NCT06870500

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

March 6, 2025

Last Update Submit

March 10, 2025

Conditions

Psoriatic Arthritis

Outcome Measures

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

    3 Months

Study Arms (3)

Group A

ACTIVE COMPARATOR

About 20 patients with psoriasis

Drug: Methotrexate

Group B

ACTIVE COMPARATOR

About 20 psoriatic arthritis

Drug: Methotrexate

Group C

PLACEBO COMPARATOR

About 10 healthy control group

Drug: Placebo

Interventions

MethotrexateDRUG

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 )
Group AGroup B
PlaceboDRUG

Placebo

Group C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qina University hospital, South Valley University Hospital

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

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

    Dermatology, Venereology and Andrology Sohag university

    STUDY CHAIR

  • Eisa Mohammed Hegazy, Professor

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

    STUDY DIRECTOR

Central Study Contacts

Marwa Naguib Ahmed, MSc

CONTACT

+201099283315omarahmed331166@yahoo.com

Soheir Abdel-Hamid Ali

CONTACT

+201066877343Soher.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 at Faculty of medicine

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

March 5, 2025

Primary Completion

March 1, 2026

Study Completion

March 10, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

EG(1)