Condition category
Musculoskeletal Diseases
Date applied
21/01/2015
Date assigned
11/02/2015
Last edited
13/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The treatment for osteoarthritis (a disorder in which the joints become painful and stiff) consists of drugs (e.g., for pain relief) and non-drug treatments. Injections of hyaluronans, which are not drugs, into the knee is one of the well accepted standards of care for treating symptomatic knee osteoarthritis. The aim in this preliminary study is to assess the beneficial effect of Hymovis®, an innovative hydrogel formulation obtained from a hyaluronic acid derivative (HYADD4®), on the cartilage (soft bone tissue) of patients with knee osteoarthritis.

Who can participate?
Patients aged 40–75 years old with symptomatic knee osteoarthritis and

What does the study involve?
Patients will receive two treatment cycles of Hymovis® at 6 month intervals; each treatment cycle will consist of two intra-articular injections at 1 week intervals. They will have objective measurements of biological and MRI-based imaging markers.

What are the possible benefits and risks of participating?
A potential benefit for patients is relief of pain associated with knee osteoarthritis. The main risks are pain, swelling or infections due to the injection procedure.

Where is the study run from?
Centre Hospitalier Universitaire Brugmann (Belgium), Centre Hospitalier Universitaire Liège (Belgium), Hôpital Lariboisière (France) and Centre Hospitalier Régional Metz (France).

When is the study starting and how long it is expected to run for?
November 2014 to June 2017

Who is funding the study?
Fidia farmaceutici SpA (Italy)

Who is the main contact?
Professor Michel Malaise

Trial website

Contact information

Type

Public

Primary contact

Mr Michel Malaise

ORCID ID

http://orcid.org/0000-0003-3104-800X

Contact details

Centre Hospitalier Universitaire Liège
Rheumatology
Domaine Universitaire du Sart Tilman
Bâtiment B 35
Liege
4000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EQC5.14.02

Study information

Scientific title

Evaluation of the biological and imaging markers of bone and cartilage degradation in patients with knee osteoarthritis receiving intra-articular injections of a hyaluronan derivative Hymovis®: a pilot study

Acronym

Study hypothesis

Hymovis® acts on joints with osteoarthritis by inhibiting the key mechanisms leading to bone and cartilage degradation.

Ethics approval

1. Comité d’Ethique Hospitalier OM 26 (CHU Brugmann), 15/10/2014, Ref.: CE 2014/151
2. Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège, 12/11/2014, 2- Nr. Belge: B707201422130; Ref. 2014/247
3. Comité de Protection des Personnes Ile de France IV, 10/04/2015, Ref. CPP 2015/011
4. Comité d’Ethique Médicale (CHU UCL Mont-Godinne), 22/06/2015, Ref. 43/2015
5. Comité d’Ethique 412 (CHR Citadelle), 17/06/2015, Ref. 1515
6. Agence Nationale de Sécurité du Médicament et des produits de santé, 06/05/2015, ID-RCB : 2015-A00370-49

Study design

Open-label multicentre pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Knee osteoarthritis

Intervention

1. Each patient will be enrolled in the study for 13 months (nine visits)
2. Patients will receive two treatment cycles of Hymovis® at 6 month intervals; each treatment cycle corresponds to two intra-articular injections at 1 week intervals

Intervention type

Drug

Phase

Not Applicable

Drug names

Hymovis

Primary outcome measures

Variation in type II collagen-specific biomarkers: levels will be measured at screening visit, follow-up visits after 1 month and 3 months, and last visit after 12 months

Secondary outcome measures

1. Variation in biomarkers related to cartilage homoeostasis: levels of biomarkers will be measured at the screening visit, follow-up visits after 1 month and 3 months, and at the last visit after 12 months
2. Variation in magnetic resonance imaging (MRI) markers: measured at the screening visit and after 12 months
3. Variation in pain and function: measured with the visual analogue scale at the screening visit, follow-up visits after 1 month and 3 months, and at the last visit after 12 months
4. Response to treatment: measured with the OMERACT–OARSI (Outcome Measures in Rheumatology–Osteoarthritis Research Society International) set of responder criteria at the screening visit, follow-up visits after 1 month and 3 months, and last visit after 12 months
5. Tolerance and satisfaction: measured with adverse events and drop-off rates at the screening visit, follow-up visits after 1 month and 3 months, and end visit after 12 months

Overall trial start date

25/11/2014

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 40–75 years old
2. Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee osteoarthritis associated or not with femoropatellar knee osteoarthritis
3. Clinical and radiological criteria of the American College of Rheumatology
4. Symptomatic for more than 6 months in the most painful knee
5. Radiological Kellgren and Lawrence grade II or III in radiographs from less than 12 months ago
6. Mean knee pain score of the most painful knee at rest over the past 24 hours on the Visual Analogue Scale (0–100) of at least 40 with a washout period for Paracetamol and oral non-steroidal anti-inflammatory drugs depending on the half-life of the drug
7. Able to follow the instructions of the study
8. Signed an informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Bilateral (except asymptomatic and grade I) osteoarthritis of the knee
2. Radiological Kellgren and Lawrence grade I or IV
3. Chondromatosis or villonodular synovitis of the knee
4. Recent trauma (<1 month) of the symptomatic knee
5. Acute inflammatory osteoarthritis
6. Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, haemophilia or haemochromatosis
7. Inflammatory disease
8. Pathologies interfering with the evaluation of osteoarthritis
9. Contraindications to Hymovis®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site
10. Anticoagulants (coumarinic compounds) and heparin

Recruitment start date

25/11/2014

Recruitment end date

25/04/2016

Locations

Countries of recruitment

Belgium, France

Trial participating centre

Centre Hospitalier Universitaire Brugmann
4 Place A. Van Gehuchten
Brussels
1020
Belgium

Trial participating centre

Centre Hospitalier Universitaire Liège
Domaine Universitaire du Sart Tilman Batiment B35
Liège
4000
Belgium

Trial participating centre

Université Paris 7 Denis Diderot-Hopital Laboriboisiere
Centre Viggo Petersen Inserm UMR 1132 2 rue Ambroise Paré
Paris
75010
France

Trial participating centre

Centre Hospitalier Régional Metz Thionville – Hopital Bel Air
1 rue Friscaty
Thionville
BP 60327 57126
France

Trial participating centre

CHR Citadelle de Lège
Boulevard du Douzième de Ligne, 1
Liège
4000
Belgium

Trial participating centre

CHU UCL Namur - Site Mont-Godinne
Avenue Docteur Gaston Therasse, 1
Yvoir
5530
Belgium

Trial participating centre

Hôpital Edouard Herriot – Prévention des Maladies Osseuses
5, Place d’Arsenal Pavillon F
Lyon
69003
France

Trial participating centre

Hôpital Nord Franche-Comté - Site de Belfort
Rue Mulhouse, 14 CS 20 499
Belfort Cedex
90016
France

Sponsor information

Organisation

Fidia Farmaceutici Spa

Sponsor details

Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Fidia Farmaceutici Spa (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be published by 24 months from study conclusion

Intention to publish date

30/06/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 13/04/2016 the following changes were made to the trial record: 1. The overall trial end date was changed from 30/06/2016 to 30/06/2017. 2. The recruitment end date was changed from 25/05/2015 to 25/04/2016.