Back to resultsA Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hylan G-F 20
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion criteria :
- The participants had a diagnosis of OA of the Target Knee confirmed by recent X-Ray (mild to moderate joint space narrowing and/or osteophytes predominant in the tibiofemoral compartment)
- WOMAC A1 baseline 100 mm Visual Analog Score (VAS) between 40-80 mm (moderate or severe walking pain) in the Target knee
Participants with bilateral disease included in the study with the below strict conditions:
- Only one knee included in the efficacy assessment and considered the Target Knee (The worst knee by the WOMAC A1 pain scale should be selected). The selected knee must meet the inclusion and exclusion criteria
- The non-target knee might also be treated with Synvisc® and did not need to meet the Kellgren-Lawrence (KL) grade knee specific inclusion criteria described above. The other criteria applied, and included in safety assessment
- Pre-menopausal female participants had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females had been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year
Exclusion criteria:
- Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability
- Concomitant inflammatory or any other disease/condition which might affect joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc)
- History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint
- History of surgery in the target knee (if done < 6 months)
- Planned surgery on any lower extremity joint
- Presence of clinically significant venous or lymphatic stasis in the leg(s)
- Clinically apparent tense effusion or inflammation at the target knee
- Skin disease or infection in the area of the injection site
- Any musculoskeletal condition that would impede measurement of efficacy at the target knee
- Pregnant or lactating women
- Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection
- Treatment with any Hyaluronic Acid (HA) or derivatives in the previous 6 months.
- Treatment with Intra-Articular (IA) steroid in the previous 3 months
- Any contra-indication to IA injection e.g., anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
- Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Synvisc
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
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)
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
Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
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.
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
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.
Patient Global Assessment (PTGA) Score
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586338
Brief Title
A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Official Title
A Multicenter, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Synvisc® (Hylan G-F 20) in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
237 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synvisc
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc®
Intervention Description
Intra-articular injection (pre-filled glass syringe)
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
Description
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.
Time Frame
Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
Title
Overview of Adverse Events (AE)
Description
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.
Time Frame
Up to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
Description
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.
Time Frame
Baseline, Week 8 and Week 12 (missing data imputed by LOCF)
Title
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
Description
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.
Time Frame
Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Title
Patient Global Assessment (PTGA) Score
Description
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.
Time Frame
Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Title
Clinical Observer Global Assessment (COGA) Score
Description
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.
Time Frame
Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Title
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Description
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.
Time Frame
Baseline up to Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
The participants had a diagnosis of OA of the Target Knee confirmed by recent X-Ray (mild to moderate joint space narrowing and/or osteophytes predominant in the tibiofemoral compartment)
WOMAC A1 baseline 100 mm Visual Analog Score (VAS) between 40-80 mm (moderate or severe walking pain) in the Target knee
Participants with bilateral disease included in the study with the below strict conditions:
Only one knee included in the efficacy assessment and considered the Target Knee (The worst knee by the WOMAC A1 pain scale should be selected). The selected knee must meet the inclusion and exclusion criteria
The non-target knee might also be treated with Synvisc® and did not need to meet the Kellgren-Lawrence (KL) grade knee specific inclusion criteria described above. The other criteria applied, and included in safety assessment
Pre-menopausal female participants had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females had been surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year
Exclusion criteria:
Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability
Concomitant inflammatory or any other disease/condition which might affect joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc)
History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint
History of surgery in the target knee (if done < 6 months)
Planned surgery on any lower extremity joint
Presence of clinically significant venous or lymphatic stasis in the leg(s)
Clinically apparent tense effusion or inflammation at the target knee
Skin disease or infection in the area of the injection site
Any musculoskeletal condition that would impede measurement of efficacy at the target knee
Pregnant or lactating women
Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection
Treatment with any Hyaluronic Acid (HA) or derivatives in the previous 6 months.
Treatment with Intra-Articular (IA) steroid in the previous 3 months
Any contra-indication to IA injection e.g., anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)
Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Shangai
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
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