Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642207
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Effect of IL17 Inhibitor in Comparison With Anti-TNF in Patients With Ankylosing Spondylitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of IL17 Inhibitor in Comparison With Anti-TNF- α on Platelet Count and Its Association With Disease Activity in Patients With Ankylosing Spondylitis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ankylosing spondylitis AS is a chronic inflammatory autoimmune disease characterized by axial bone inflammation The main clinical manifestations include back pain and progressive spinal rigidity as well as inflammation of the hips shoulders and peripheral joints Also extra-articular manifestations such as psoriasis uveitis and inflammatory bowel disease IBD
Indicators of inflammation such as erythrocyte sedimentation rate ESR and Creactive protein CRP which are typically elevated in AS patients particularly when peripheral joints are involved these tests ultimately do not reflect the disease process and have limited sensitivity and specificity Disease activity in AS has been measured by the Bath Ankylosing Spondylitis Disease Activity Index BASDAI which includes only patient-reported measures The assessment of Spondyloarthritis International society ASAS developed a new AS disease activity score ASDAS that combines patient-reported assessments with erythrocyte sedimentation rate ESR or C-reactive protein CRP Although platelets play important functions in hemostasis and thrombosis their functions in controlling immunity and inflammation have drawn more attention recently Platelets are known to have a key role in controlling inflammatory processes in a variety of pathological states Overactivated platelets can induce inflammation which in turn can increase the risk of the development of atherosclerosis thrombosis and cardiovascular disorders Inflammatory diseases including inflammatory bowel disease IBD have platelets play a crucial role in their development The first-line recommended treatment for active AS is NSAIDs
Tumor necrosis factor TNF inhibitors have completely changed the therapy options for patients who have not improved despite receiving standard NSAID treatment TNF inhibitors can however cause tolerability problems in certain patients or inadequate responses in others and their effectiveness may gradually diminish Interleukin IL-17 inhibitors are among the new therapeutic alternatives that are currently accessible for these individuals
Indicators of inflammation such as erythrocyte sedimentation rate ESR and Creactive protein CRP which are typically elevated in AS patients particularly when peripheral joints are involved these tests ultimately do not reflect the disease process and have limited sensitivity and specificity Disease activity in AS has been measured by the Bath Ankylosing Spondylitis Disease Activity Index BASDAI which includes only patient-reported measures The assessment of Spondyloarthritis International society ASAS developed a new AS disease activity score ASDAS that combines patient-reported assessments with erythrocyte sedimentation rate ESR or C-reactive protein CRP Although platelets play important functions in hemostasis and thrombosis their functions in controlling immunity and inflammation have drawn more attention recently Platelets are known to have a key role in controlling inflammatory processes in a variety of pathological states Overactivated platelets can induce inflammation which in turn can increase the risk of the development of atherosclerosis thrombosis and cardiovascular disorders Inflammatory diseases including inflammatory bowel disease IBD have platelets play a crucial role in their development The first-line recommended treatment for active AS is NSAIDs
Tumor necrosis factor TNF inhibitors have completely changed the therapy options for patients who have not improved despite receiving standard NSAID treatment TNF inhibitors can however cause tolerability problems in certain patients or inadequate responses in others and their effectiveness may gradually diminish Interleukin IL-17 inhibitors are among the new therapeutic alternatives that are currently accessible for these individuals
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