Ignite Creation Date:
2024-05-06 @ 1:01 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01713842
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2012-09-17
Brief Title:
Tocilizumab Effect iN pOlymyalgia Rheumatica
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica PMR
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:
TENOR
Brief Summary:
Phase 1
Patients are treated with infusions of Tocilizumab TCZ for 3 months Clinical evaluation is performed using PMR-AS
The PMR-AS is computed by summing the 5 variables after multiplying by 01 for weighting purposes PMR-AS activity scale AS C reactive protein CRP mgdl patient scale VASp 0-10 scale physician scale VASph 0-10 scale morning stiffnessMST min01 elevation of upper limbs EUL 0-3 scale
At the end of the phase 1the patients stop TCZ and entered in phase 2 at week 12
Phase 2
All the patients are included in the phase 2 and treated with glucocorticoid GCfor 3 months Two arms are possible according to the PMR-AS Either the classical GC treatment 03mgkg either a low dose group of GC015mgkg
Patients are treated with infusions of Tocilizumab TCZ for 3 months Clinical evaluation is performed using PMR-AS
The PMR-AS is computed by summing the 5 variables after multiplying by 01 for weighting purposes PMR-AS activity scale AS C reactive protein CRP mgdl patient scale VASp 0-10 scale physician scale VASph 0-10 scale morning stiffnessMST min01 elevation of upper limbs EUL 0-3 scale
At the end of the phase 1the patients stop TCZ and entered in phase 2 at week 12
Phase 2
All the patients are included in the phase 2 and treated with glucocorticoid GCfor 3 months Two arms are possible according to the PMR-AS Either the classical GC treatment 03mgkg either a low dose group of GC015mgkg
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