Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate Case Control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Psoriasis vulgaris is associated with significant comorbidity including depression increased risk of cardiovascular events diminished quality of life as well as overall increased mortality
Moreover concomitant psoriatic arthritis is present in up to 40 of psoriasis patients or will develop in the future
To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients effective treatment of this immune-mediated systemic inflammatory disease is required
Moreover concomitant psoriatic arthritis is present in up to 40 of psoriasis patients or will develop in the future
To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients effective treatment of this immune-mediated systemic inflammatory disease is required
Detailed Description:
Psoriasis vulgaris is associated with significant comorbidity including depression increased risk of cardiovascular events diminished quality of life as well as overall increased mortality
The cytokine tumor necrosis factor TNF-related weak inducer of apoptosis TWEAK in cooperation with its sole receptor Fn14 is involved in miscellaneous biological and pathological processes
The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines The upregulation of TWEAK and Fn14 occurs in many human skin disorders including cutaneous lupus erythematosus bullous pemphigoid and dermatomyositis There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis
The introduction of anti-tumor necrosis factor-α inhibitors anti-TNF agents has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents
Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis psoriatic arthritis or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks according to recent findings
Methotrexate MTXwas approved for the treatment of psoriasis by the US Food and Drug Administration FDA At present the drug is indicated for the treatment of practically all forms of moderate or severe psoriasis including psoriatic arthritis
The cytokine tumor necrosis factor TNF-related weak inducer of apoptosis TWEAK in cooperation with its sole receptor Fn14 is involved in miscellaneous biological and pathological processes
The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines The upregulation of TWEAK and Fn14 occurs in many human skin disorders including cutaneous lupus erythematosus bullous pemphigoid and dermatomyositis There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis
The introduction of anti-tumor necrosis factor-α inhibitors anti-TNF agents has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents
Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis psoriatic arthritis or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks according to recent findings
Methotrexate MTXwas approved for the treatment of psoriasis by the US Food and Drug Administration FDA At present the drug is indicated for the treatment of practically all forms of moderate or severe psoriasis including psoriatic arthritis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None