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

A Phase 4 study testing Hylan G-F 20 in people with Osteoarthritis, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Hylan G-F 20
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 237 participants
Where: 1 siteChina
Study dates: Mar 2012to Sep 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Sanofi-Aventis Administrative Office
Shanghai

Other trials in China

About this study

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)

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

Read the detailed description

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

Conditions: Osteoarthritis
Being tested: Hylan G-F 20
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hylan G-F 20Drug
Also called Synvisc®
Intra-articular injection (pre-filled glass syringe)

Study groups in NCT01586338
Study group	Role	What they receive
Synvisc	Experimental	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. Receives: Drug: Hylan G-F 20

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
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.
Measured: Up to Week 26

Secondary outcomes (5)

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.
Measured: Baseline, Week 8 and Week 12 (missing data imputed by LOCF)
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.
Measured: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
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.
Measured: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
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.
Measured: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
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.
Measured: Baseline up to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Sep 2013

First posted26 Apr 2012 (estimated)
Study startMar 2012
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01586338
Sponsor's protocol ID: SYNVIL06244
Other IDs: U1111-1129-3321, EFC13912
Status last verified: Jan 2016
First submitted: 23 Apr 2012
Last updated: 24 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01586338
Acronym / sponsor ID: SYNVIL06244
Conditions: Osteoarthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 26 Apr 2012 (estimated)
Results: Posted 24 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Synvisc	Experimental	Drug: Hylan G-F 20Three 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.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:
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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hylan G-F 20Also: Synvisc®Intra-articular injection (pre-filled glass syringe)	Drug	Synvisc

Primary outcome

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
Time frame: 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)
Time frame: 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.

5 secondary outcomes

Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
Time frame: Baseline, Week 8 and Week 12 (missing data imputed by LOCF)
Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
Time frame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Patient Global Assessment (PTGA) Score
Time frame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Clinical Observer Global Assessment (COGA) Score
Time frame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
Time frame: Baseline up to Week 26

Results and safety

Results posted to the registry on 24 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synvisc	237	229

Primary outcome: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26

Time frame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]). Mean (Standard Deviation). Unit: mm

Measure	Synvisc n = 232
Value	-33.0 (17.71)

Synvisc: p <0.0001, Paired t-test
Synvisc: p <0.0001, Sign Rank Test

Population analysed: Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).

Primary outcome: Overview of Adverse Events (AE)

Time frame: Up to Week 26. Number. Unit: percentage of participants

Measure	Synvisc n = 237
AEs	27.8
Treatment-emergent AEs	27.8
Treatment-emergent SAEs	1.7
Treatment-emergent AEs Lead to Discontinuation	0.4

Population analysed: Safety Set included all participants who received at least one injection of Synvisc.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 26) regardless of seriousness or relationship to investigational product.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synvisc	4 of 237 (1.7%)	66 of 237 (27.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hylan G-F 20 in people with Osteoarthritis, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26 (time frame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.