Effect of Adalimumab Therapy on Psoriasis Patient

Sohag University

Status: Not yet enrolling

Conditions: Psoriasi

Treatments: Drug: adalimumab and methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT05889338

Soh-Med-23-04-26MS_

Details and patient eligibility

About

to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis.

Full description

to evaluate the impact of adalimumab therapy against methotrexate therapy on quality of life in patient with severe psoriasis and follow up after 24 week by A- Medical history age, sex, marital state, occupation, educational level and family history. dermatologic history: onset, course, duration. B- Complete dermatologic examination

C- Psoriasis Area and Severity Index (PASI) score:

The scoring involves rating the symptoms of psoriasis from none to very severe and estimating the percentage of the body that they affect.The range of absolute PASI scores is 0-72, with higher scores indicating a greater severity of psoriasis. A score of 0 indicates no psoriasis, while a score higher than 10 suggests severe psoriasis. The scoring system includes a section for intensity and another for body coverage .The score will be evaluated before treatment, at week 12 and at week 24.

D- Dermatology Life Quality Index (DLQI):

It is self-reported questionnaire . It has been translated to >110 languages. Measurement properties of the DLQI, such as validity, reliability, and responsiveness to change were reported. It is widely used in both clinical practice and research settings, including randomized controlled trials, patient registries, and national treatment and reimbursement guidelines . The study will depend on the Arabic Tunisian version of the DLQI questionnaire . DLQI consists of 10 questions related to symptoms, feelings, daily activities, leisure, work, personal relationships and the effects of treatment on daily life within the past week. Scores can range from 0 to 30, with higher scores representing worse quality of life . The questionnaire will be answered by all participant before initiation of treatment, at week 12 and at week 24 of treatment.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

.Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate.

Exclusion criteria

.Pregnancy or lactation. .Chronic liver or renal disease. .History of tuberculosis. .Cancer and blood disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Case: adults with severe psoriasis treated by adalimumab therapy.

Active Comparator group

Treatment:

Drug: adalimumab and methotrexate

Control: adults with severe psoriasis treated by methotrexate therapy.

Active Comparator group

Treatment:

Drug: adalimumab and methotrexate