Overview
Sponsor-declared trial summary
Arthrose digitale répondant aux critères de classification de l’American College of Rheumatology (ACR), touchant au moins deux articulations interphalangiennes proximales (IPP) et/ou distales (IPD) présentant un stade radiologique de Kellgren-Lawrence (KL) ≥ 2 et symptomatique dans les 3 derniers mois.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 5 Dec 2024 → ongoing
- Decision date (initial)
- 2024-07-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Arthrose digitale répondant aux critères de classification de l’American College of Rheumatology (ACR), touchant au moins deux articulations interphalangiennes proximales (IPP) et/ou distales (IPD) présentant un stade radiologique de Kellgren-Lawrence (KL) ≥ 2 et symptomatique dans les 3 derniers mois.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Grenoble Alpes
- Sponsor organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Address
- Av De Kimberley, Bp 185 Bp 185
- City
- Echirolles
- Postcode
- 38130
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Dr Xavier ROMAND
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Dr Xavier ROMAND
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-12-05 | 2025-01-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | France | Acceptable 2024-07-15
|
2024-07-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-05 | France | Acceptable 2026-03-11
|
2026-03-11 |