Clinical trial NCT00131352: A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
Official title: A Multi-Centre, Parallel, Double-Blind, Blinded Evaluator, Randomised, Placebo-Controlled Evaluation of the Efficacy and Safety of a Single Dose of 6 mL of Synvisc in Patients With Symptomatic Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Musculoskeletal Diseases
Keywords: Osteoarthritis of the knee
Musculoskeletal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 253
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is to evaluate the safety and efficacy of hylan G-F 20 (Synvisc) in patients with symptomatic knee osteoarthritis (OA). Patients will be given 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control), with a possible repeat treatment with Synvisc after the week 26 visit.

Detailed description: The trial included an initial 26 week treatment with 6 mL of hylan G-F 20 (Synvisc) (or a phosphate buffered saline control) followed by a 4 week repeat treatment of Synvisc.

Eligibility criteria: Inclusion Criteria:

* Patient with documented diagnosis of primary osteoarthritis (OA) of the target knee made at least 3 months prior to Screening,
* Has radiographic evidence of OA in the tibio-femoral compartment of the target, knee with at least 1 definite osteophyte and a measureable joint space, as diagnosed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
* Has continued target knee pain despite conservative treatment (e.g. weight reduction, physical therapy, analgesics),
* Has pain in the target knee as demonstrated by a score of 2 or 3 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale ,
* Has a mean score of 1.5 to 3.5 on the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale.
* Inclusion Criteria for Repeat Phase: Must have no major safety concerns during the first course of treatment as assessed by the Investigator; Must have a WOMAC LK 3.1 A score of at least 1.

Exclusion criteria:

* Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the patello-femoral compartment of the target knee confirmed by standard X-rays taken not longer than 3 months prior to Screening, and before any baseline assessment,
* Has clinically apparent tense effusion of the target knee,
* Has had viscosupplementation in any joint including the target knee within 9 months prior to Screening,
* Has concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active infection, etc.,)
* Symptomatic OA of the contralateral knee or of either hip that is not responsive to paracetamol and requires other therapy,
* Has related hypersensitivities to avian proteins and/or any components of hyaluronan-based injection devices,

Primary outcomes:
measure: Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
timeFrame: Day 0, up to week 26
Secondary outcomes:
measure: Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
timeFrame: Day 0, Week 26
measure: Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
timeFrame: Week 26
measure: Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
timeFrame: Day 0, up to week 26
measure: Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
timeFrame: Day 0, Week 26
measure: Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
timeFrame: Week 26
measure: Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
timeFrame: Week 26
measure: Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
timeFrame: Week 26
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gastuisberg Leuven
city: Liege
country: Belgium
facility: CHU Liege
city: Brno
country: Czech Republic
facility: Faculty Hospital Bohunice
city: Prague 2
country: Czech Republic
facility: Institute of Rheumatology
city: Prague 4
country: Czech Republic
facility: Faculty Thomayer Hospital
city: Prague
country: Czech Republic
facility: Faculty Hospital Motol
city: Creteil Cedex
country: France
facility: Hopital Henri Mondor
city: Limoges Cedex
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: Hopital de la Conception
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil
city: Tours Cedex
country: France
facility: CHU Hopital Trousseau
city: Neuss
country: Germany
facility: Johanna-Etienne Krankenhaus
city: Amsterdam
country: Netherlands
facility: AMC/UVA
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Trafford General Hospital
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.