The goal of this study is evaluation of oral Atorvastatin and Simvastatin effect on rheumatoid arthritis disease activity ((DAS28 score). Population study will be rheumatoid arthritis patients referred to the Rheumatology Clinic of Alzahra Hospital. Sample size in this study is 150. This study is a randomized double blind controlled trial that will start at the spring 2010 and will continue to spring 2011. The primary endpoint is improvement of clinical symptoms and laboratory parameters of patients following oral consumption of Simvastatin or Atorvastatin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811161778N2
Registration date:2010-04-06, 1389/01/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-04-06, 1389/01/17
Registrant information
Name
Mansour Salesi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1265 1983
Email address
salesi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of statin effect on the disease activity in rheumatoid arthritis
Public title
Statins and rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients (proved by ACR criteria) and 3 months passed from their diagnosis.
Exclusion criteria: Drug reaction, lapse from the study, Immigration or death, containdications for statins (pregnancy, lactation, abnormal liver function tests abnormality
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Approval date
2008-11-22, 1387/09/02
Ethics committee reference number
188099
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
Clinical and laboratory findings
Timepoint
Before the study and 3 months later
Method of measurement
DAS28, ESR, VAS
Secondary outcomes
1
Description
Better control of rheumatoid arthritis and prevention of joint destruction
Timepoint
Befor the study and 3 months later
Method of measurement
DAS28, ESR, VAS
Intervention groups
1
Description
One placebo tablet per day for 3 months
Category
Placebo
2
Description
Atorvastatin oral pills 40 mg one tablet per day for 3 months
Category
Treatment - Drugs
3
Description
Simvastatin oral pills 40 mg one tablet per day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mansour Salesi
Street address
Sofe Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery of research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Fallah
Street address
No#4 building, vice chancellery of research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery of research, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Salesi
Position
Rheumatologist/Assistant professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Salesi
Position
Rheumatologist/Assistant professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Salesi
Position
Rheumatologist/Assistant professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)