LIPIOJOINT-2 : A randomized sham-controlled, double blind, multicenter trial on the effect of Genicular Arteries Embolization in symptomatic knee osteoarthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

30 Sep 2024 → ongoing

Decision date (initial)

2024-05-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-508844-24-00

ClinicalTrials.gov

NCT06497140

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Assess GAE efficacy using an ethiodized oil-based emulsion versus a sham procedure, by comparing the 3-months effect on knee pain in patients with symptomatic knee osteoarthritis.

Secondary objectives 15

1. • Knee pain assessed by VAS pain score at 1, 6 and 12 months after randomization
2. • Patient’s global assessment of her/his health at 1, 3, 6 and 12 months after randomization
3. • Patient’s WOMAC index, and sub-scales (knee pain, function and stiffness) assessment at 1, 3, 6 and 12 months after randomization
4. • Patient’s KOOS index, and sub-scales (knee pain, function, symptoms, sport, quality of life and stiffness) assessment at D0 and 3 months after randomization
5. • Patient’s HAD index, and sub-scales (anxiety and depression) assessment at D0 and 3 months after randomization
6. • Semi-quantitative MRI assessment of KOA of the target knee before randomization and at 6 months
7. • Pain medication at 1, 3, 6 and 12 months after randomization
8. • Non-pharmacological treatments at 1, 3, 6 and 12 months
9. • Responder patients according to OMERACT-OARSI set of responder criteria (1) at 3, 6 and 12 months
10. • Patients reaching acceptable symptom state (PASS) (2) at 3, 6 and 12 months
11. • Occurrence of adverse events and serious adverse events at 1, 3, 6 and 12 months
12. • Occurrence of events of interest in the target knee in the 2 groups at 6 and 12 months
13. • Incremental efficiency of GAE compared to sham treatment.
14. • Patient’s functional priorities concerning disability using the 3-items McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) global score at D0 and 3 months after randomization
15. • Identification of predictive factors of response according to OMERACT-OARSI at 3 months

Conditions and MedDRA coding

Knee OsteoArthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. • Age 40 – 90 years
2. • Diagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (4)
3. • Radiographic Kellgren and Lawrence score ≥ 2 (5)
4. • VAS pain score ≥ 40 mm (scale 0-100 mm)
5. • Patient not eligible to knee surgery
6. • For woman of childbearing potential: negative bêta-HCG before randomization
7. • Social security affiliation
8. • Signed informed consent
9. • Good understanding of the French language
10. · Previous intra-articular injection in the target knee

Exclusion criteria 18

1. • Intra-articular injection of any product in the target joint within 3 months before embolization
2. • Ipsilateral symptomatic hip OA
3. • Treated hyperthyroidism
4. • Known severe allergy to Lipiodol® and/or iodine contrast medium
5. • Known moderate to severe kidney failure (creatinine clearance < 45 ml/min)
6. · Known right-to-left cardiac shunt or intra-tumoral vascular shunt
7. · Asthma attack in the 8 days before randomization
8. · Exploration or treatment with radioactive iodine scheduled within 1 month after randomization
9. · Symptomatic atheromatous lesion in the ipsilateral limb
10. • Patient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)
11. • Vulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)
12. • Patient under exclusion period in another trial
13. • Patient on AME (state medical aid)
14. • Prior ipsilateral partial or total knee replacement
15. • Any inflammatory joint disease other than osteoarthritis
16. • Any contra-indication to puncture of the femoral artery
17. • Current treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside
18. • Regular intake of painkillers (except topical administration) for a pathology other than osteoarthritis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the change of the Visual Analogue Scale (VAS) pain score between randomization and 3 months (0–100 mm: 0 = No Pain, 100 = Worst Possible Pain).

Secondary endpoints 15

1. • Change of the VAS pain score at 1, 6 and 12 months after randomization
2. • Change of the patient’s global assessment of her/his health measured by the VAS of EQ-5D questionnaire at 1, 3, 6 and 12 months after randomization
3. • Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score and sub-scores (pain, function, stiffness) at 1, 3, 6 and 12 months after randomization
4. • Change of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores (knee pain, function, symptoms, sport, quality of life and stiffness) at D0 and 3 months after randomization
5. • Change of the Hospital Anxiety and Depression (HAD) scale total score and sub-scores (anxiety and depression) at D0 and 3 months after randomization
6. • Change in semi-quantitative MRI scoring (Whole-Organ Magnetic Resonance Imaging Score [WORMS], Knee Osteoarthritis Scoring System [KOSS], Boston-Leeds Osteoarthritis Knee Scoring [BLOKS], MRI Osteoarthritis Knee Score [MOAKS]) (3) of the knee at 6 months after randomization
7. • Description of pain medication at 1, 3, 6 and 12 months
8. • Description of non-pharmacological treatments at 1, 3, 6 and 12 months
9. • Number of responder patients under OMERACT-OARSI definition (1) in both groups at 3, 6 and 12 months.
10. • Number of patients reaching an acceptable symptom state at 3, 6 and 12 months.
11. • Number and description of AE/SAE at 1, 3, 6 and 12 months
12. • Number of events in the target knee including intra-articular injection, GAE, knee surgery at 6 and 12 months
13. • Medico-economic study: incremental cost-utility ratio
14. • Change of patient’s 3-item priority function McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) global score at D0 and 3 months after randomization.
15. • The following baseline characteristics will be considered as potential predictors of the 3‑month OMERACT–OARSI response: age, sex, Kellgren and Lawrence score, body mass index (BMI), VAS pain score, and the semi‑quantitative MRI assessments.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Marc SAPOVAL (Coordinating investigator)

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Touria EL AAMRI

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 24 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications