Comparative Effectiveness of Different Drugs Used to tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)"

June 6, 2024 updated by: Hani Mohammad Almoallim, Umm Al-Qura University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  • 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 0.05

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 Levene's 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 Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hani Almoallim, Professor of Rheumatology
  • Phone Number: 00966+505703935
  • Email: hmmoallim@uqu.edu.sa

Study Contact Backup

Study Locations

  • Saudi Arabia
    • Makkah
      • Jeddah, Makkah, Saudi Arabia, 21451
        • Recruiting
        • International Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid Arthritis patients who are enrolled in our rheumatoid arthritis Saudi Database will be included according the inclusion and exclusion criteria above. Other centers who are not part of RASD will be included as well as long as they will comply with study protocol and provide data as required.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis patients receiving biological DMARDs or targeted synthetic DMARDs
It will be 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".
Other: biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)
This is a registry-based study. It is an observational, retrospective trial. There is/are no interventional drug(s).
Other Names:
  • bDMARDs
  • tsDMARDs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Disease Activity Score for 28 joints with C-Reactive Protein (DAS-28-CRP) (Remission <1.6, Low Disease Activity<2.4, Moderate Disease Activity<3.7, High Disease Activity >3.7)
"through study completion, an average of 1 year"
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)
"through study completion, an average of 1 year"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug survival rate
Time Frame: "through study completion, an average of 1 year"
The time that a specific drug has been used by the patient.
"through study completion, an average of 1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umm Al-Qura University

Investigators

  • Principal Investigator: Hani Almoallim, Professor, Umm Al-Qura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

February 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0-225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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