Effect of Adalimumab Therapy on Psoriasis Patient
Primary Purpose
Psoriasi
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
adalimumab and methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasi
Eligibility Criteria
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.
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Case: adults with severe psoriasis treated by adalimumab therapy.
Control: adults with severe psoriasis treated by methotrexate therapy.
Arm Description
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05889338
Brief Title
Effect of Adalimumab Therapy on Psoriasis Patient
Official Title
Impact of Adalimumab Therapy on Quality of Life of Patients With Severe Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case: adults with severe psoriasis treated by adalimumab therapy.
Arm Type
Active Comparator
Arm Title
Control: adults with severe psoriasis treated by methotrexate therapy.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
adalimumab and methotrexate
Intervention Description
Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index
Description
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 .
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Description
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 .
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa f Abdelhaleem, M.B.B.Ch
Phone
01140017278
Email
shaimaa_fawzy_post@medsohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ramadan S Abdo Saleh, Professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor
Phone
0100 298 0599
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34372982
Citation
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.
Results Reference
background
PubMed Identifier
27416017
Citation
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.
Results Reference
background
PubMed Identifier
35276223
Citation
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.
Results Reference
background
PubMed Identifier
28260984
Citation
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.
Results Reference
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Effect of Adalimumab Therapy on Psoriasis Patient
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