Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients

Plaque Psoriasis Clinical Trial

Official title:

Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370156
• Other study ID #: TWEAK in plaque psoriasis
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 10, 2025

Study information

• Verified date: April 2024
• Source: Egymedicalpedia
• Contact: Eisa Mohamed Hegazy, Professor
• Phone: +201094337795
• Email: eisa_mohamed4152[@]med.svu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 10, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.

• Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs

Exclusion Criteria:

• Previously received biologic immunomodulating agents, except for those targeting TNF

• Previously been treated with three or more different TNF inhibitors

• Active, ongoing inflammatory diseases other than PsA

• Active TB (patients with latent TB had to commence treatment for latent TB before study entry)

• A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline

• History of ongoing, chronic or recurrent infections, or evidence of active TB infection

• History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)

• Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation

• Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Adalimumab
To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.

Locations

Country	Name	City	State
Egypt	South Valley Hospitals	Qina

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of psoriasis vulgaris and psoriatic arthritis	to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.	1 year
Secondary	Evaluation of serum TWEAK	To detect the correlation between serum TWEAK the PASI score and the ACR score pre and post Methotrexate and Adalimumab therapy	1 year