Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02765074
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2016-04-19
Brief Title:
Filling Bone Erosions a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Filling Bone Erosions a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
REPAIR
Brief Summary:
Rheumatoid arthritis RA is a chronic inflammatory disease mediated by the production of several cytokines which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss Conventional radiographs CR are considered as the gold standard for diagnosis and follow up of joint changes in RA But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss
High Resolution peripheral QCT HRpQCT enables the detection of erosions less than 05 mm in width or depth at metacarpo-phalangeal MCP joints Using 3-D high resolution analysis of cortical bone erosions this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 6- interleukin plays a major role in inflammatory process and bone damages related to RA Tocilizumab TCZ is a humanized anti-IL-6R monoclonal antibody developed and investigated in several clinical trials in RA This biotherapy in association with methotrexate MTX or given in monotherapy is efficient in RA with inadequate response to MTX or anti-TNF b tumor necrosis factor TCZ reduces dramatically systemic inflammation structural progression and improves clinical symptoms and quality of life
Tocilizumab may help reducing bone erosions periarticular osteopenia and systemic bone loss
High Resolution peripheral QCT HRpQCT enables the detection of erosions less than 05 mm in width or depth at metacarpo-phalangeal MCP joints Using 3-D high resolution analysis of cortical bone erosions this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 6- interleukin plays a major role in inflammatory process and bone damages related to RA Tocilizumab TCZ is a humanized anti-IL-6R monoclonal antibody developed and investigated in several clinical trials in RA This biotherapy in association with methotrexate MTX or given in monotherapy is efficient in RA with inadequate response to MTX or anti-TNF b tumor necrosis factor TCZ reduces dramatically systemic inflammation structural progression and improves clinical symptoms and quality of life
Tocilizumab may help reducing bone erosions periarticular osteopenia and systemic bone loss
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