Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417138
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-13
Brief Title:
Comparative Effectiveness of Different Drugs Used to trat Patients in Rheumatoid Arthritis Saudi Database RASD
Sponsor:
Umm Al-Qura University
Organization:
Umm Al-Qura University
Study Overview
Official Title:
Comparative Effectiveness of Different Drugs Used to Treat Patients in Rheumatoid Arthritis Saudi Database RASD The Primary Objective of This Study is to Compare the Effectiveness of Different Biological Disease Modifying Antirheumatic Drugs bDMARDs and Targeted Synthetic tsDMARDs Using DAS-28-CRP and CDAI Scores
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative effectiveness of different drugs used to treat patients in Rheumatoid Arthritis Saudi database RASD
The goal of this observational study is to compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs bDMARDs and targeted synthetic tsDMARDs using Disease Activity Score - 28 joints - C-Reactive Protien DAS-28-CRP and Clinical Disease Activity Index CDAI scores In rheumatoid arthritis patients in Saudi Arabia who are part of Rheumatoid Arthritis Saudi Database RASD
The main questions it aims to answer
What is the most effective drug biologocal or targeted synthetic disease modifying antirheumatic drug used to treat rheumatoid arthritis in Saudi Arabia
We are going to use two outcome mesures Disease Activity Score - 28 joints - C-Reactive Protien DAS-28-CRP and Clinical Disease Activity Index CDAI scores
Researchers will compare the treatment of rheumatoid arthritis using specific outcome measures in Rheumatoid Arthritis in Saudi Arabia
Participants will be enrolled after a signed written concent in our Rheumatoid Arthritis Saudi Databas RASD
Their treatment data will used to compare the effectiveness of different drugs they are using
The goal of this observational study is to compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs bDMARDs and targeted synthetic tsDMARDs using Disease Activity Score - 28 joints - C-Reactive Protien DAS-28-CRP and Clinical Disease Activity Index CDAI scores In rheumatoid arthritis patients in Saudi Arabia who are part of Rheumatoid Arthritis Saudi Database RASD
The main questions it aims to answer
What is the most effective drug biologocal or targeted synthetic disease modifying antirheumatic drug used to treat rheumatoid arthritis in Saudi Arabia
We are going to use two outcome mesures Disease Activity Score - 28 joints - C-Reactive Protien DAS-28-CRP and Clinical Disease Activity Index CDAI scores
Researchers will compare the treatment of rheumatoid arthritis using specific outcome measures in Rheumatoid Arthritis in Saudi Arabia
Participants will be enrolled after a signed written concent in our Rheumatoid Arthritis Saudi Databas RASD
Their treatment data will used to compare the effectiveness of different drugs they are using
Detailed Description:
Rheumatoid arthritis RA is a chronic progressive inflammatory disease that causes irreversible joint deformities which can have debilitating effects on a patients overall wellbeing RA has a global prevalence rate of 05-11 with an annual incidence rate of 20-50 cases per 100 000 of the American and North European population
Registries are widely mentioned in literature as a method that studied a given population in a way that is more applicable to clinical practice Although there are numerous registries that previously set place in Europe and north America the middle east and Africa remain scarcely studied with a few published small scaled hospital reports Registries are imperative to study a diseases unique course in each population which may or may not align with its counterparts in western populations Therefore we established a Saudi registry for rheumatoid arthritis called Rheumatoid Arthritis Saudi Database RASD
We have published the results of RASD from one center recently Our study was conducted in a single center in Saudi Arabia using a pool of 433 patients The aim was to describe the population of rheumatoid arthritis and to compare these findings to previously published data registries
Currently RASD has expanded to include several centers in Saudi Arabia It is essential to conduct a study that address the comparative effectiveness of different drugs used to treat RA in Saudi population There are many reasons that make management of RA in our country different than other places in the world This study should help us to compare our comparative effectiveness to other studies with similar methodologies that reported on effectiveness in different population than ours We may include centers who are even not part of our RASD as long as they can provide a minimum of one year data on their RA patients with at least 3 visits describing the outcome measures that we are interested in
By the end of this research project the following information will be available for health care leaders for strategic planning The effectiveness of different biological and targeted synthetic DMARDs in Saudi population showing the most effective and the least effective drug This information can help in the following
Guide the development of a local guidelines focusing on the use of the most effective drugs in our population
Prioritizing the use of different drugs to treat RA in Saudi population
The drug survival rates and the discontinuation rates of different drugs in Saudi population
This is a multicenter study The data will be obtained primarily from Rheumatoid Arthritis Saudi Database RASD We will also include RA patients from other centers who are not part of the registry if they are providing minimum of 12 months follow up with at least 3 documented visits of these patients to health care facilities following treat to target approach or preferably treat to work approach
For the comparison of drug efficacy the best level of evidence is obtained by blinded randomized control design however use of data of registry is also an acceptable option with known limitation This is a retrospective study design We will observe all the cohorts of registry as well as those meeting the criteria to find out the most effective drug for the treatment of rheumatoid arthritis as well as to find out the association of various risk factors with the treatment outcome
We will use non probability convenience sampling technique to enroll the patients
Sample size Sample size was calculated as 798 based on a confidence interval of 95 and power of 80 with a p value of less than 005
All the collected data will be entered in SPSS version 22 edited cleaned and analyzed Categorical data will be measured by proportion and percentages while continuous data will be measured by mean and standard deviated where normality assumption is met Homogeneity of variables will be measured by Levenes test for equality of variance Student t test will be used to compare between two groups and ANOVA for the more than two groups in case of continuous data For the categorical data Chi-Square test will be used for large data and Fisher Exact test for smaller data Logistic regression model will be used in order to predict the outcome
Exposure and outcome variables included Age of patient Age of onset sex urban vs rural areas level of education comorbidities number of drugs used before using biological and targeted synthetic DMARDs duration of methotrexate use before starting biological and targeted synthetic DMARDs effectiveness of drugs lag time drug survival rate
Registries are widely mentioned in literature as a method that studied a given population in a way that is more applicable to clinical practice Although there are numerous registries that previously set place in Europe and north America the middle east and Africa remain scarcely studied with a few published small scaled hospital reports Registries are imperative to study a diseases unique course in each population which may or may not align with its counterparts in western populations Therefore we established a Saudi registry for rheumatoid arthritis called Rheumatoid Arthritis Saudi Database RASD
We have published the results of RASD from one center recently Our study was conducted in a single center in Saudi Arabia using a pool of 433 patients The aim was to describe the population of rheumatoid arthritis and to compare these findings to previously published data registries
Currently RASD has expanded to include several centers in Saudi Arabia It is essential to conduct a study that address the comparative effectiveness of different drugs used to treat RA in Saudi population There are many reasons that make management of RA in our country different than other places in the world This study should help us to compare our comparative effectiveness to other studies with similar methodologies that reported on effectiveness in different population than ours We may include centers who are even not part of our RASD as long as they can provide a minimum of one year data on their RA patients with at least 3 visits describing the outcome measures that we are interested in
By the end of this research project the following information will be available for health care leaders for strategic planning The effectiveness of different biological and targeted synthetic DMARDs in Saudi population showing the most effective and the least effective drug This information can help in the following
Guide the development of a local guidelines focusing on the use of the most effective drugs in our population
Prioritizing the use of different drugs to treat RA in Saudi population
The drug survival rates and the discontinuation rates of different drugs in Saudi population
This is a multicenter study The data will be obtained primarily from Rheumatoid Arthritis Saudi Database RASD We will also include RA patients from other centers who are not part of the registry if they are providing minimum of 12 months follow up with at least 3 documented visits of these patients to health care facilities following treat to target approach or preferably treat to work approach
For the comparison of drug efficacy the best level of evidence is obtained by blinded randomized control design however use of data of registry is also an acceptable option with known limitation This is a retrospective study design We will observe all the cohorts of registry as well as those meeting the criteria to find out the most effective drug for the treatment of rheumatoid arthritis as well as to find out the association of various risk factors with the treatment outcome
We will use non probability convenience sampling technique to enroll the patients
Sample size Sample size was calculated as 798 based on a confidence interval of 95 and power of 80 with a p value of less than 005
All the collected data will be entered in SPSS version 22 edited cleaned and analyzed Categorical data will be measured by proportion and percentages while continuous data will be measured by mean and standard deviated where normality assumption is met Homogeneity of variables will be measured by Levenes test for equality of variance Student t test will be used to compare between two groups and ANOVA for the more than two groups in case of continuous data For the categorical data Chi-Square test will be used for large data and Fisher Exact test for smaller data Logistic regression model will be used in order to predict the outcome
Exposure and outcome variables included Age of patient Age of onset sex urban vs rural areas level of education comorbidities number of drugs used before using biological and targeted synthetic DMARDs duration of methotrexate use before starting biological and targeted synthetic DMARDs effectiveness of drugs lag time drug survival rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None