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RecruitingNCT06870500Updated Mar 11, 2025

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

An interventional study of Methotrexate and Placebo in Psoriatic Arthritis, sponsored by South Valley University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the detailed description

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 .

02

Conditions studied

  • Psoriatic Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Group A

    About 20 patients with psoriasis

    Drug: Methotrexate

  • Active comparator
    Group B

    About 20 psoriatic arthritis

    Drug: Methotrexate

  • Placebo comparator
    Group C

    About 10 healthy control group

    Drug: Placebo

Interventions

  • DrugMethotrexate

    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

    Also known as: Card14 gene(rs 34367357 )

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Psoriasis Treatment

    Assessing the Response of psoriasis and psoriatic arthritis to Methotrexate by assessment and complete cutaneous examination to evaluate the clinical type and severity of psoriasis using PASI score

    Time frame: 3 Months

07

Study locations

1 of 1 sites recruiting
  • Qina University hospital, South Valley University Hospital
    Qinā, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870500
Lead sponsor
South Valley University
Responsible party
Marwa Naguib Ahmed (Resident of Dermatology , venereology and andrology at Faculty of medicine, South Valley University) — Principal investigator
First posted
Mar 11, 2025
Start date
Mar 5, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 10, 2026 (estimated)
Last update
Mar 11, 2025

Study contacts

Marwa Naguib Ahmed, MSc
Contact
omarahmed331166@yahoo.com
+201099283315
Soheir Abdel-Hamid Ali
Contact
Soher.abdel-hamed@med.svu.edu.eg
+201066877343
Essam El-Din Abd El-Aziz Mohamed Ahmed Nada, Professor
study chair · Dermatology, Venereology and Andrology Sohag university
Eisa Mohammed Hegazy, Professor
study director · • Dermatology Venereology & Andrology Faculty of Medicine, South valley University.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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