Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01364389
Status:
TERMINATED
Last Update Posted:
2021-09-17
First Post:
2011-03-10
Brief Title:
A 3-arm Proof of Concept Study of AIN457 ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A 2-week Single-blind Randomized 3-arm Proof of Concept Study of the Effects of AIN457 Anti-IL17 Antibody ACZ885 Canakinumab Anti-IL1b Antibody or Corticosteroids in Patients With Polymyalgia Rheumatica Followed by an Open Label Phase to Assess Safety and Long Term Efficacy
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a two-week single-blinded double-dummy randomized active-controlled parallel group design with a follow-up period up to a total study duration of 6-month non-randomized open-label phase to monitor safety tolerability and in responders flare It is a multicentric multinational study The protocol will seek to enroll a total of 30 patients who will be randomized to the 3 arms at a ratio of 111
Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days or 4 months 112 days after their last biologic dose whichever is greater and followed by unblinded re-dosing in the case of a disease flare
Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days or 4 months 112 days after their last biologic dose whichever is greater and followed by unblinded re-dosing in the case of a disease flare
Detailed Description:
None
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 |
|---|---|---|---|
| 2010-019395-73 | EUDRACT_NUMBER | None | None |