Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee

NCT ID: NCT03190369

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2019-01-28

Brief Summary

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:

• To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day average score of WOMAC A1 pain sub-score in comparison to an IA placebo injection over 26 weeks.
• To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by WOMAC A, patient global assessment (PTGA) and clinical observer global assessment (COGA) in comparison to an IA placebo injection over 26 weeks.
• To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in comparison to an IA placebo injection over 26 weeks. Response was defined as WOMAC A1 greater than or equal to (>=) 2-point improvement from baseline on NRS.
• To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to an IA placebo injection over 26 weeks.

Detailed Description

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: Solution for injection

Route of administration: Intra articular

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.

Group Type: EXPERIMENTAL

Hylan G-F 20 (GZ402662/SAR402662)

Intervention Type: DEVICE

Pharmaceutical form: Solution for injection

Route of administration: Intra articular

Interventions

Hylan G-F 20 (GZ402662/SAR402662)

Pharmaceutical form: Solution for injection

Route of administration: Intra articular

Intervention Type: DEVICE

Placebo

Pharmaceutical form: Solution for injection

Route of administration: Intra articular

Intervention Type: DRUG

Other Intervention Names

Synvisc-One

Eligibility Criteria

Inclusion Criteria

• Symptomatic OA of the target knee joint with WOMAC A1 NRS score of >=4.0 and less than or equal to (<=) 8.0 as recorded in the baseline period.
• Confirmed by standard X-rays performed within 3 months prior to screening visit: modified Kellgren-Lawrence Numerical Grading System of Grade I-III in the target knee joint.
• According to the American College of Rheumatology (ACR) Criteria.
• With failure to respond adequately to conservative non-pharmacologic therapy and/or simple analgesics, such as acetaminophen.
• Participant was willing and was able to provide signed informed consent prior to any study related procedures being performed.

Exclusion Criteria

• The score of contralateral knee pain (if present) >3.0 NRS at screening visit.
• Ipsilateral hip OA.
• Participant with systemic corticosteroids within 12 weeks prior to screening visit.
• Participant with injection of IA corticosteroids in the target knee joint within 26 weeks prior to screening visit.
• Concurrent chronic pain conditions with pain score >3.0 NRS at screening, or peripheral or central neuropathy that may affect sensation of the target knee area, including but not limited to back pain, hip pain, disc herniation, sciatica, diabetic neuropathy, post-stroke pain or fibromyalgia.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 1560001

Beijing, , China

Investigational Site Number 1560005

Beijing, , China

Investigational Site Number 1560020

Beijing, , China

Investigational Site Number 1560009

Beijing, , China

Investigational Site Number 1560012

Changchun, , China

Investigational Site Number 1560013

Changsha, , China

Investigational Site Number 1560023

Chengdu, , China

Investigational Site Number 1560016

Guangzhou, , China

Investigational Site Number 1560011

Hohhot, , China

Investigational Site Number 1560017

Kunming, , China

Investigational Site Number 1560019

Nanjing, , China

Investigational Site Number 1560021

Nanjing, , China

Investigational Site Number 1560007

Qingdao, , China

Investigational Site Number 1560002

Shanghai, , China

Investigational Site Number 1560003

Shanghai, , China

Investigational Site Number 1560022

Shanghai, , China

Investigational Site Number 1560018

Taiyuan, , China

Investigational Site Number 1560010

Tianjin, , China

Investigational Site Number 1560015

Tianjin, , China

Investigational Site Number 1560006

Wuhan, , China

Investigational Site Number 1560008

Wuxi, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33964907 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EFC12723

Identifier Type: -

Identifier Source: org_study_id

U1111-1131-0507

Identifier Type: OTHER

Identifier Source: secondary_id