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Effect of Adalimumab Therapy on Psoriasis Patient

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05889338
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sohag University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasi
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Case: adults with severe psoriasis treated by adalimumab therapy.

Active Comparator: Control: adults with severe psoriasis treated by methotrexate therapy.

Interventions

Drug: - adalimumab and methotrexate

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

Contact a Trial Team

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International Sites

Sohag University Hospital, Sohag, Egypt

Status

Address

Sohag University Hospital

Sohag, ,

Site Contact

Magdy M Amin, professor

shaimaa_fawzy_post@medsohag.edu.eg

0100 298 0599

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