Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06370156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
Sponsor:
Egymedicalpedia
Organization:
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 (MTX)was 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 (MTX)was 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:
True
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?: