Comparison of the efficacy of Adalimumab and Methotrexate in cases of moderate to severe of psoriasis.
Design
This is a parallel randomized controlled clinical trial that will be performed on 92 patients with moderate to sever of psoriasis. Randomization in this research is done using quadri blocks using syntax written in SPSS program. In this study outcome evaluator and data analyzer are blinded.
Settings and conduct
This study will conduct as a clinical trial study with 92 patients who will refer to Imam Hossain Hospital of Shahroud. Patients must sign an informed consent form before entering the study. In this study outcome evaluator and data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Including criteria: patients with moderate to severe psoriasis and having the satisfaction of participating in the project. Excluding criteria: history of severe burns or skin damage; existence of severe chronic hormonal disorders such as hypothyroidism; history of skin laser therapy in the past year; history of chronic liver and kidney disease and pregnancy or lactation.
Intervention groups
For patients in the intervention group, in addition to routine treatment , 80 mg of Adalimumab ampoule subcutaneously to begin and then 40 mg a week later as subcutaneously and then 40 mg subcutaneously every two weeks for 16 weeks. For patients in the control group, in addition to routine treatment (including topical 10% glycerin lotion and 25 mg hydroxyzine tablets three times daily), 20 mg of Methotrexate ampoule intramuscularly to start and then 10 mg intramuscularly one week later and then 10 mg intramuscularly will be administered every two weeks for 16 weeks.
Main outcome variables
Measurement of psoriasis severity index; Measure the percentage of surface area involved in the patient's body and Measurement of redness of psoriasis rash.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002954N26
Registration date:2022-02-28, 1400/12/09
Registration timing:prospective
Last update:2022-02-28, 1400/12/09
Update count:0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Adalimumab and Methotrexate in cases of moderate to sever of psoriasis, a double-blind clinical trial
Public title
Comparison of the effect of Adalimumab and Methotrexate in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 55-15 years;
Patients with a definite diagnosis of moderate to severe psoriasis;
Having the satisfaction of participating in the project.
Exclusion criteria:
History of severe burns or skin damage;
Existence of severe chronic hormonal disorders such as hypothyroidism;
History of severe hirsutism;
History of topical treatment of psoriasis with drugs and combined solutions in the last six months;
History of skin laser in the past year;
History of chronic liver and kidney disease;
History of hormone therapy (estrogen or testosterone),
Pregnancy or lactation,
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated to intervention and control groups according to random allocation table that illustrated by a statistician. Randomization was done using permuted block randomization method (Block size was 4) using blocked random allocation syntax in SPSS software. For calculation sample
size was 92 and number of blocks was 23. Allocation concealment was done using closed opaque envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study outcome evaluator and data analyzer are blinded. The division of patients into two groups intervention and control, review and record treatment results is done by a qualified nurse who has no knowledge of the actions performed in the two groups. Data analysis will also be performed by a project epidemiologist who has no knowledge of patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences; 7 Tir squer, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.SHMU.REC.1400.239
Health conditions studied
1
Description of health condition studied
Moderate to sever of psoriasis
ICD-10 code
L40.1
ICD-10 code description
Generalized pustular psoriasis
Primary outcomes
1
Description
Measurement of psoriasis severity index
Timepoint
Beginning and end of the study
Method of measurement
Psoriasis Severity Index Calculator Software Version 1.7.2
2
Description
Measure the percentage of surface area involved in the patient's body
Timepoint
Beginning and end of the study
Method of measurement
Calculated with the formula of the percentage of surface area involved in the patient's body
3
Description
Measurement of redness of psoriasis rash
Timepoint
Beginning and end of the study
Method of measurement
Observation and clinical examination
Secondary outcomes
1
Description
Measurement of the rash protrusion of psoriasis
Timepoint
Beginning and end of the study
Method of measurement
Observation and clinical examination
2
Description
Measuring the extent of scaling of the psoriasis rash
Timepoint
Beginning and end of the study
Method of measurement
Observation and clinical examination
Intervention groups
1
Description
Intervention group: For patients in the intervention group, in addition to routine treatment (including the use of glycerin topical lotion 10% and 25 mg hydroxyzine tablets three times a day), 80 mg of Adalimumab ampoule subcutaneously to begin and then 40 mg a week later as subcutaneously and then 40 mg subcutaneously every two weeks for 16 weeks.
Category
Treatment - Drugs
2
Description
Control group: For patients in the control group, in addition to routine treatment (including topical 10% glycerin lotion and 25 mg hydroxyzine tablets three times daily), 20 mg of Methotrexate ampoule intramuscularly to start and then 10 mg intramuscularly one week later and then 10 mg intramuscularly will be administered every two weeks for 16 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital of Shahroud
Full name of responsible person
Dr. Marjan Talebi
Street address
Imam Hossein Hospital., End Imam street., Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
marjan.talebi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hasan Emamian
Street address
Vice chancellor for research; Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Province
Semnan
Postal code
3616647555
Phone
+98 23 3239 4499
Fax
+98 23 3239 4800
Email
pajouhesh@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research; Shahroud University medical and Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Fateme Torabi
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
ftrb4524@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Marjan Talebi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Hossein hospital., End Imam street., Shahroud., Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
marjan.talebi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Imam Hossein Hospital, End Imam street, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
mb.sohrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available