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Clinical Trials/NCT06870500
NCT06870500RecruitingNot Applicable

Card14gene (rs34367357 ) Polymorphism in Egyptian Psoriatic and Psoriatic Arthritis Patient and Its Relation With Response to Methotrexate

South Valley University1 site in 1 country50 target enrollmentStarted: March 5, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Psoriasis Treatment

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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

  • 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.

Arms & Interventions

Group B

Active Comparator

About 20 psoriatic arthritis

Intervention: Methotrexate (Drug)

Group C

Placebo Comparator

About 10 healthy control group

Intervention: Placebo (Drug)

Group A

Active Comparator

About 20 patients with psoriasis

Intervention: Methotrexate (Drug)

Outcomes

Primary Outcomes

Psoriasis Treatment

Time Frame: 3 Months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marwa Naguib Ahmed

Resident of Dermatology , venereology and andrology at Faculty of medicine

South Valley University

Study Sites (1)

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