Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02778789
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2016-05-16
Brief Title:
Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers
Status:
COMPLETED
Status Verified Date:
2019-09
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:
Re-Bone
Brief Summary:
Comparing the structural effects of TNFi and tocilizumab on the periarticular bone by performing a comprehensive analysis of the periarticular bone changes in RA patients treated with either TNFi or tocilizumab in a longitudinal Setting using high-resolution peripheral quantitative computed tomography HR-pQCT a very sensitive method for visualizing and quantifying bone microstructure in RA patients Quantitatively assessing the changes of erosions volume osteophytes size and the area of cortical fenestration in a group of TNFi-treated and a group of tocilizumab- treated RA patients
Detailed Description:
Inhibition of tumor necrosis factor alpha TNF-α and of interleukin- 6 receptor IL-6R emerged as highly effective cytokine blocking strategies in the treatment of rheumatoid arthritis RA in the last years Both inhibition of TNF-α TNFi and of the interleukin-6 receptor by tocilizumab ameliorate the signs and symptoms reverse the elevated acute phase response and inhibit the progression of bone erosion in RA patients 1 Despite striking similarities with respect to their efficacy and safety in the treatment of RA TNFi and tocilizumab are two entirely distinct approaches for targeting chronic inflammatory diseases in humans This concept is highlighted by the differential response to TNFi and tocilizumab in other chronic inflammatory diseases such as psoriasis psoriatic arthritis and spondyloarthritis with clinical efficacy of the former but not the latter treatment modality 2 On the other hand tocilizumab has a direct effect on the acute phase response and iron metabolism which is not found with TNFi Therefore subtle differences may exist between TNFi and tocilizumab which are relevant for the long-term treatment of RA patients
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