General : To compare the effects of Tocilizumab and Rituximab on treatment-resistant rheumatoid arthritis in Luqman Hakim Medical Training Center
Specific:
• Determining patients with treatment-resistant rheumatoid arthritis and dividing them into two groups receiving Rituximab and Tocilizumab.
• Determination of pain score, activity, and ACR in the above two groups six months after the intervention
Design
Clinical trial with two treatment groups with parallel groups, randomized, phase 2 on 22 patients
Settings and conduct
. Patients with treatment-resistant rheumatoid arthritis will be randomly selected by the project manager
Demographic information will be collected using a checklist. Before the start of the intervention, in addition to the demographic characteristics of the patient activity index, the DAS28 criterion, the pain criterion and the ACR criterion will be evaluated and recorded for the patients. Patients will be randomly divided into two groups of 11 people. The first group will be injected with rituximab , and the second group will be injected with tocilizumab
After 6 months from the start of the intervention, the patient will be evaluated
Participants/Inclusion and exclusion criteria
inclusion :Definitive diagnosis of rheumatism resistant to at least one of the anti-rheumatic drugs (DMARDS) and resistance to methotrexate
Intervention groups
Patients will be randomly divided into two groups of 11 people. The first group with rituximab and the second group tocilizumab will be injected
Main outcome variables
Comparison of the effects of tocilizumab and rituximab
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20230923059495N1
Registration date:2024-03-31, 1403/01/12
Registration timing:retrospective
Last update:2024-03-31, 1403/01/12
Update count:0
Registration date
2024-03-31, 1403/01/12
Registrant information
Name
Elnaz Shafighi Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 0237
Email address
elnaz.shafighi3412@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
2022-08-23, 1401/06/01
Actual recruitment end date
2024-01-21, 1402/11/01
Trial completion date
2024-01-21, 1402/11/01
Scientific title
Comparison of the effect of tocilizumab and rituximab on rheumatoid arthritis treatment-resistant . Loghman-e Hakim hospital
Public title
Tocilizumab and rituximab in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having written informed consent to participate in the study
Age 18 to 65 years•
Weight less than 100 kg
Definite diagnosis of rheumatism resistant to at least one of the anti-rheumatic drugs (DMARDS) and also having resistance to methotrexate
Having moderate to severe rheumatoid arthritis with involvement of at least 4 painful joints and 4 swollen joints with ESR above 30 mm/h and CRP above 10 mg/l at the time of screening and entering the study
If taking DMARDS drugs, stop them at least 2 weeks before entering the study
The patient does not belong to functional class IV according to the ACR criteria.
Has not had a history of rituximab injection within 2 years before entering the study
During the 4 weeks before receiving tocilizumab, he has not received oral corticosteroids with a dose of more than 10 mg of prednisolone per day or other corticosteroids with an equivalent dose
Do not have a history of increasing the number or dosage of DMARDS drugs or immunosuppressive drugs during the 4 weeks before starting treatment with tocilizumab.•
He does not have a history of receiving live or weakened vaccine in less than 4 weeks before the start of the intervention.•
Do not have a history of allergy to both mentioned drugs.•
Has not had a history of performing plasmapheresis or major joint and cardiovascular surgeries during the 8 weeks prior to entering the study or did not intend to perform it during the 6 months of follow-up.•
Do not have a history of other rheumatism and malignancy in the last 5 years.
No history of treatment with ciclosporin and tacrolimus within 1 month before the intervention and no history of treatment with tocilizumab.
The patient has normal GFR and liver enzymes
Do not have a history of thrombocytopenia and AIDS, hepatitis B and C viral infections•
Not taking drugs that interfere with rituximab or tocilizumab
Exclusion criteria:
Lack of consent to continue treatment in the study
Death of the patient for any reason before the completion of the follow-up
Undergoing joint surgery
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
11
11 patients with rheumatoid arthritis received tocilizumab
Actual sample size reached:
22
More than 1 sample in each individual
Actual sample size in each individual:
11
11 patients with rheumatoid arthritis received rituximab
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence generation will be done in the form of simple randomization and by preparing and flipping cards. So that a number of cards will be prepared as the first group and the same number of cards will be prepared for the next group. Then by flipping them, one card will be prepared. is taken out and its allocation is recorded and that card is returned to the other cards again. This process will continue until reaching a sequence according to the sample size.
Random allocation will also be hidden by placing the above cards in non-transparent sealed envelopes. The research team that is in charge of the above steps will not enter into other steps of the research, especially the examination of people in terms of dependent variables.
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
Shahid Beheshty Medical University Ethics Committee
Street address
Shahid Beheshty University, Darakeh Avenue
City
Tehran
Province
Tehran
Postal code
9816867393
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SBMU.MSP.REC.1402.538
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
Rituximab, Tosilizumab
Timepoint
6 month
Method of measurement
Patients activity, DAS28, PAP pain, ACR
Secondary outcomes
empty
Intervention groups
1
Description
InterIntervention group 1 : The first group of rituximab drug with a dose of 1 gram will be injected intravenously (IV) at one time.
Category
Treatment - Drugs
2
Description
Intervention group 2: The second group of tucilizumab drug with 20mg/2weeks /sc for 6 months will be injected intravenously (IV).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loqman hospital
Full name of responsible person
Elnaz Shafighi Shahri
Street address
Shahid Beheshti University of Medical Sciences, Durke Street, Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
9816867393
Phone
+98 21 5102 5000
Email
elnaz.shafighi3412@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Shahid Beheshti University of Medical Sciences, Durke St
City
Tehran
Province
Tehran
Postal code
9816867393
Phone
+98 21 5021 5000
Email
elnaz.shafighi3412@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Shafighi Shahri
Position
Fellowship of Rheumatology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti University of Medical Sciences, Durke St
City
Tehran
Province
Tehran
Postal code
9816867393
Phone
+98 21 5021 5000
Email
elnaz.shafighi3412@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Shafighi Shahri
Position
Fellowship of rheumatology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti University of Medical Sciences, Durke St
City
Tehran
Province
Tehran
Postal code
9816867393
Phone
+98 21 5021 5000
Email
elnaz.shafighi3412@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Shafighi Shahri
Position
Fellowship of Rheumatology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti University of Medical Sciences, Durke St
City
TEHRAN
Province
Tehran
Postal code
9816867393
Phone
0098215021500000
Email
ELNAZ.SHAFIGHI3412@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Collegue persons
Under which criteria data/document could be used
Justly treatment
From where data/document is obtainable
Elnaz Shafighi Shahri
00989155421275
What processes are involved for a request to access data/document