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

NCT02389452 | Completed Phase 4 Results

• 2 other identifiers: SYNV03809U1111-1167-6813
• Study Type: interventional
• Target: 394
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, Week 52 (missing data imputed by LOCF)

• Change From Baseline in WOMAC A Score at Week 52

  Baseline, Week 52 (missing data imputed by LOCF)

• Change From Baseline in WOMAC B Score at Week 52

  Baseline, Week 52 (missing data imputed by LOCF)

• Change From Baseline in WOMAC C Score at Week 52

  Baseline, Week 52 (missing data imputed by LOCF)

• Patient Global Assessment (PTGA) Score at Week 52

  Week 52 (missing data imputed by LOCF)

Study Arms (1)

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).

Drug: Synvisc-One

Interventions

Synvisc-One DRUG

intraarticular injection

Also known as: GZ402662; hylan G-F 20

Synvisc-One

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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.
• 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).
• 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).

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

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: March 4, 2015
• First Posted: March 17, 2015
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 7, 2017
• Results First Posted: May 21, 2015

Record last verified: 2017-08