One of the drug treatments for psoriasis is anti TNF-a treatment.TNF particularly the alpha subtype is a cytokine which is produced by immune system in inflammatory disorders.This drug can lead to increase in leptin and therefore lead to increase in BMI(body mass index). This issue may affect the results of the treatment, since weight increase leads to increase in severity of psoriasis. The inclusion criteria consisted of psoriatic patients candidate for treatment with anti TNFa inhibitors and no contradiction for infliximab treatment, exclusion criteria consisted of pregnant women; breastfeeding women and concomitant use of systemic retinoid. This study is a clinical trial of before-after type studies.The sample of study are psoriatic patients who are candidates for receiving infliximab infusion. the sample size is 22. The infusion will be performed intravenously in 5mg/kg dose, at the beginning of the study and after 2,6 and 8 weeks and after that every 8 week until week twenty-four.In each infusion height, weight, BMI, LBM and severity of the disease based on PASI score will be measured and levels of cholesterol and triglyceride and leptin will be measured at the beginning and the end of the treatment.the effect of the treatment on these variables will be assessed,to evaluate weather increase in BMI with this drug leads to poor outcome in this therapy or not.
General information
Acronym
BMI,LBM
IRCT registration information
IRCT registration number:IRCT2013082912065N1
Registration date:2013-08-29, 1392/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-29, 1392/06/07
Registrant information
Name
Arghavan Azizpour
Name of organization / entity
Razi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0668
Email address
a-azizpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science, Razi Hospital
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infliximab on lean body mass and body mass index in psoriasis patients
Public title
The effect of infliximab on precentage of body fat and weight in psoriasis patients
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria :
patients with psoriasis; candidate for treatment with infliximab; having consent from the patient to participate in the study; no contradiction for infliximab treatment
exclusion criteria :
not being able to follow up the patient; pregnant women; breastfeeding women; concomitant use of other cytotoxic drugs; Severe complications leading to treatment discontinuation; concomitant use of systemic retinoid
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Tehran University of Medical Sciences
Street address
Ghods avenue,
City
Tehran
Postal code
Approval date
2012-11-08, 1391/08/18
Ethics committee reference number
91/د/130/1923
Health conditions studied
1
Description of health condition studied
psoriasis
ICD-10 code
L40
ICD-10 code description
psoriasis
Primary outcomes
1
Description
body mass index
Timepoint
before initiation of the study,week 6,12, and 24 after the last dose
Method of measurement
weight with kilograms on a scale,height with meters with the use of a rubber meter
2
Description
lean body mass
Timepoint
before initiation of the study,week 6,12, and 24 after the last dose
Method of measurement
weight with kilograms on a scale,height with meters with the use of a rubber meter
Secondary outcomes
1
Description
leptin
Timepoint
before initiation and after the last dose
Method of measurement
lab
2
Description
cholestrol
Timepoint
before initiation and after the last dose
Method of measurement
lab
3
Description
trigliseride
Timepoint
before initiation and after the last dose
Method of measurement
lab
Intervention groups
1
Description
g infliximab infusion.the infusion will be performed intravenously in 5mg/kg dose, at the beginning of the study and after 2,6 and 8 weeks and after that every 8 week until week twenty-four
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Arghavan Azizppour
Street address
Vahdateslami avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science,Razi Hospital
Full name of responsible person
Dr AmirHoushang Ehsani
Street address
Vahdateslami avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science,Razi Hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Arghavan Azizpour
Position
resident
Other areas of specialty/work
Street address
Vahdateslami avenue
City
Tehran
Postal code
Phone
+98 21 5563 0668
Fax
Email
www.tums.ac.ir/raz
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Arghavan Azizpour
Position
resident
Other areas of specialty/work
Street address
Vahdateslami avenue
City
Tehran
Postal code
Phone
+98 21 5563 0668
Fax
Email
a63a@yahoo.com a-azizpour@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi hospital
Full name of responsible person
Arghavan Azizpour
Position
resident
Other areas of specialty/work
Street address
Vahdateslami avenue
City
Tehran
Postal code
Phone
+98 21 5563 0668
Fax
Email
a63a@yahoo.com a-azizpour@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)