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to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case: adults with severe psoriasis treated by adalimumab therapy. | Active Comparator |
| |
| Control: adults with severe psoriasis treated by methotrexate therapy. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab and methotrexate | Drug | Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate |
|
| 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 |
| 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 . |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shimaa f Abdelhaleem, M.B.B.Ch | Contact | 01140017278 | shaimaa_fawzy_post@medsohag.edu.eg | |
| Ramadan S Abdo Saleh, Professor | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospital | Sohag | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34372982 | Background | Rencz F, Szabo A, Brodszky V. Questionnaire Modifications and Alternative Scoring Methods of the Dermatology Life Quality Index: A Systematic Review. Value Health. 2021 Aug;24(8):1158-1171. doi: 10.1016/j.jval.2021.02.006. Epub 2021 Apr 21. | |
| 27416017 | Background | Frenzel A, Schirrmann T, Hust M. Phage display-derived human antibodies in clinical development and therapy. MAbs. 2016 Oct;8(7):1177-1194. doi: 10.1080/19420862.2016.1212149. Epub 2016 Jul 14. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2025 | |
| Reset | Jul 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2025 | Jul 30, 2025 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 6 month |
| 35276223 | Background | van der Kraaij G, Busard C, van den Reek J, Menting S, Musters A, Hutten B, de Rie M, Ouwerkerk W, van Bezooijen SJ, Prens E, Rispens T, de Vries A, de Jong E, de Kort W, Lambert J, van Doorn M, Spuls P. Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial. J Invest Dermatol. 2022 Sep;142(9):2375-2383.e6. doi: 10.1016/j.jid.2022.01.033. Epub 2022 Mar 8. |
| 28260984 | Background | Matsui T, Umetsu R, Kato Y, Hane Y, Sasaoka S, Motooka Y, Hatahira H, Abe J, Fukuda A, Naganuma M, Kinosada Y, Nakamura M. Age-related trends in injection site reaction incidence induced by the tumor necrosis factor-alpha (TNF-alpha) inhibitors etanercept and adalimumab: the Food and Drug Administration adverse event reporting system, 2004-2015. Int J Med Sci. 2017 Jan 15;14(2):102-109. doi: 10.7150/ijms.17025. eCollection 2017. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |