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Evaluation of the effect of Adalimumab on mitochondrial function and Sonic hedgehog signaling pathway in peripheral blood mononuclear cells in rheumatoid arthritis patients

Protocol summary

Study aim
Determination of the effect of Adalimumab on mitochondrial function and Sonic hedgehog signaling pathway in peripheral blood mononuclear cells in rheumatoid arthritis patients
Design
Before and after clinical trial, no control group, no randomization, pilot study on 10 patients, The final sample size will be calculated using the results of an pilot study.
Settings and conduct
Prospective study, comparative clinical trial (before and after treatment), rheumatoid arthritis patients in Shahid Beheshti Medical Center, Hamadan. Confirmation of disease based on ACR criteria. Patients based on clinical signs and paraclinical findings and obtaining informed written consent; Will be selected to participate in the study. During the study, patients continued the initial treatment protocol, including conventional DMARDs, including methotrexate. Treatment with Adalimumab is started at the same time. Blood samples before and after 12 weeks of treatment, tests related to mitochondrial function and Sonic hedgehog messaging pathway, oxidative stress and apoptosis
Participants/Inclusion and exclusion criteria
Inclusion critria: Informed and voluntary consent Passing the initial treatment period Sero positive patients will be included in the study Preparation for receiving biological medicine with physician approval Exclusion critria: All patients with a history of autoimmune, inflammatory, infectious disease in the last 6 months Taking biologic anti-TNF drug Previous treatment with adalimumab
Intervention groups
There is only one intervention group: Rheumatoid arthritis patients who are prepared to receive adalimumab with a doctor's approval. The effect of the drug on them before and after treatment is evaluated. The drug will be injected 40 mg every two weeks for 12 weeks.
Main outcome variables
Reactive Oxygen Species, Mitochondrial membrane potential, Adenosine Triphosphate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211005052683N1
Registration date: 2021-11-23, 1400/09/02
Registration timing: registered_while_recruiting

Last update: 2021-11-23, 1400/09/02
Update count: 0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Anahita Abbasifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 8959
Email address
a.abbasi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Adalimumab on mitochondrial function and Sonic hedgehog signaling pathway in peripheral blood mononuclear cells in rheumatoid arthritis patients
Public title
Evaluation of the effect of Adalimumab in rheumatoid arthritis patients
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and voluntary consent Passing the initial treatment period Sero positive patients will be included in the study Preparation for receiving biological medicine with physician approval
Exclusion criteria:
All patients with a history of autoimmune, inflammatory, infectious disease in the last 6 months taking biologic anti-TNF drug previous treatment with adalimumab
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 2
blood sample
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study was designed as a comparative clinical trial (before and after treatment) on patients with rheumatoid arthritis. Due to the lack of sufficient information, the final sample size cannot be calculated. The pilot study was performed on 10 people. According to the results, the final sample size is calculated.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Ethics committee of Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UMSHA.REC.1400.502

Health conditions studied

1

Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor

Primary outcomes

1

Description
Determining the effect of adalimumab on mitochondrial function
Timepoint
Before and after taking the drug
Method of measurement
Reactive oxygen species and mitochondrial membrane potential are assessed by flow cytometry and Adenosine Triphosphate by luminescence. The sum of these cases indicates mitochondrial function.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rheumatoid arthritis patients will receive 40 mg of adalimumab (SinnoRa) by injection every two weeks for 12 weeks. The drug is a product of Sinnagen Company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Medical Educational Center
Full name of responsible person
Alireza Fazaeli
Street address
Qaem Square
City
Hamadan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0283
Fax
+98 81 3838 1035
Email
Shahidbeheshti@umsha.ac.ir
Web page address
http://beheshti.umsha.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Vice-chancellor for research and technology, Hamadan University of Medical Sciences, Shahid Fahmideh boulevard
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1970
Email
Fanavari@umsha.ac.ir
Web page address
http://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Anahita Abbasifard
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.abbasifard722@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Heidar Tayebinia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh street.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0208
Email
tavilani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Anahita Abbasifard
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0208
Fax
Email
a.abbasifard722@gmail.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data can potentially be shared after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Be a faculty member or researcher in the field. It can also be used for review and meta-analysis articles.
From where data/document is obtainable
Student Executor: Anahita Abbasifard a.abbasifard722@gmail.com
What processes are involved for a request to access data/document
After approval by the ethics committee and in consultation with the research team
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