Determination of the effect of metformin on decreasing the activity and severity of rheumatoid arthritis disease
Design
This is a controlled double-blind clinical trial study conducted on 60 patients with rheumatoid arthritis. Patients (N= 30 per group) are randomly treated with metformin or placebo for 12 weeks.
Settings and conduct
60 patients referred to the rheumatology clinic of Golestan and Imam Khomeini hospitals in Ahvaz. They are classified based on mild to high severity of rheumatoid arthritis according to ACR2010 criteria who are randomly divided into two groups of 30 people. The intervention group receives metformin 500 mg twice a day and the case group also receives placebo 500 mg twice a day. After 12 weeks, activity and severity of disease based on DAS28 score as well as TJC, CRP, and ESR of patients are evaluated by a rheumatologist in two groups.
Participants/Inclusion and exclusion criteria
Patients with moderate to high severity of rheumatoid arthritis based on DAS28 scale
Intervention groups
Duration of illness over 3 years, there is significant kidney disorder that forbids from using metformin (GFR <30), pregnancy, significant heart failure (EF <50%), chronic hepatic impairment or acute liver failure, having diabetes or previous and recent use of metformin, the last 3 months of anti-inflammatory drugs, new drug added to control patient symptoms during treatment
The effect of metformin on decreasing activity and severity of rheumatoid arthritis disease (pilot study)
Public title
The effect of metformin on decreasing the severity of rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to high severity of rheumatoid arthritis based on the DAS28 scale
Exclusion criteria:
Duration of illness over 3 years
There is significant kidney disorder that forbids from using metformin (GFR <30)
Pregnancy
Significant heart failure (EF <50%)
Chronic hepatic impairment or acute liver failure
Having diabetes or previous and recent use of metformin
The last 3 months of anti-inflammatory drugs
New drug added to control patient symptoms during treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
By random block permutation, individuals will be divided into two groups. The block sizes can be 4, 6 and so on. 6 blocks including 4 characters will be considered; AABB, ABAB, BBAA, BABA, ABBA, and BAAB. We will sample from the six blocks with replacement to the extent that the sample size is completed. In this case, a sequence of letters will be obtained, in which individuals will be randomly divided into two equal groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
All medications will be in similar and dark pockets. A numeric label will be on each pack of medications. Patient and researcher will not inform of the number assigned to the relevant group. Then, according to the random sequence based on random block permutation, the packets of medications will be given to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-157941
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.AJUMS.REC.1397.429
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Disease severity
Timepoint
At baseline and after treatment (12 weeks)
Method of measurement
DAS28
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and after treatment (12 weeks)
Method of measurement
Western Green analysis
3
Description
Swollen joint count (SJC)
Timepoint
At baseline and after treatment (12 weeks)
Method of measurement
Examination and clinical judgment of the physician
4
Description
Tender joint count (TJC)
Timepoint
At baseline and after treatment (12 weeks)
Method of measurement
Examination and clinical judgment of the physician
5
Description
CRP
Timepoint
At baseline and after treatment (12 weeks)
Method of measurement
Aagglutination test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Metformin (Najo Company, Iran) is given at a dose of 500 mg twice a day for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo (made in School of Pharmacy, Ahvaz University of Medical Sciences) is given at a dose of 500 mg twice a day for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Sajedeh Igder
Street address
Imam Khomeini Hospital.,Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
himam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Sajedeh Igder
Street address
Golestan Hospital, Farvardin Ave., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Drsajedehigder3393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Jundishapur University of Medical Sciences, Chancellor for Research and Technology Development, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8286
Fax
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sajedeh Igder
Position
Internal Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital., Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
Drsajedehigder3393@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Mowla
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jundishapur University of Medical Sciences, Golestan Bldv.
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Mowla_k@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ُSajedeh Igder
Position
Internal Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital., Azadegan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2114
Email
Drsajedehigder3393@gmail.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available