Effects of Hymovis® injections in patients with osteoarthritis of the knee
| ISRCTN | ISRCTN12227846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12227846 |
| Secondary identifying numbers | EQC5.14.02 |
- Submission date
- 21/01/2015
- Registration date
- 11/02/2015
- Last edited
- 20/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Public
Centre Hospitalier Universitaire Liège
Rheumatology
Domaine Universitaire du Sart Tilman
Bâtiment B 35
Liege
4000
Belgium
 ORCID ID |
0000-0003-3104-800X |
|---|
Study information
| Study design | Open-label multicentre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study hypothesis | Hymovis® acts on joints with osteoarthritis by inhibiting the key mechanisms leading to bone and cartilage degradation. |
| Ethics approval(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hymovis |
| Primary outcome measure | 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 study start date | 25/11/2014 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 46 |
| 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 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
Study participating centres
Brussels
1020
Belgium
Batiment B35
Liège
4000
Belgium
2 rue Ambroise Paré
Paris
75010
France
Thionville
BP 60327 57126
France
Liège
4000
Belgium
Yvoir
5530
Belgium
Pavillon F
Lyon
69003
France
CS 20 499
Belfort Cedex
90016
France
Sponsor information
Research organisation
Via Ponte della Fabbrica 3/A
Abano Terme
35031
Italy
"ROR" |
https://ror.org/00dy5wm60 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be published by 24 months from study conclusion |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/06/2019 | 20/06/2019 | Yes | No |
Editorial Notes
20/06/2019: Publication reference and total final enrolment number added.
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.
