Evaluation of factors that affect the response to Etanercept and Adalimumab in treatment of Joint involvement in patients with Spondyloarthropathy and Rheumathoid Arthritis reffered to rheumatology clinics in Hamedan
Investigating the factors related to the response rate to etanercept and adalimumab in the treatment of joint symptoms in patients with rheumatoid arthritis and Spondyloarthritis
Design
Clinical trial with two randomized parallel groups, which is performed on 74 patients with Rheumatoid Arthritis and 74 patients with Spondyloarthritis.
Settings and conduct
Patients with Rheumatoid arthritis and Spondyloarthropathy who did not have a clinical response to the first line of treatment are included in this study.
These patients are randomly divided into two groups ; the first group is treated with Etanercept , and the second group is treated with Adalimumab .
12 weeks later, the patients are visited again and the response to treatment is calculated in patients . Then, the factors that have been related to the response to the treatment are compared
Participants/Inclusion and exclusion criteria
All patients with a definite diagnosis of Rheumatoid arthritis or spondyloarthropathy who are candidates for receiving Tumor Necrosis Factor inhibitors, are included in the study. Patients who have contraindications for the administration of Tumor Necrosis Factor inhibitors; Patient's unwillingness to cooperate; were excluded from the study.
Intervention groups
The first group is treated with Etanercept and the second group is treated with Adalimumab
Main outcome variables
In patients with Rheumatoid arthritis we use general evaluation of the patient, the number of tender joints, the number of swollen joints, the level of C-reactive protein and the erythrocyte sedimentation rate.
In patients with spondyloarthropathy ,a checklist will be completed by the patient, which includes joint pain, weakness and morning stiffness.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240309061221N1
Registration date:2024-03-27, 1403/01/08
Registration timing:retrospective
Last update:2024-03-27, 1403/01/08
Update count:0
Registration date
2024-03-27, 1403/01/08
Registrant information
Name
Ahmad Tahamoli Rudsari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0705
Email address
anis.maleki1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2023-11-22, 1402/09/01
Trial completion date
2023-11-22, 1402/09/01
Scientific title
Evaluation of factors that affect the response to Etanercept and Adalimumab in treatment of Joint involvement in patients with Spondyloarthropathy and Rheumathoid Arthritis reffered to rheumatology clinics in Hamedan
Public title
Evaluation of factors that affect the response to Etanercept and Adalimumab in treatment of Joint involvement in patients with Spondyloarthropathy and Rheumathoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with a definitive diagnosis of rheumatoid arthritis or spondyloarthropathy who are candidates for receiving anti-TNF drugs.
Exclusion criteria:
The existence of contraindications for the administration of anti-TNF (history of MS, unexplained pancytopenia, heart failure class 2 and higher, presence of active infection, etc.)
The patient's unwillingness to cooperate
Inability to pay for medication
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
148
Actual sample size reached:
148
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamedan University of Medical Sciences
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.UMSHA.REC.1402.023
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
2
Description of health condition studied
Ankylosing spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis
Primary outcomes
1
Description
In Rheumatoid arthritis, DAS28 less than 3.3 is considered a response to treatment; In spondyloarthropathy, BASDAI above 4 is associated with high disease activity, and a decrease of 2 points after treatment is considered a response to treatment.
Timepoint
12 weeks after administration of the medication
Method of measurement
The response to treatment in patients with Rheumatoid arthritis is calculated using DAS-28 criteria and in Spondyloarthropathy patients using BASDAI criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group is treated with Etanercept 50 mg once a week.Duration of the treatment is until the control of the symptoms.
Category
Treatment - Drugs
2
Description
Intervention group: The second group is treated with Adalimumab 40 mg once every two weeks.Duration of the treatment is until the control of the symptoms.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology clinic of Shahid Beheshti Hospital
Full name of responsible person
Ahmad Tahamol Rudsari
Street address
Eram Blvd
City
Hamedan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0704
Email
shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokuhi
Street address
Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3131 4033
Email
webda@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
Ahmad Tahamoli Rudsari
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Eram Blvd
City
Hamedan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0705
Email
ahmadtahamoli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ahmad Tahamoli Rudsari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Eram Boulevard، shahid beheshti hospital
City
Hamedan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0705
Fax
Email
ahmadtahamoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ahmad Tahamoli Rudsari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Eram Boulevard، shahid beheshti hospital
City
Hamedan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0705
Fax
Email
ahmadtahamoli@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