Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

NCT00669032 | Completed Results

• 2 other identifiers: TM-ME3710/3042006-001854-28
• Study Type: interventional
• Target: 446
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Responders OARSI 2004 at the End of Follow-up

  Percentage of subjects with a clinical response according to Osteaorthritis Research Society International (OARSI) 2004 criteria at the end of follow-up. Patients were classified as responders if the pain or physical function scores decreased at least 50% and at least 20mm on the Visual Analogue Scale (VAS), or if two of the following three findings were recorded: a decrease in pain score of at least 20% or at least 10mm on the VAS, a decrease in physical function score of at least 20% and at least 10mm on the VAS, or an increase in the score of the patient's global assessment by at least 20% and at least 10mm on the VAS. The VAS is set between 0-100mm, higher values represent a worse outcome in all cases except for both patient and physician global assessments where higher values indicate a better outcome.

  40 months

Secondary Outcomes (11)

• Responders OARSI 2004 at 7 Months Follow-up Visit

  7 months (6 months after first cycle)

• Responders OARSI 2004 at 14 Months Follow-up Visit

  14 months (6 months after second cycle)

• Responders OARSI 2004 at 21 Months Follow-up Visit

  21 months (6 months after third cycle)

• Responders OARSI 2004 at 27 Months Follow-up Visit

  27 months (12 months after third cycle)

• Responders OARSI 2004 at 34 Months Follow-up Visit

  34 months (6 months after fourth cycle)

Study Arms (2)

hyaluronic acid

EXPERIMENTAL

Cycles of 5 injections of hyaluronic acid at specified intervals

Device: Hyaluronic acid

Placebo

PLACEBO COMPARATOR

Cycles of 5 injections of saline at specified intervals

Other: Placebo

Interventions

Hyaluronic acid DEVICE

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

hyaluronic acid

Placebo OTHER

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Overweight patients (body mass index \> 32).
• Pregnant and lactating women. Women of child-bearinge age not using effective contraception
• 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

Sponsors & Collaborators

• Tedec-Meiji Farma, S.A.: lead

Related Publications (1)

• 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.

  PMID: 21852252 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Control of rescue medication: patients were asked at every assessment visit about the frequency and doses of consumption, but it was not delivered in hand.

Results Point of Contact

• Title: R&D Director
• Organization: Tedec-Meiji Farma, S.A.

m.gimeno@tedecmeiji.com

918870980

Study Officials

• Federico Navarro Sarabia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: October 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 28, 2023
• Results First Posted: February 15, 2016

Record last verified: 2023-08