A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)

Phase 4

Completed

Conditions: Osteoarthritis

Interventions: Drug: Hylan G-F 20

Registration Number: NCT01586338

Lead Sponsor: Sanofi

Brief Summary: Primary Objective:

* To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score

* To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs)

Secondary Objectives:

* To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12

* To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26

* To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26

* To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26

* To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26

Detailed Description: Duration of study period for each participants was 26-28 weeks.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 237

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Synvisc	Hylan G-F 20	Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26	Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])	WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Overview of Adverse Events (AE)	Up to Week 26	An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study drug until the end of study period). Category "AE" included participant with both serious and non-serious AE.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.
Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12	Baseline, Week 8 and Week 12 (missing data imputed by LOCF)	WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Patient Global Assessment (PTGA) Score	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.
Clinical Observer Global Assessment (COGA) Score	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26	Baseline up to Week 26	Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.