Effect of Adalimumab Therapy on Psoriasis Patient

June 1, 2023 updated by: Shimaa Fawzy Abdelhalim, Sohag University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ramadan S Abdo Saleh, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor
          • Phone Number: 0100 298 0599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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.
Drug: adalimumab and methotrexate
Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
Active Comparator: Control: adults with severe psoriasis treated by methotrexate therapy.
Drug: adalimumab and methotrexate
Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index
Time Frame: 6 month
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
Time Frame: 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-26MS_

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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