Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424346
Status:
COMPLETED
Last Update Posted:
2014-02-10
First Post:
2007-01-17
Brief Title:
Efficacy Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A 12-week Multicenter Randomized Double-blind Placebo-controlled Parallel Group Dose-finding Study to Evaluate the Efficacy Safety and Tolerability of ACZ885 Anti-interleukin-1beta Monoclonal Antibody With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
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:
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885 added on to stable methotrexate MTX therapy greater than or equal to 75 mgweek compared to placebo in patients with active rheumatoid arthritis RA The study investigated the magnitude of effect as well as onset of effect for the different dose regimens
The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab ACZ885 in patients with active RA CACZ885A2201E1 evaluated this objective in patients who had participated in the core study CACZ885A2201 and CACZ885A2201E2 did the same in patients who completed the first extension study
The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab ACZ885 in patients with active RA CACZ885A2201E1 evaluated this objective in patients who had participated in the core study CACZ885A2201 and CACZ885A2201E2 did the same in patients who completed the first extension study
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 |
|---|---|---|---|
| CACZ885A2201E2 | None | None | None |
| CACZ885A2201E1 | None | None | None |