OsteoarthritisPhase 4OASISNCT02389452
Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment
A Phase 4 study testing Synvisc-One in people with Osteoarthritis, run by Genzyme, a Sanofi Company.
Trial summary
Primary Objective: To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s). Secondary Objective: To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Synvisc-One
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Sep 2011
- 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
- Male and female participant aged 30 years or older, with active lifestyle.
- The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations.
- The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL] Grade I-III), predominant in the tibiofemoral compartment.
- WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee.
- Participants with bilateral disease may be 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 may also be treated with Synvisc-One and does not need to meet the KL grade knee specific inclusion criteria described above. The other criteria do apply.
- If female, must had a negative urine pregnancy test and continue to use a medically acceptable form of contraception for the duration of the study. Otherwise, females must had been surgically sterile or postmenopausal (as documented in the 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 may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, or chondrocalcinosis).
- History of sepsis in any joint or any clinical concern for a subacute infectious process in the target joint.
- History of surgery in the target knee.
- Planned surgery on any lower extremity joint.
- Clinically significant venous or lymphatic stasis present in the leg(s).
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- 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 IA steroids in the previous 3 months.
- Any contraindication to IA injection, eg, anticoagulant therapy or clinical concern for potential coagulopathy (eg, liver disease).
- Any significant medical condition (eg, significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors (eg, 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.
About this study
Official title: A Multicenter, Prospective, Open-Label Study of the Safety and Efficacy of 6 mL Synvisc-One ® (Hylan G F 20) in Indian Patients With Symptomatic Osteoarthritis of the Knee(s) After Initial and Repeat Treatment
Primary Objective:
To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).
Secondary Objective:
To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
Read the detailed description
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
- Conditions
- Osteoarthritis
- Being tested
- Synvisc-One
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc-OneDrug
Also called GZ402662; hylan G-F 20
intraarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Synvisc-One | Experimental | Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore [measurement of pain while walking on flat surface] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment). Receives: Drug: Synvisc-One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in WOMAC A1 Subscore at Week 26
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
Measured: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).
Secondary outcomes (13)
Change From Baseline in WOMAC A1 Subscore at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
Measured: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC A Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.
Measured: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC B Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.
Measured: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC C Score at Week 52
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Measured: Baseline, Week 52 (missing data imputed by LOCF)
Patient Global Assessment (PTGA) Score at Week 52
PTGA (global 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. Number of participants with different categories of PTGA score at Week 52 are reported.
Measured: Week 52 (missing data imputed by LOCF)
Clinician Observer Global Assessment (COGA) Score at Week 52
COGA (global 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 the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.
Measured: Week 52 (missing data imputed by LOCF).
12-Item Short Form Health Survey (SF-12)
SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.
Measured: Baseline, Week 26, 52
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
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 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.
Measured: Baseline up to Week 52
Time Between Initial and Repeat Synvisc-One Treatment
Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.
Measured: Baseline up to Week 52
Change From Baseline in WOMAC A1 Subscore After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Measured: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC A Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Measured: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC B Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Measured: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC C Score After Repeat Injection
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).
Measured: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389452
- Sponsor's protocol ID
- SYNV03809
- Other IDs
- U1111-1167-6813
- Acronym
- OASIS
- Status last verified
- Aug 2017
- First submitted
- 4 Mar 2015
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-Label Study of the Safety and Efficacy of 6 mL Synvisc-One ® (Hylan G F 20) in Indian Patients With Symptomatic Osteoarthritis of the Knee(s) After Initial and Repeat Treatment
- ClinicalTrials.gov ID
- NCT02389452
- Acronym / sponsor ID
- OASIS / SYNV03809
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 21 May 2015
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 safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).
Secondary Objective:
To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.
Detailed description
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synvisc-One | Experimental | Drug: Synvisc-OneSingle 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore [measurement of pain while walking on flat surface] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female participant aged 30 years or older, with active lifestyle.
- The participant must be able to read, understand, and sign an informed consent form, understand requirements for followup visits, and must be willing to provide information at the scheduled evaluations.
- The participant had a diagnosis of OA of the target knee confirmed by recent X-ray (mild to moderate joint space narrowing and/or osteophytes (ie, Kellgren Lawrence [KL] Grade I-III), predominant in the tibiofemoral compartment.
- WOMAC A1 baseline 100 mm visual analog scale (VAS) score from 40-80 mm (moderate or severe walking pain) in the target knee.
- Participants with bilateral disease may be included in the study with the below strict conditions:
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 may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, or chondrocalcinosis).
- History of sepsis in any joint or any clinical concern for a subacute infectious process in the target joint.
- History of surgery in the target knee.
- 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 |
|---|---|---|
| Synvisc-OneAlso: GZ402662; hylan G-F 20intraarticular injection | Drug | Synvisc-One |
Primary outcome
Change From Baseline in WOMAC A1 Subscore at Week 26
Time frame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).
WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.
13 secondary outcomes
Change From Baseline in WOMAC A1 Subscore at Week 52
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC A Score at Week 52
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC B Score at Week 52
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Change From Baseline in WOMAC C Score at Week 52
Time frame: Baseline, Week 52 (missing data imputed by LOCF)
Patient Global Assessment (PTGA) Score at Week 52
Time frame: Week 52 (missing data imputed by LOCF)
Clinician Observer Global Assessment (COGA) Score at Week 52
Time frame: Week 52 (missing data imputed by LOCF).
12-Item Short Form Health Survey (SF-12)
Time frame: Baseline, Week 26, 52
Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52
Time frame: Baseline up to Week 52
Time Between Initial and Repeat Synvisc-One Treatment
Time frame: Baseline up to Week 52
Change From Baseline in WOMAC A1 Subscore After Repeat Injection
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC A Score After Repeat Injection
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC B Score After Repeat Injection
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Change From Baseline in WOMAC C Score After Repeat Injection
Time frame: Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Synvisc-One in people with Osteoarthritis, run by Genzyme, a Sanofi Company.
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 8 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 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 21 May 2015). 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 WOMAC A1 Subscore at Week 26 (time frame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2017.