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

Osteoarthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586338
• Other study ID #: SYNVIL06244
• Secondary ID: U1111-1129-3321E
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2012
• Last updated: January 27, 2016
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion criteria :

1. 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)

2. WOMAC A1 baseline 100 mm Visual Analog Score (VAS) between 40-80 mm (moderate or severe walking pain) in the Target knee

3. 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

4. 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

Exclusion criteria:

1. Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability

2. Concomitant inflammatory or any other disease/condition which might affect joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc)

3. History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint

4. History of surgery in the target knee (if done < 6 months)

5. Planned surgery on any lower extremity joint

6. Presence of clinically significant venous or lymphatic stasis in the leg(s)

7. Clinically apparent tense effusion or inflammation at the target knee

8. Skin disease or infection in the area of the injection site

9. Any musculoskeletal condition that would impede measurement of efficacy at the target knee

10. Pregnant or lactating women

11. Hypersensitivities to avian proteins and/or any components of hyaluronan-based injection

12. Treatment with any Hyaluronic Acid (HA) or derivatives in the previous 6 months.

13. Treatment with Intra-Articular (IA) steroid in the previous 3 months

14. Any contra-indication to IA injection e.g., anticoagulant therapy or clinical concern for potential coagulopathy (e.g. liver disease)

15. 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Hylan G-F 20
Intra-articular injection (pre-filled glass syringe)

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shangai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])	No
Primary	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.	Up to Week 26	Yes
Secondary	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.	Baseline, Week 8 and Week 12 (missing data imputed by LOCF)	No
Secondary	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.	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	No
Secondary	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.	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	No
Secondary	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.	Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)	No
Secondary	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.	Baseline up to Week 26	No