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 (OASIS)

Genzyme

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Synvisc-One

Study type: Interventional

Funder types: Industry

Identifiers

NCT02389452

U1111-1167-6813 (Other Identifier)

SYNV03809

Details and patient eligibility

About

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.

Full description

A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.

Enrollment: 394 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  • 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 may also be treated with Synvisc-One and does not need to meet the KL grade knee specific inclusion criteria described above. The other criteria do apply.

• 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.

Exclusion criteria

• 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).
• Any significant medical condition (eg, significant psychiatric or neurological disorders or active alcohol/drug abuse), any medical condition that is unstable/poorly controlled or other factors (eg, 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

394 participants in 1 patient group

Synvisc-One

Experimental group

Description:

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).

Treatment:

Drug: Synvisc-One