Overview
Sponsor-declared trial summary
Patients with Rheumatoid Arthritis (RA) who, despite treatment with stable doses (for at least 3 months) of disease-modifying antirheumatic drugs (DMARDs, conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for intra-articular (IA) injection in a knee, shoulder, ankle, wrist or elbow.
Key facts
- Sponsor
- Philogen S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 29 Sep 2025 → ongoing
- Decision date (initial)
- 2025-04-22
- 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
Patients with Rheumatoid Arthritis (RA) who, despite treatment with stable doses (for at least 3 months) of disease-modifying antirheumatic drugs (DMARDs, conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for intra-articular (IA) injection in a knee, shoulder, ankle, wrist or elbow.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Philogen S.p.A.
- Sponsor organisation
- Philogen S.p.A.
- Address
- Piazza La Lizza 7
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Louis Pluss
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Louis Pluss
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 42 | 2 |
| 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 |
|---|---|---|---|---|---|
| Italy | 2025-09-29 | 2026-03-04 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Italy | Acceptable 2025-04-15
|
2025-04-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-07 | Italy | Acceptable 2025-12-03
|
2025-12-10 |