Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2023-06-30
2024-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Case: adults with severe psoriasis treated by adalimumab therapy.
adalimumab and methotrexate
Adult patients (\> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
Control: adults with severe psoriasis treated by methotrexate therapy.
adalimumab and methotrexate
Adult patients (\> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
Interventions
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adalimumab and methotrexate
Adult patients (\> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Shimaa Fawzy Abdelhalim
Dermatology resident at Gehina Hospital
Locations
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Sohag University Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Ramadan S Abdo Saleh, Professor
Role: CONTACT
Facility Contacts
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Magdy M Amin, professor
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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Soh-Med-23-04-26MS_
Identifier Type: -
Identifier Source: org_study_id
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