PsoriasiNCT05889338
Effect of Adalimumab Therapy on Psoriasis Patient
A study testing adalimumab and methotrexate in people with Psoriasi, run by Sohag University at 1 site in Egypt.
Trial summary
to evaluate the impact of adalimumab therapy on quality of life in patient with severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasi
- What is being tested?
- adalimumab and methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate.
Who cannot join
- .Pregnancy or lactation. .Chronic liver or renal disease. .History of tuberculosis. .Cancer and blood disorder.
Trial locations and contacts
1 site in 1 country.
Ramadan S Abdo Saleh, Professor contact
Egypt1 site
Sohag University Hospital
Sohag
Magdy M Amin, professor, 0100 298 0599
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasi
- Being tested
- adalimumab and methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab and methotrexateDrug
Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Case: adults with severe psoriasis treated by adalimumab therapy. | Active comparator | Not described Receives: Drug: adalimumab and methotrexate |
| Control: adults with severe psoriasis treated by methotrexate therapy. | Active comparator | Not described Receives: Drug: adalimumab and methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 month
Secondary outcomes (1)
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 .
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsoriasiStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Fawzy Abdelhalim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889338
- Sponsor's protocol ID
- Soh-Med-23-04-26MS_
- Status last verified
- Jun 2023
- First submitted
- 11 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34372982Frenzel 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.
PubMed 27416017van 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.
PubMed 35276223Matsui 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.
PubMed 28260984
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adalimumab Therapy on Quality of Life of Patients With Severe Psoriasis
- ClinicalTrials.gov ID
- NCT05889338
- Acronym / sponsor ID
- Soh-Med-23-04-26MS_
- Conditions
- Psoriasi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: adults with severe psoriasis treated by adalimumab therapy. | Active comparator | Drug: adalimumab and methotrexate |
| Control: adults with severe psoriasis treated by methotrexate therapy. | Active comparator | Drug: adalimumab and methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- .Adult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate.
Key exclusion criteria (1 listed)
- .Pregnancy or lactation. .Chronic liver or renal disease. .History of tuberculosis. .Cancer and blood disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab and methotrexateAdult patients (> 18 years) with severe psoriasis who will start treatment with either adalimumab or methotrexate | Drug | Case: adults with severe psoriasis treated by adalimumab therapy., Control: adults with severe psoriasis treated by methotrexate therapy. |
Primary outcome
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 .
1 secondary outcome
Dermatology Life Quality Index
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Background: PubMed 34372982Rencz 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.
- Background: PubMed 27416017Frenzel 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.
- Background: PubMed 35276223van 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.
- Background: PubMed 28260984Matsui 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan S Abdo Saleh, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adalimumab and methotrexate in people with Psoriasi, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shimaa f Abdelhaleem, M.B.B.Ch (01140017278, shaimaa_fawzy_post@medsohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05889338, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.