Card14gene (rs34367357 ) Polymorphism in Egyptian Psoriatic and Psoriatic Arthritis Patient

NCT ID: NCT06870500

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2026-03-10

Brief Summary

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Psoriasis is a chronic, immune-mediated, multisystemic, inflammatory disease caused by the interaction of multiple susceptibility genes and environmental factors that affects 1-3% of the population worldwide .Psoriasis also is a chronic inflammatory skin disease characterized by scaly indurated erythema.

Psoriatic arthritis (PsA) is an autoimmune and chronic musculoskeletal disorder that is associated with psoriasis of the skin . Its presentation can vary from subtle manifestations to highly destructive forms. Joint pain, stiffness and swelling are the most common symptoms.

Detailed Description

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PsA is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients .

The exact aetiopathogenesis of psoriasis is not completely explained. Pathological mechanism involves skin inflammation and hyperproliferation of keratinocytes induced innate and adaptive immune cells. Genetic, immunological and environmental factors are considered the most important aetiologies.

Psoriasis is a chronic relapsing disease, which often necessitates a long-term therapy. Mild to moderate psoriasis can be treated topically with a combination of glucocorticoids, vitamin D analogues, and phototherapy. Moderate to severe psoriasis often requires systemic treatment. The presence of comorbidities such as psoriasis arthritis is also highly relevant in treatment selection.

Methotrexate (MTX) has remained the backbone of the treatment for moderate to severe psoriasis ever since its first use nearly half a century ago.

Over the years, its high efficacy, low cost, relative ease of administration and usefulness in concomitant psoriatic arthritis have contributed in making MTX the drug of choice in managing severe psoriasis. Although the majority of patients achieve remission of disease activity with MTX, a significant proportion may experience mild and transient adverse effects. From time to time, various guidelines on the use of MTX have correctly and adequately stressed the need for strict monitoring of haematological and hepatic adverse events.

The transcription factor known as nuclear factor of kappa light chain enhancer of activated B cells (NF-κB) controls a large number of genes in immune cells in response to inflammation, infection, and other stimuli. Proinflammatory cytokines, chemokines, and growth factors are among the many genes whose transcription is boosted when the NF-κB pathway is activated. These genes are all implicated in the initiation and maintenance of the inflammatory response in psoriatic illness .

The intracellular scaffold protein known as caspase recruitment domain family member 14 (CARD14) rs34367357 is highly abundant in keratinocytes and mediates NF-κB activation by forming a CBM (CARD14-BCL10-MALT1) signaling complex .

Gain-of-function mutations in CARD14 have been demonstrated to increase the development of the CBM complex in keratinocytes, which causes the NF-κB pathway to become hyperactivated. Neutrophils, dendritic cells, and T cells are then drawn in and activated as a result of the transcription of several chemokines (CCL20, CXCL1, and CXCL2), cytokines (IL-36 and IL-19), and antimicrobial peptides. Two key cytokines in the pathophysiology of psoriasis, IL-17 and IL-22, are downstreamly expressed when activated dendritic cells release IL-23 .

Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

About 20 patients with psoriasis

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

1. Assess the response of psoriasis and psoriatic arthritis to Methotrexate.
2. Assess the relation between Card14 gene(rs 34367357 ) Polymorphism in psoriatic and psoriatic arthritis patients and their clinical response to methotrexate

Group B

About 20 psoriatic arthritis

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

1. Assess the response of psoriasis and psoriatic arthritis to Methotrexate.
2. Assess the relation between Card14 gene(rs 34367357 ) Polymorphism in psoriatic and psoriatic arthritis patients and their clinical response to methotrexate

Group C

About 10 healthy control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Methotrexate

1. Assess the response of psoriasis and psoriatic arthritis to Methotrexate.
2. Assess the relation between Card14 gene(rs 34367357 ) Polymorphism in psoriatic and psoriatic arthritis patients and their clinical response to methotrexate

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Card14 gene(rs 34367357 )

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years and above.
* Patients having psoriasis diagnosed clinically and who have a severity grade of moderate to severe, defined as a Psoriasis Area and Severity Index (PASI) score from 5- 10 % of body surface area, and involvement of greater than 10% of the body surface area (BSA) with or without psoriatic arthritis

Exclusion Criteria

* Patients with other autoimmune conditions (e.g., rheumatoid arthritis, systemic lupus erythematosus).
* Pregnancy and lactation.
* Patients currently undergoing immunosuppressive or systemic therapies.
* Patients with known genetic disorders affect immune system function.
* Patients with liver or kidney impairment.
* Patients with allergy or contraindication to methotrexate.
* Patients with active or uncontrolled infections, including chronic infections like tuberculosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Naguib Ahmed

Resident of Dermatology , venereology and andrology at Faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essam El-Din Abd El-Aziz Mohamed Ahmed Nada, Professor

Role: STUDY_CHAIR

Dermatology, Venereology and Andrology Sohag university

Eisa Mohammed Hegazy, Professor

Role: STUDY_DIRECTOR

• Dermatology Venereology & Andrology Faculty of Medicine, South valley University.

Locations

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Qina University hospital, South Valley University Hospital

Qina, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa Naguib Ahmed, MSc

Role: CONTACT

+201099283315

Soheir Abdel-Hamid Ali

Role: CONTACT

+201066877343

Facility Contacts

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Mohamed Hosny Hassan, Professor

Role: primary

+201098473605

Ebtehal Alaa El-Din Kotop Mohamed, Lecturer

Role: backup

+201066798383

Other Identifiers

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Card14gene polymorphism

Identifier Type: -

Identifier Source: org_study_id

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