Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01491815
Status:
UNKNOWN
Last Update Posted:
2022-07-08
First Post:
2011-12-08
Brief Title:
Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Multicenter Randomized Open-label Blinded-assessor Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments and Two De-escalation Strategies in Patients Who Respond to Treatment
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 Sweden Finland Norway Denmark Iceland and the Netherlands trial designed to compare the safety and efficacy of active conventional therapy ACT and three biologic treatments in subjects with early rheumatoid arthritis RA The global aim of this study is to assess and compare
1 the proportion of subjects who achieve remission with ACT versus three different biologic therapies Certolizumab-pegol Abatacept or Tocilizumab
2 two alternative de-escalation strategies in patients who respond to first-line therapy
1 the proportion of subjects who achieve remission with ACT versus three different biologic therapies Certolizumab-pegol Abatacept or Tocilizumab
2 two alternative de-escalation strategies in patients who respond to first-line therapy
Detailed Description:
After completed enrollment a total of 812 patients were included in the study
371 of the included patients have entered treatment part 2 256 patients have exited the study after treatment part 1 207 patients have had early termination and 322 patients have completed the full study
371 of the included patients have entered treatment part 2 256 patients have exited the study after treatment part 1 207 patients have had early termination and 322 patients 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 |
|---|---|---|---|
| 2011-004720-35 | EUDRACT_NUMBER | None | None |
| 20112069-314 | OTHER | Regional Ethical Review Board | None |