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

NCT ID: NCT01586338

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-09-30

Brief 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

Detailed Description

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

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Synvisc

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.

Group Type: EXPERIMENTAL

Hylan G-F 20

Intervention Type: DRUG

Intra-articular injection (pre-filled glass syringe)

Interventions

Hylan G-F 20

Intra-articular injection (pre-filled glass syringe)

Intervention Type: DRUG

Other Intervention Names

Synvisc®

Eligibility Criteria

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:

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Shanghai, , China

Countries

China

Other Identifiers

U1111-1129-3321

Identifier Type: OTHER

Identifier Source: secondary_id

EFC13912

Identifier Type: OTHER

Identifier Source: secondary_id

SYNVIL06244

Identifier Type: -

Identifier Source: org_study_id