Clinical trial NCT00669032: Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee
Official title: Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Lead sponsor: Tedec-Meiji Farma, S.A.
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 446
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Detailed description: To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Eligibility criteria: Inclusion Criteria:

* Patient \> 45 years of age
* Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
* Joint Space Width (JSW) \> 2mm
* Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion Criteria:

* Overweight patients (body mass index \> 32).
* Pregnant and lactating women. Women of child-bearinge age not using effective contraception
* Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
* AINE administration within the 14 days prior to their inclusion in the study.
* Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
* Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
* Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
* Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
* Patients with severely impaired central nervous system.
* Patients with coagulation alterations, despite receiving treatment.
* Patients with secondary osteoarthritis of the knee
* Patients having previously received surgery, including arthroscopy
* Patients with articular inflammatory disease

Primary outcomes:
measure: Responders OARSI 2004 at the End of Follow-up
timeFrame: 40 months
Secondary outcomes:
measure: Responders OARSI 2004 at 7 Months Follow-up Visit
timeFrame: 7 months (6 months after first cycle)
measure: Responders OARSI 2004 at 14 Months Follow-up Visit
timeFrame: 14 months (6 months after second cycle)
measure: Responders OARSI 2004 at 21 Months Follow-up Visit
timeFrame: 21 months (6 months after third cycle)
measure: Responders OARSI 2004 at 27 Months Follow-up Visit
timeFrame: 27 months (12 months after third cycle)
measure: Responders OARSI 2004 at 34 Months Follow-up Visit
timeFrame: 34 months (6 months after fourth cycle)
measure: Pain or Function Scores Reduction 50% (20mm) at the End of Follow-up
timeFrame: 40 months
measure: Overall Pain Reduction 20% (10mm) at the End of Follow-up
timeFrame: 40 months
measure: Function Improvement 20% (10mm) at the End of Follow-up
timeFrame: 40 months
measure: Patient's Global Assessment Increase 20% (10mm) at the End of Follow-up
timeFrame: 40 months
measure: Percentage of Patients Who Consumed Rescue Medication for Osteoarthritis
timeFrame: Throughout the study, an average of 40 months
measure: Mean Daily Dose of Paracetamol Consumption
timeFrame: Throughout the study, an average of 40 months
Other outcomes:
Locations:
Study officials:
name: Federico Navarro Sarabia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navarro-Sarabia F, Coronel P, Collantes E, Navarro FJ, de la Serna AR, Naranjo A, Gimeno M, Herrero-Beaumont G; AMELIA study group. A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project. Ann Rheum Dis. 2011 Nov;70(11):1957-62. doi: 10.1136/ard.2011.152017. Epub 2011 Aug 17.