PsoriasisPhase 4NCT03904680
Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
A Phase 4 study testing Methotrexate and Vitamin D in people with Psoriasis, run by Cairo University.
Trial summary
The prevalence of cardiovascular risk in psoriasis has been reported in previous studies.Various studies have also shown that systemic treatments for psoriasis, including methotrexate, may significantly decrease this cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate and Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Nov 2019
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Psoriasis patient not on systemic treatment at least for 3 months before inclusion in the study
- PASI >10
Who cannot join
- Patients with autoimmune diseases.
- Patients with liver disease or kidney diseases
- Patients with Diabetes mellitus
- Females in child bearing period not using methods of contraception
- Any associated dermatological disease
- Evidence of infection
- Pregnancy and lactation
- Patients taking vitamin D
Trial locations and contacts
No sites are listed yet.
Mohamed HM El-Komy, MD contact
About this study
The prevalence of cardiovascular risk in psoriasis has been reported in previous studies.Various studies have also shown that systemic treatments for psoriasis, including methotrexate, may significantly decrease this cardiovascular risk. We proposed that the addition of vitamin D may not only improve the therapeutic effect of various treatment modalities but also increase its effect on decreasing the cardiovascular risk in psoriasis. So our aim of work is to assess the Clinical improvement and cardiovascular risks in psoriatic patients after treatment with methotrexate alone with the dose of 0.2-0.5 mg/kg/week for three months in comparison to combined methotrexate with the same dose and vitamin D injection with the dose of 200,000 IU per month for 3 months.
Each patient will do the following before starting treatment\& after 3 months:
- Fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin
- Liver and Kidney function tests.
- Cardiovascular risk assessment by measuring the intima media thickness of carotid arteries using Carotid duplex and High sensitive C reactive protein measuring by particle-enhanced immunonephelometry on autoanalyzer.
- Lipid profile (HDL, LDL, cholesterol and triglycerides).
- Calculate body mass index and measure blood pressure
- Albumin /creatinine ratio
- Serum vitamin D level. Clinical response will be evaluated by Psoriasis Area and Severity index (PASI) \& Psoriasis Disability Index (PDI) scores before and after 3 months of treatment
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Vitamin D
- Keywords
- Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate 2.5 mg tablet
Vitamin DDrug
Vitamin D 200,000 IU ampules
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | 15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months. Receives: Drug: Methotrexate |
| Methotrexate and Vitamin D | Active comparator | 15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week and Vitamin D intramuscular injections with the dose of 200,000 IU per month for 3 months. Receives: Drug: Methotrexate; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intima Media thickness of carotid arteries from baseline
Intima Media thickness of left and right common carotid arteries, bulb of common carotid arteries and internal carotid arteries as measured by carotid duplex before starting the treatment and after 3 months of treatment.
Measured: Baseline and 12 weeks
Change in high sensitive C- Reactive protein from baseline
Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline.
Measured: Baseline and 12 weeks
Psoriasis Area and Severity index change (PASI)
Change in PASI after 3 months of treatment from baseline
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly divided into 2 groups: Group A: 15 patients will take methotrexate weekly for 3 months for the treatment of psoriasis. Group B: will take methotrexate weekly in addition to Vitamin D injections monthly for 3 months for treatment of psoriasis
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Raafat Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904680
- Sponsor's protocol ID
- Psoriasis
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Furue M, Tsuji G, Chiba T, Kadono T. Cardiovascular and Metabolic Diseases Comorbid with Psoriasis: Beyond the Skin. Intern Med. 2017;56(13):1613-1619. doi: 10.2169/internalmedicine.56.8209. Epub 2017 Jul 1.
PubMed 28674347Fu LW, Vender R. Systemic role for vitamin d in the treatment of psoriasis and metabolic syndrome. Dermatol Res Pract. 2011;2011:276079. doi: 10.1155/2011/276079. Epub 2011 Jun 5.
PubMed 21747838Manolis AA, Manolis TA, Melita H, Manolis AS. Psoriasis and cardiovascular disease: the elusive link. Int Rev Immunol. 2019;38(1):33-54. doi: 10.1080/08830185.2018.1539084. Epub 2018 Nov 20.
PubMed 30457023
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Effect of Methotrexate Alone Versus Methotrexate and Vitamin D on the Cardiovascular Risk of Psoriatic Patients
- ClinicalTrials.gov ID
- NCT03904680
- Acronym / sponsor ID
- Psoriasis
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Cardiovascular risk, Methotrexate, Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Apr 2019 (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.
The prevalence of cardiovascular risk in psoriasis has been reported in previous studies.Various studies have also shown that systemic treatments for psoriasis, including methotrexate, may significantly decrease this cardiovascular risk. We proposed that the addition of vitamin D may not only improve the therapeutic effect of various treatment modalities but also increase its effect on decreasing the cardiovascular risk in psoriasis. So our aim of work is to assess the Clinical improvement and cardiovascular risks in psoriatic patients after treatment with methotrexate alone with the dose of 0.2-0.5 mg/kg/week for three months in comparison to combined methotrexate with the same dose and vitamin D injection with the dose of 200,000 IU per month for 3 months.
Each patient will do the following before starting treatment\& after 3 months:
- Fasting blood sugar, 2 hours postprandial and glycosylated hemoglobin
- Liver and Kidney function tests.
- Cardiovascular risk assessment by measuring the intima media thickness of carotid arteries using Carotid duplex and High sensitive C reactive protein measuring by particle-enhanced immunonephelometry on autoanalyzer.
- Lipid profile (HDL, LDL, cholesterol and triglycerides).
- Calculate body mass index and measure blood pressure
- Albumin /creatinine ratio
- Serum vitamin D level. Clinical response will be evaluated by Psoriasis Area and Severity index (PASI) \& Psoriasis Disability Index (PDI) scores before and after 3 months of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomly divided into 2 groups: Group A: 15 patients will take methotrexate weekly for 3 months for the treatment of psoriasis. Group B: will take methotrexate weekly in addition to Vitamin D injections monthly for 3 months for treatment of psoriasis
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: Methotrexate15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week for 3 months. |
| Methotrexate and Vitamin D | Active comparator | Drug: Methotrexate, Drug: Vitamin D15 patients will take methotrexate weekly with the dose of 0.2-0.5 mg/kg/week and Vitamin D intramuscular injections with the dose of 200,000 IU per month for 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Psoriasis patient not on systemic treatment at least for 3 months before inclusion in the study
- PASI >10
Key exclusion criteria (8 listed)
- Patients with autoimmune diseases.
- Patients with liver disease or kidney diseases
- Patients with Diabetes mellitus
- Females in child bearing period not using methods of contraception
- Any associated dermatological disease
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 |
|---|---|---|
| MethotrexateMethotrexate 2.5 mg tablet | Drug | Methotrexate, Methotrexate and Vitamin D |
| Vitamin DVitamin D 200,000 IU ampules | Drug | Methotrexate and Vitamin D |
Primary outcome
Change in Intima Media thickness of carotid arteries from baseline
Time frame: Baseline and 12 weeks
Intima Media thickness of left and right common carotid arteries, bulb of common carotid arteries and internal carotid arteries as measured by carotid duplex before starting the treatment and after 3 months of treatment.
Change in high sensitive C- Reactive protein from baseline
Time frame: Baseline and 12 weeks
Change in high sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation, after 3 months of treatment from baseline.
Psoriasis Area and Severity index change (PASI)
Time frame: Baseline and 12 weeks
Change in PASI after 3 months of treatment from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 28674347Furue M, Tsuji G, Chiba T, Kadono T. Cardiovascular and Metabolic Diseases Comorbid with Psoriasis: Beyond the Skin. Intern Med. 2017;56(13):1613-1619. doi: 10.2169/internalmedicine.56.8209. Epub 2017 Jul 1.
- Background: PubMed 21747838Fu LW, Vender R. Systemic role for vitamin d in the treatment of psoriasis and metabolic syndrome. Dermatol Res Pract. 2011;2011:276079. doi: 10.1155/2011/276079. Epub 2011 Jun 5.
- Background: PubMed 30457023Manolis AA, Manolis TA, Melita H, Manolis AS. Psoriasis and cardiovascular disease: the elusive link. Int Rev Immunol. 2019;38(1):33-54. doi: 10.1080/08830185.2018.1539084. Epub 2018 Nov 20.
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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.
Mohamed HM El-Komy, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Vitamin D in people with Psoriasis, run by Cairo University.
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 8 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 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eman R Said, MD (+201110066044, dremy07@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intima Media thickness of carotid arteries from baseline (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 NCT03904680, which also lists 3 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 Apr 2019.