The aim of this study was to evaluate the effect of adalimumab in patients with refractory psoriasis
Design
Randomized clinical trial with control group, with parallel groups, without blinding, , phase 3 on 60 patients. Even and odd numbers were used for randomization.
Settings and conduct
This study was performed in Sina Hospital, Tabriz, dermatology ward, and there is no blinding. Patients in the intervention and control groups will be randomly evaluated using even and odd numbers.
Participants/Inclusion and exclusion criteria
Patients with confirmed psoriasis, non-response to previous treatments, no use of herbal medicines, and resistance to at least one systemic drug are included in the study. Patients with hypersensitivity to adalimumab and other underlying organ disorders are excluded from the study.
Intervention groups
Intervention group: At the beginning of the study, they will receive 80 mg of adalimumab. The next dose will be one week later (40 mg) and then every two weeks (40 mg) (the total duration of treatment will be two months).
Control group: will receive routine psoriasis treatment including methotrexate and cyclosporine at a specific dose determined by a dermatologist (project manager).
Main outcome variables
Disease severity, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120524009844N8
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Mehdi Amirnia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
amirniam@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-11-20, 1399/08/30
Scientific title
Therapeutic Effects of Adalimumab in Patients with Resistant Psoriasis Patients by DLQ and PASI Questionnaires
Public title
Therapeutic Effects of Adalimumab in Patients with Resistant Psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed pseuriasis
Accepted
Patients without responce to previous treatments
Don’t use of other drugs and herbal supplments
Resistance to atleast one systemic treatment
Exclusion criteria:
Allergy to Adalimumab
Having active inflammation such as tuberculosis, malignancies and etc
Neurological disorders
Hematological disorders
Moderate to severe heart failure
Pregnant and breast feeding woman
Mental retared patients
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using even and odd numbers. The intervention group will be odd numbers and the control group will be even numbers. The number zero will be considered as an even.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Third floor, Central Building 2 , Tabriz Medical Sciences University, Gholgasht ave , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2020-08-10, 1399/05/20
Ethics committee reference number
IR.TBZMED.REC.1399.537
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Disease severity
Timepoint
At the beginning of the study, 1, 2, 3 and 4 months after receiving the intervention
Method of measurement
Psoriasis Area Severity Index Score
2
Description
Quality of life
Timepoint
Initiation of the study, 4 months after receiving the intervention
Method of measurement
Dermatologic Quality of Life Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the beginning of the study, they will receive 80 mg of adalimumab. The next dose will be one week later (40 mg) and then every two weeks (40 mg) (the total duration of treatment will be two months).
Category
Treatment - Drugs
2
Description
Control group: Will receive routine psoriasis treatment including methotrexate and cyclosporine at a specific dose determined by a dermatologist (project manager).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mehdi Amirnia
Street address
Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
516369888
Phone
+98 41 3549 8236
Fax
+98 41 3549 8406
Email
mehamir46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Samiei
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Central Building of Medical Sciences, Daneshgah Square.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3329 9654
Fax
+98 41 3329 9654
Email
samieim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Amirnia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1540 6612
Fax
+98 41 1540 6612
Email
amirniam@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.