Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients

NCT06370156 | Not Yet Recruiting DMC

• 1 other identifier: TWEAK in plaque psoriasis
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality. Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future. To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Treatment of psoriasis vulgaris and psoriatic arthritis

  to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.

  1 year

Secondary Outcomes (1)

• Evaluation of serum TWEAK

  1 year

Study Arms (3)

Group A : (Adalimumab therapy)

About 30 patients suffering from Plaque Psoriasis and will take Adalimumab therapy orally. Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post Adalimumab therapy

Drug: Adalimumab

Group B : (methotrexate therapy)

About 30 patients suffering from Psoriatic arthritis and will take methotrexate therapy orally. Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post methotrexate therapy

Drug: Adalimumab

Group C: (control Group):

About 40 healthy individuals selected as control group as related to age, sex ,BMI matching with healthy individuals

Drug: Adalimumab

Interventions

Adalimumab DRUG

To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.

Also known as: Methotrexate

Group A : (Adalimumab therapy); Group B : (methotrexate therapy); Group C: (control Group):

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* TWEAK serum level assessment: blood sample (about 5cc) from the antecubital vessel of well-being control candidates and psoriatic candidates before and after MTX and Adalimumab therapy. * Lipid profile will be calculated for patients treated, Liver \& renal function will be measured and HCV, HBV and TB .

You may qualify if:

• Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
• Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs

You may not qualify if:

• Previously received biologic immunomodulating agents, except for those targeting TNF
• Previously been treated with three or more different TNF inhibitors
• Active, ongoing inflammatory diseases other than PsA
• Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
• A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
• History of ongoing, chronic or recurrent infections, or evidence of active TB infection
• History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)
• Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation
• Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

South Valley Hospitals

Qina, Egypt

Location

MeSH Terms

Interventions

Adalimumab; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Eisa Mohamed Hegazy, Professor

CONTACT

+201094337795; eisa_mohamed4152@med.svu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 10, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

EG (1)