data about the number of paracetamol 500 mg tablets taken. | visits 3 (week 13) and 5 (week 25) |
| Total Number of NSAID Tablets Taken | A patient diary was used to capture data about the number of NSAID tablets taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take protocol-permitted NSAID at certain doses. | visits 3 (week 11) and 5 (week 23) |
| The JSN in the Target Knee | Joint space narrowing (JSN) was scored by comparison of subsequent radiographs taken over time. An increase in the radiographic knee JSN is associated with osteoarthritis progression. | baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE |
| "Clinical Diagnostic Center "Ultramed", LLC |
| Omsk |
| Russia |
| Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg | Saint Petersburg | Russia |
| State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3" | Yaroslavl | Russia |
Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE.
| BG002 | Group C | Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Obesity | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Group A | Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study. |
| OG001 | Group B | Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE. |
| OG002 | Group C | Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study |
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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 AND visit 0 [screening] of OLE) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. | The intent-to-treat (ITT) population (all subjects randomized in the parent study). | Posted | Mean | Standard Deviation | score on a scale | baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
|
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| Secondary | Change in the WOMAC Stiffness (WOMAC-B) Score | Mean change in WOMAC-B from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | The intent-to-treat (ITT) population (all subjects randomized in the parent study). | Posted | Mean | Standard Deviation | score on a scale | baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23) |
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| Secondary | Change in the WOMAC Physical Function (WOMAC-C) Score | Mean change in WOMAC-C from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study) to visits 3 (week 11) and 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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, and 0-1700 for Physical Function. Higher scores represent worse stiffness and functional limitations. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score. | The intent-to-treat (ITT) population (all subjects randomized in the parent study) | Posted | Mean | Standard Deviation | score on a scale | baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23) |
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| Secondary | Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS) | Mean change in the VAS pain score from baseline (visit 0 [screening] of the OLE and visit 1 [week 1] of the parent study to visit 2 (week 1), visit 3 (week 11) and visit 5 (week 23). The 0 to 100 mm visual analogue scale (VAS) was used for measuring pain intensity. VAS ratings between 0 and 4 mm were interpreted as no pain, 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. The pain VAS was self-completed by the patients. | The intent-to-treat (ITT) population (all subjects randomized in the parent study) | Posted | Mean | Standard Deviation | score on a scale | baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23) |
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| Secondary | Patient's Assessment of the Treatment Efficacy | Patient satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23). | The intent-to-treat (ITT) population (all subjects randomized in the parent study) | Posted | Count of Participants | Participants | visits 3 (week 13) and 5 (week 25) |
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| Secondary | Investigator's Assessment of the Treatment Efficacy | Investigator satisfaction with treatment was measured by a 6-point Likert scale (evident aggravation, aggravation, without changes, weak improvement, improvement, significant improvement) at the study visits 3 (week 11) and 5 (week 23). | The intent-to-treat (ITT) population (all subjects randomized in the parent study). | Posted | Count of Participants | Participants | visits 3 (week 13) and 5 (week 25) |
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| Secondary | Total Number of Paracetamol Tablets Taken | A patient diary was used to capture data about the number of paracetamol 500 mg tablets taken. | The intent-to-treat (ITT) population (all subjects randomized in the parent study). The mean number of tablets was calculated taking into account only patients who had received paracetamol. | Posted | Number | paracetamol tablets | visits 3 (week 13) and 5 (week 25) |
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| Secondary | Total Number of NSAID Tablets Taken | A patient diary was used to capture data about the number of NSAID tablets taken. In case of paracetamol ineffectiveness and pain persistence patient was allowed to take protocol-permitted NSAID at certain doses. | The intent-to-treat (ITT) population (all subjects randomized in the parent study) | Posted | Number | NSAID tablets | visits 3 (week 11) and 5 (week 23) |
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| Secondary | The JSN in the Target Knee | Joint space narrowing (JSN) was scored by comparison of subsequent radiographs taken over time. An increase in the radiographic knee JSN is associated with osteoarthritis progression. | The intent-to-treat (ITT) population (all subjects randomized in the parent study). | Posted | Mean | Standard Deviation | millimeters | baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE |
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| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Group B | Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the parent (IA/PAAG-SI/OA/2019) study and the second one at Visits 3/4 of OLE. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Group C | Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study. | 0 | 17 | 0 | 17 | 0 | 17 |
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| OLE visit 3 |
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| OLE visit 5 |
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| OLE visit 3 |
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| OLE visit 5 |
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| OLE visit 3 |
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| OLE visit 5 |
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| visit 3 |
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| visit 5 |
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BASELINE (OLE visit 0) To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution. |
| Kruskal-Wallis |
| 0.002 |
The threshold for statistical significance was p <0.05. |
| Superiority |
| visit 3 To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution. | ANOVA | 0.007 | The threshold for statistical significance was p <0.05. | Superiority |
| visit 5 To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution. | Kruskal-Wallis | <0.001 | The threshold for statistical significance was p <0.05. | Superiority |
| without changes |
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| weak improvement |
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| improvement |
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| significant improvement |
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| Visit 5 |
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visit 5
Fisher's exact test was used to determine whether there is a significant difference between 3 groups.
| Fisher Exact |
| <0.001 |
| Superiority |
| without changes |
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| weak improvement |
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| improvement |
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| significant improvement |
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| Visit 5 |
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visit 5
Fisher's exact test was used to determine whether there was a significant difference between 3 groups.
| Fisher Exact |
| <0.001 |
The threshold for statistical significance was p <0.05. |
| Superiority |
| Title | Measurements |
|---|---|
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| Title | Measurements |
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