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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Umm Al-Qura University
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- To compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs (bDMARDs) and targeted synthetic (tsDMARDs)
Study Overview
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 question[s] 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 patient's overall wellbeing. RA has a global prevalence rate of 0.5-1.1% 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 disease's 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All those patients who are age of 18 years and above and
- •meeting 2010 American College of Rheumatology classification criteria for rheumatoid arthritis.
- •Both male and female gender will be included.
- •There should be minimum of 12 months follow up with at least 3 documented visits of these patients to health care facilities.
Exclusion Criteria
- •Any patient who did not meet the inclusion criteria will be excluded from the study.
- •Any patient who cannot recall the exact date of starting his drugs will be excluded during data analysis.
Outcomes
Primary Outcomes
To compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs (bDMARDs) and targeted synthetic (tsDMARDs)
Time Frame: "through study completion, an average of 1 year"
Using Clinical Disease Activity Index (CDAI) (Remission \<2.8, Low Disease Activity \<10, Moderate Disease Activity \<22, High Disease Activity \>22)
Secondary Outcomes
- Drug survival rate("through study completion, an average of 1 year")
Investigators
Hani Mohammad Almoallim
Professor of Rheumatology
Umm Al-Qura University