Genetic Variation in TRAF3IP2 (rs13190932)

NCT07086924 | Recruiting DMC

• 1 other identifier: Genetic variation in TRAF3IP2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis is an immune-mediated inflammatory disease that is highly prevalent worldwide, affecting approximately 2-3% of the world population. It is characterized by red, scaly plaques that can appear on various parts of the body, causing significant physical and psychological burden to affected individuals. The Pathogenesis of PsA involves a complex interplay of genetic, immunological, and environmental factors.Genetic studies have identified several susceptibility loci, including HLA-Cw6 and IL23R, which are shared with psoriasis. Additionally, the presence of certain alleles, such as HLA-B27, is associated with a more severe disease course and a higher likelihood of axial involvement.

Conditions

Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

• Treatment of Psoriasis and Psoriatic arthritis

  Treatment the patients whom suffering from Psoriasis and Psoriatic arthritis and Assessment of clinical improvement to methotrexate therapy according to: PASI score into PASI 50: means 50% reduction in PASI score - an acceptable measure of efficacy for secondary endpoints in psoriasis clinical trials PASI 75: means 75% reduction in PASI score - standard efficacy measure used in most psoriasis clinical studies1 PASI 90: means 90% reduction in PASI score (almost clear skin) PASI 100: means Completely clear skin.

  3 months

• Evalaute the effect of treatment with Methotrexate

  Evaluate the effect of treatment with methotrexate therapy (15 mg per week) on the level of serum TRAF3IP2( rs13190932 ) gene Polymorphism on the Participants whom suffering from Psoriasis and Psoriatic arthritis.

  3 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

About 30 patients suffering from psoriasis

Drug: Methotrexate

Group B

ACTIVE COMPARATOR

About 10 patients suffering from psoriatic arthritis

Drug: Methotrexate

Group C

EXPERIMENTAL

About 10 healthy control group

Drug: Methotrexate

Interventions

Methotrexate DRUG

Assessing the response of psoriasis and psoriatic arthritis to Methotrexate. and also Assessing the pharmacogenetic association between TRAF3IP2 ( rs13190932 ) gene Polymorphism in psoriatic and psoriatic arthritis patients taking Methotrexate.

Also known as: Genetic variation in TRAF3IP2

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 -70years .
• the severity of cutaneous affection is categorized according to PASI score into PASI 7-12 (moderate severity), and PASI \> 12 (severe severity). (15)Confirmed diagnosis: Psoriasis vulgaris (PsV) or psoriatic arthritis (PsA) diagnosed by the Dermatologist or the Rheumatologist.
• Willingness to participate: Signed informed consent.
• Initiating methotrexate (MTX) therapy: For prospective cohort.
• Availability for follow-up: Patients must be willing and able to attend scheduled visit.

You may not qualify if:

• 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.
• Previous genetic analysis Patients who have previously undergone genetic analysis for the TRAF3IP2 gene polymorphism (rs13190932).

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena Hospital

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Methotrexate; Genetic Variation; Coat Protein Complex I

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Genetic Phenomena; Vesicular Transport Proteins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Eisa Mohammed Hegazy, Professor

  Dermatology,Venereology,and Andrology Department,Faculty of Medicine,South Valley University, Egypt

  STUDY CHAIR

Central Study Contacts

Fawzia Mohamed Abd Elzaher, MSC

CONTACT

+201001238064; drfawzia11111995@gmail.com

Soheir Abdel-Hamid Ali, Lecturer

CONTACT

+201066877343; Soher.abdel-hamed@med.svu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Dermatology, Venereology and Andrology,Faculty of Medicine

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-06

Locations

EG (1)