Clinical trial NCT02197026: Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cost of knee OA treatment including cost of side effect related to OA treatment
timeFrame: up to 274 days
measure: Area under the curve (AUC) Lequesne index
timeFrame: Day 1, 29, 91, 182 and 274
Secondary outcomes:
measure: Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
timeFrame: Day 1, 91, 182 and 274
measure: Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
timeFrame: Day 1, 91, 182 and 274
measure: Disease activity assessment by patient and investigator on a VAS
timeFrame: Day 1, 29, 91, 182 and 274
measure: Acute congestive OA flares assessed through a questionnaire
timeFrame: Day 1, 29, 91, 182 and 274
measure: Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
timeFrame: Day 1, 91, 182, 274
measure: Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
timeFrame: Day 274
measure: Final global assessment of tolerability by patient and investigator on a four-point VRS
timeFrame: Day 274
measure: Incidence and intensity of adverse events
timeFrame: up to day 274
measure: Number of withdrawals due to adverse event
timeFrame: up to day 274
Other outcomes:
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