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

NCT01586338 | Completed Phase 4 Results

• 3 other identifiers: SYNVIL06244U1111-1129-3321EFC13912
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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])

• 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

Secondary Outcomes (5)

• Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12

  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

  Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)

• Patient Global Assessment (PTGA) Score

  Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)

• Clinical Observer Global Assessment (COGA) Score

  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

  Baseline up to Week 26

Study Arms (1)

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.

Drug: Hylan G-F 20

Interventions

Hylan G-F 20 DRUG

Intra-articular injection (pre-filled glass syringe)

Also known as: Synvisc®

Synvisc

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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)
• 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)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

hylan

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 26, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 24, 2016
• Results First Posted: February 24, 2016

Record last verified: 2016-01

Locations

CN (1)