Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197026
• Other study ID #: 1139.4
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2014
• Last updated: July 21, 2014
• Start date: October 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. primary completion date: February 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female outpatient aged at least 18 years

• Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale

• Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS

• Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs

• Patient's informed written consent obtained in accordance with French legislation

Exclusion Criteria:

• Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:

• nocturnal disturbances due to knee pain

• morning stiffness over 45 minutes

• increase of knee pain more than 50% within the last week

• articular reddening

• articular heat

• Intra-articular administration of hyaluronic acid in the target knee within the previous year

• Intra-articular administration of hyaluronic acid in the target knee within the three previous months

• Any other intra-articular injection in the target knee within the last 6 months

• Any contraindication to intra-articular injections

• Present or past history of infected target knee joint

• Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee

• Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year

• Planned knee surgery within the nine following month

• Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity

• Known hypersensitivity to avian products

• Presence of lymphatic or venous stasis

• Pregnancy or breastfeeding

• Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance

• Participation in another clinical trial during this study or during the previous month

• Previous participation in this trial

• Patient who requires help concerning shopping or house keeping

• Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Hylan G-F 20

• Standard treatment
Standard drug treatment at the discretion of the investigator

Procedure:
• Physiotherapy

• Hydrotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of knee OA treatment including cost of side effect related to OA treatment		up to 274 days	No
Primary	Area under the curve (AUC) Lequesne index	Index of severity	Day 1, 29, 91, 182 and 274	No
Secondary	Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient		Day 1, 91, 182 and 274	No
Secondary	Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3		Day 1, 91, 182 and 274	No
Secondary	Disease activity assessment by patient and investigator on a VAS		Day 1, 29, 91, 182 and 274	No
Secondary	Acute congestive OA flares assessed through a questionnaire		Day 1, 29, 91, 182 and 274	No
Secondary	Assessment of state of health of the patients with a quality of life questionnaire (SF 12)		Day 1, 91, 182, 274	No
Secondary	Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)		Day 274	No
Secondary	Final global assessment of tolerability by patient and investigator on a four-point VRS		Day 274	No
Secondary	Incidence and intensity of adverse events		up to day 274	No
Secondary	Number of withdrawals due to adverse event		up to day 274	No

External Links

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