Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01219933
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2010-10-11
Brief Title:
A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemraActemra Tocilizumab ACT-ALONE
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached ACT-ALONE
Status:
COMPLETED
Status Verified Date:
2015-01
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:
This open-label single-arm study will assess the use of glucocorticoids GC in daily clinical practice and will evaluate the dose reduction of glucocorticoids once low disease activity is achieved in patients with rheumatoid arthritis tre ated with GC and background RoActemraActemra tocilizumab 8mgkg intravenously every 4 weeks In the non-interventional phase the use of GC in daily clinical Belgian practice will be evaluated and described This period of maximum 6 mont hs will allow those patients to obtain the inclusion criteria for the secondary interventional phase In the interventional phase a systematic GC dose reductio n schedule will be evaluated in patients having achieved low disease activity wh ile receiving the same background therapy with RoActemraActemra 8 mgkg Methyl prednisolone will be given from a starting dose of 1 mg to 20 mg orally d aily and will be tapered down The anticipated study duration is up to 13 months
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 |
|---|---|---|---|
| 2010-019694-15 | None | None | None |