Clinical trial NCT01586338: A Study of the Efficacy and Safety of Synvisc® in Chinese Subjects With Symptomatic Osteoarthritis of the Knee(s)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 237
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

   * 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.

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26
timeFrame: Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])
measure: Overview of Adverse Events (AE)
timeFrame: Up to Week 26
Secondary outcomes:
measure: Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12
timeFrame: Baseline, Week 8 and Week 12 (missing data imputed by LOCF)
measure: Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26
timeFrame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
measure: Patient Global Assessment (PTGA) Score
timeFrame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
measure: Clinical Observer Global Assessment (COGA) Score
timeFrame: Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)
measure: Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26
timeFrame: Baseline up to Week 26
Other outcomes:
Locations:
city: Shangai
country: China
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: