Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Rheumatoid arthritis
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 10 Nov 2017 → ongoing
- Decision date (initial)
- 2023-09-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503474-20-00
- EudraCT number
- 2017-003425-15
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid arthritis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Nordre Ringvej 57
- City
- Glostrup
- Postcode
- 2600
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Mikkel Østergaard
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Mikkel Østergaard
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 100 | 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 |
|---|---|---|---|---|---|
| Denmark | 2017-11-10 | 2019-09-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | Denmark | Acceptable 2023-08-28
|
2023-09-07 |