Ignite Creation Date:
2024-05-06 @ 7:04 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02466581
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2015-05-29
Brief Title:
Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Multicenter Randomized Open-label Blinded-assessor Follow-up Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an international Nordic trial designed to compare the safety and efficacy of active conventional therapy ACT and three biologic treatments Certolizumab-pegol Abatacept or Tocilizumab in subjects with early rheumatoid arthritis RA The global aim of this study is to assess and compare two alternative de-escalation strategies in patients who achieved low disease activity during first-line therapy in the NORD-STAR study
Detailed Description:
25 patients have been included in the study of which 1 has had an early termination an 22 have completed the full study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20141705-313 | OTHER | Regional Ethical Review Board | None |
| 2014-002374-36 | EUDRACT_NUMBER | None | None |