Clinical trial NCT03190369: Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Official title: A 26-week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Study to Evaluate the Efficacy and Safety of a Single Dose of 6 mL of Hylan G-F 20 (Synvisc-One®) in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 440
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks
timeFrame: From Baseline up to Week 26
Secondary outcomes:
measure: Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks
timeFrame: From Baseline up to Week 26
measure: Change From Baseline in WOMAC A Score Over 26 Weeks
timeFrame: From Baseline up to Week 26
measure: Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks
timeFrame: From Baseline up to Week 26
measure: Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks
timeFrame: From Baseline up to Week 26
measure: Percentage of Positive WOMAC A1 Responder Over 26 Weeks
timeFrame: Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Baseline up to Week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 1560001
city: Beijing
country: China
facility: Investigational Site Number 1560005
city: Beijing
country: China
facility: Investigational Site Number 1560020
city: Beijing
country: China
facility: Investigational Site Number 1560009
city: Changchun
country: China
facility: Investigational Site Number 1560012
city: Changsha
country: China
facility: Investigational Site Number 1560013
city: Chengdu
country: China
facility: Investigational Site Number 1560023
city: Guangzhou
country: China
facility: Investigational Site Number 1560016
city: Hohhot
country: China
facility: Investigational Site Number 1560011
city: Kunming
country: China
facility: Investigational Site Number 1560017
city: Nanjing
country: China
facility: Investigational Site Number 1560019
city: Nanjing
country: China
facility: Investigational Site Number 1560021
city: Qingdao
country: China
facility: Investigational Site Number 1560007
city: Shanghai
country: China
facility: Investigational Site Number 1560002
city: Shanghai
country: China
facility: Investigational Site Number 1560003
city: Shanghai
country: China
facility: Investigational Site Number 1560022
city: Taiyuan
country: China
facility: Investigational Site Number 1560018
city: Tianjin
country: China
facility: Investigational Site Number 1560010
city: Tianjin
country: China
facility: Investigational Site Number 1560015
city: Wuhan
country: China
facility: Investigational Site Number 1560006
city: Wuxi
country: China
facility: Investigational Site Number 1560008
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.