Effect of Adalimumab Therapy on Psoriasis Patient

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

Detailed Description
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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.

Official Title
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Impact of Adalimumab Therapy on Quality of Life of Patients With Severe Psoriasis

Conditions
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Psoriasi

Intervention / Treatment
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* Drug: adalimumab and methotrexate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case: adults with severe psoriasis treated by adalimumab therapy.<br> | Drug: adalimumab and methotrexate<br>* Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate<br>|
| Active Comparator: Control: adults with severe psoriasis treated by methotrexate therapy.<br> | Drug: adalimumab and methotrexate<br>* Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index | 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 . | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality Index | 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 . | 6 month |