Plaque PsoriasisNCT06370156
Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients
An observational study of Plaque Psoriasis, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality. Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Adalimumab
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 10 Jun 2025
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * TWEAK serum level assessment: blood sample (about 5cc) from the antecubital vessel of well-being control candidates and psoriatic candidates before and after MTX and Adalimumab therapy. * Lipid profile will be calculated for patients treated, Liver \& renal function will be measured and HCV, HBV and TB .
Who may be able to join
- Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
- Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs
Who cannot join
- Previously received biologic immunomodulating agents, except for those targeting TNF
- Previously been treated with three or more different TNF inhibitors
- Active, ongoing inflammatory diseases other than PsA
- Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
- A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
- History of ongoing, chronic or recurrent infections, or evidence of active TB infection
Show all 9Show fewer
- History of malignancy within the past 5 years (except for basal cell carcinoma or actinic keratosis that has been treated with no evidence of recurrence in the past 3 months, in situ cervical cancer or non-invasive malignant colon polyps that had been removed)
- Underlying metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious or gastrointestinal conditions which, in the opinion of the investigator, immunocomprimised the patient and/or placed the patient at unacceptable risk for participation
- Pregnant or nursing (lactating) women and women of child-bearing potential unwilling to use effective contraception during the study and for 16 weeks after stopping treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Valley Hospitals
Qina
Eisa Mohamed Hegazy, Professor, +201094337795, eisa_mohamed4152@med.svu.edu.eg
About this study
Official title: Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.
To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required
Read the detailed description
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
The cytokine tumor necrosis factor (TNF)-related weak inducer of apoptosis (TWEAK), in cooperation with its sole receptor, Fn14, is involved in miscellaneous biological and pathological processes .
The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines. The upregulation of TWEAK and Fn14 occurs in many human skin disorders, including cutaneous lupus erythematosus, bullous pemphigoid, and dermatomyositis . There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis.
The introduction of anti-tumor necrosis factor-α inhibitors (anti-TNF agents) has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents.
Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks, according to recent findings.
Methotrexate (MTX)was approved for the treatment of psoriasis by the US Food and Drug Administration (FDA). At present, the drug is indicated for the treatment of practically all forms of moderate or severe psoriasis, including psoriatic arthritis .
- Conditions
- Plaque Psoriasis
- Being tested
- Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Methotrexate
To suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Group A : (Adalimumab therapy) | About 30 patients suffering from Plaque Psoriasis and will take Adalimumab therapy orally.
Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post Adalimumab therapy Receives: Drug: Adalimumab | |
| Group B : (methotrexate therapy) | About 30 patients suffering from Psoriatic arthritis and will take methotrexate therapy orally.
Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post methotrexate therapy Receives: Drug: Adalimumab | |
| Group C: (control Group): | About 40 healthy individuals selected as control group as related to age, sex ,BMI matching with healthy individuals Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of psoriasis vulgaris and psoriatic arthritis
to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.
Measured: 1 year
Secondary outcomes (1)
Evaluation of serum TWEAK
To detect the correlation between serum TWEAK the PASI score and the ACR score pre and post Methotrexate and Adalimumab therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion10 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370156
- Sponsor's protocol ID
- TWEAK in plaque psoriasis
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients Treated With Adalimumab and Methotrexate: Case Control Study
- ClinicalTrials.gov ID
- NCT06370156
- Acronym / sponsor ID
- TWEAK in plaque psoriasis
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 10 Jun 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.
To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required
Detailed description
Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.
The cytokine tumor necrosis factor (TNF)-related weak inducer of apoptosis (TWEAK), in cooperation with its sole receptor, Fn14, is involved in miscellaneous biological and pathological processes .
The main role of TWEAK is in the induction of pro-inflammatory cytokines and chemokines. The upregulation of TWEAK and Fn14 occurs in many human skin disorders, including cutaneous lupus erythematosus, bullous pemphigoid, and dermatomyositis . There is a lack of studies examining the role of TWEAK in patients with psoriasis or psoriatic arthritis.
The introduction of anti-tumor necrosis factor-α inhibitors (anti-TNF agents) has significantly improved outcomes among patients with PsA but a proportion of patients have an inadequate response or poor tolerability to these agents.
Adalimumab treatment continuation in routine clinical practice may lead to benefits for remission and low disease activity among patients with psoriasis, psoriatic arthritis, or axial spondyloarthritis who did not achieve their treatment goals at 12 weeks, according to recent findings.
Methotrexate (MTX)was approved for the treatment of psoriasis by the US Food and Drug Administration (FDA). At present, the drug is indicated for the treatment of practically all forms of moderate or severe psoriasis, including psoriatic arthritis .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A : (Adalimumab therapy) | – | Drug: AdalimumabAbout 30 patients suffering from Plaque Psoriasis and will take Adalimumab therapy orally. Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post Adalimumab therapy |
| Group B : (methotrexate therapy) | – | Drug: AdalimumabAbout 30 patients suffering from Psoriatic arthritis and will take methotrexate therapy orally. Correlation between serum\& TWEAK levels and Psoriasis Area and Severity Index (PASI) score and the ACR score pre and post methotrexate therapy |
| Group C: (control Group): | – | Drug: AdalimumabAbout 40 healthy individuals selected as control group as related to age, sex ,BMI matching with healthy individuals |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * TWEAK serum level assessment: blood sample (about 5cc) from the antecubital vessel of well-being control candidates and psoriatic candidates before and after MTX and Adalimumab therapy. * Lipid profile will be calculated for patients treated, Liver \& renal function will be measured and HCV, HBV and TB .
Key inclusion criteria (2 listed)
- Patients of both sexes with psoriasis vulgaris and Psoriatic arthritis.
- Active PsA with three or more tender and swollen joints and met the CASPAR, despite previous treatment with NSAIDs, DMARDs or anti-TNFs
Key exclusion criteria (9 listed)
- Previously received biologic immunomodulating agents, except for those targeting TNF
- Previously been treated with three or more different TNF inhibitors
- Active, ongoing inflammatory diseases other than PsA
- Active TB (patients with latent TB had to commence treatment for latent TB before study entry)
- A history of hepatitis B or C, human immunodeficiency virus, or any active systemic infection within the 2 weeks before baseline
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 |
|---|---|---|
| AdalimumabAlso: MethotrexateTo suggests the role of TWEAK and the effectiveness of different treatments like adalimumab and methotrexate in managing plaque psoriasis and psoriatic arthritis. | Drug | Group A : (Adalimumab therapy), Group B : (methotrexate therapy), Group C: (control Group): |
Primary outcome
Treatment of psoriasis vulgaris and psoriatic arthritis
Time frame: 1 year
to see the efficacy of drug study in improving the prognosis of patients with psoriasis vulgaris and psoriatic arthritis.
1 secondary outcome
Evaluation of serum TWEAK
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Egymedicalpedia 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 2 inclusion and 9 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 17 Apr 2024. 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 Eisa Mohamed Hegazy, Professor (+201094337795, eisa_mohamed4152@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of psoriasis vulgaris and psoriatic arthritis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.