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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
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).
Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"
Moscow, Russia
"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
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.
Time frame: baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)
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.
Time frame: 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
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline (visit 1 of the parent study IA/PAAG-SI/OA/2019), visit 5 (week 23) of OLE