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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1131-0507 | Other Identifier | UTN |
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Primary Objective:
-To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score, in comparison to an IA placebo injection over 26 weeks, in Chinese participants with symptomatic Osteoarthritis (OA) of the knee.
Secondary Objectives:
The duration of the study was 29 weeks at maximum. The screening and wash-out period lasted for up to 14 days, depending on the half-life of the medications followed by an 8-day baseline period including the treatment day. Overall, there were up to 21 days between signing informed consent (at screening visit) and the randomization (Day 1). Treatment was administered on Day 1, and follow-up period was 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. |
|
| Hylan G-F 20 | Experimental | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylan G-F 20 (GZ402662/SAR402662) | Device | Pharmaceutical form: Solution for injection Route of administration: Intra articular |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks | The WOMAC Numerical Rating Scale (NRS) version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with Osteoarthritis (OA) of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. | From Baseline up to Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks | The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. For 7-day average WOMAC A1, the baseline value was defined as the average of the WOMAC A1 scores recorded 7 days prior to the first investigational medicinal product (IMP) administration (WOMAC A1 score recorded on Day 1 included). The 7-day average WOMAC A1 was set as missing if 3 or more of the 7 WOMAC A1 scores were missing. |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 1560001 | Beijing | 100044 | China | |||
| Investigational Site Number 1560005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33964907 | Derived | Ke Y, Jiang W, Xu Y, Chen Y, Zhang Q, Xue Q, Lin J, Ngai W, Nian G, Fazeli MS, Xie Y, Zhu Z. Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis : C-SOUND study, a 26-week multicenter double-blind randomized placebo-controlled trial in China. BMC Musculoskelet Disord. 2021 May 8;22(1):428. doi: 10.1186/s12891-021-04252-2. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 440 participants were enrolled and randomized in the study. Assignment to arms was done centrally using an interactive voice response system/interactive web response system (IVRS/IWRS) in 1:1 ratio (Placebo: Hylan G-F 20).
The study was conducted at 21 sites in China from 21 August 2017 to 28 January 2019. A total of 524 participants were screened, of which, 84 participants were screen failures. Screen failures were mainly due to inclusion criteria not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single intra-articular (IA) injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. |
| FG001 | Hylan G-F 20 | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 17, 2017 | Jan 19, 2020 |
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| Placebo | Drug | Pharmaceutical form: Solution for injection Route of administration: Intra articular |
|
| From Baseline up to Week 26 |
| Change From Baseline in WOMAC A Score Over 26 Weeks | The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A (5 items: measure of pain while walking, using stairs, at night while in bed, sitting or lying, and standing); each item was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. Total WOMAC A score was the sum of 5 item scores and ranges from 0 (none) to 50 (extreme); where lower score represented no pain and higher score represented extreme pain. | From Baseline up to Week 26 |
| Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks | PTGA (self-assessment of target knee OA condition) was measured using an 11-point NRS ranging from 0 (best possible) to 10 (worst possible), where lower score represented best possible condition and higher score represented worst possible condition. | From Baseline up to Week 26 |
| Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks | COGA was used by the physicians to perform a global assessment of the participant's target knee OA condition. The response was captured using the 11-point NRS pain intensity rating scale ranging from 0 (best possible) to 10 (worst possible) at the specified time points, where lower score represented best possible condition and higher score represented worst possible condition. | From Baseline up to Week 26 |
| Percentage of Positive WOMAC A1 Responder Over 26 Weeks | WOMAC A1 responder were defined as >=2-point improvement from baseline in the WOMAC A1 NRS. The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. | Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the on-treatment period (time from the injection of IMP up to Week 26 follow-up visit). | From Baseline up to Week 26 |
| Beijing |
| 100050 |
| China |
| Investigational Site Number 1560020 | Beijing | 100191 | China |
| Investigational Site Number 1560009 | Beijing | 100730 | China |
| Investigational Site Number 1560012 | Changchun | 130021 | China |
| Investigational Site Number 1560013 | Changsha | 410008 | China |
| Investigational Site Number 1560023 | Chengdu | 610041 | China |
| Investigational Site Number 1560016 | Guangzhou | 510080 | China |
| Investigational Site Number 1560011 | Hohhot | 010017 | China |
| Investigational Site Number 1560017 | Kunming | 650032 | China |
| Investigational Site Number 1560019 | Nanjing | 210009 | China |
| Investigational Site Number 1560021 | Nanjing | 210029 | China |
| Investigational Site Number 1560007 | Qingdao | 266003 | China |
| Investigational Site Number 1560002 | Shanghai | 200011 | China |
| Investigational Site Number 1560003 | Shanghai | 200032 | China |
| Investigational Site Number 1560022 | Shanghai | 200072 | China |
| Investigational Site Number 1560018 | Taiyuan | 030001 | China |
| Investigational Site Number 1560010 | Tianjin | 300052 | China |
| Investigational Site Number 1560015 | Tianjin | 300192 | China |
| Investigational Site Number 1560006 | Wuhan | 430033 | China |
| Investigational Site Number 1560008 | Wuxi | 214023 | China |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on randomized population which consisted of all participants with a treatment kit number allocated and recorded in IVRS/IWRS database, and regardless of whether the treatment kit was used or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. |
| BG001 | Hylan G-F 20 | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | 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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| 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 From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks | The WOMAC Numerical Rating Scale (NRS) version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with Osteoarthritis (OA) of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. | Analysis was performed on modified Intent-To-Treat (mITT) population which included all randomized and treated participants. Participants were analyzed in the treatment group to which they were randomized. | Posted | Least Squares Mean | Standard Error | score on a scale | From Baseline up to Week 26 |
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| Secondary | Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks | The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. For 7-day average WOMAC A1, the baseline value was defined as the average of the WOMAC A1 scores recorded 7 days prior to the first investigational medicinal product (IMP) administration (WOMAC A1 score recorded on Day 1 included). The 7-day average WOMAC A1 was set as missing if 3 or more of the 7 WOMAC A1 scores were missing. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | score on a scale | From Baseline up to Week 26 |
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| Secondary | Change From Baseline in WOMAC A Score Over 26 Weeks | The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A (5 items: measure of pain while walking, using stairs, at night while in bed, sitting or lying, and standing); each item was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. Total WOMAC A score was the sum of 5 item scores and ranges from 0 (none) to 50 (extreme); where lower score represented no pain and higher score represented extreme pain. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | score on a scale | From Baseline up to Week 26 |
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| Secondary | Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks | PTGA (self-assessment of target knee OA condition) was measured using an 11-point NRS ranging from 0 (best possible) to 10 (worst possible), where lower score represented best possible condition and higher score represented worst possible condition. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | score on a scale | From Baseline up to Week 26 |
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| Secondary | Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks | COGA was used by the physicians to perform a global assessment of the participant's target knee OA condition. The response was captured using the 11-point NRS pain intensity rating scale ranging from 0 (best possible) to 10 (worst possible) at the specified time points, where lower score represented best possible condition and higher score represented worst possible condition. | Analysis was performed on mITT population. | Posted | Least Squares Mean | Standard Error | score on a scale | From Baseline up to Week 26 |
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| Secondary | Percentage of Positive WOMAC A1 Responder Over 26 Weeks | WOMAC A1 responder were defined as >=2-point improvement from baseline in the WOMAC A1 NRS. The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. | Analysis was performed on mITT population. | Posted | Number | percentage of participants | Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the on-treatment period (time from the injection of IMP up to Week 26 follow-up visit). | Analysis was performed on safety population which included randomized participants who received at least 1 injection or part of an injection of Hylan G-F 20 or placebo. | Posted | Count of Participants | Participants | From Baseline up to Week 26 |
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AE data was collected from the time of the injection of IMP up to Week 26 follow-up visit.
Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the injection of IMP up to Week 26 follow-up visit). Analysis was performed on safety 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 | Placebo | Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. | 0 | 220 | 10 | 220 | 66 | 220 |
| EG001 | Hylan G-F 20 | Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks. | 0 | 218 | 14 | 218 | 75 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Hepatitis B | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Ovarian Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Lacunar Infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal Adhesions | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Uterine Polyp | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
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| Joint Injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2019 | Jan 19, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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| Participants |
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