## Protocol Section
### Identification Module
**NCT ID:** NCT06417138

**Brief Title:** "Comparative Effect of Different Drugs Used to Tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)"

**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.

#### Organization Study ID Info
**ID:** 2023-0*225
#### Organization
**Class:** OTHER
**Full Name:** Umm Al-Qura University
### Status Module
#### Completion Date
**Date:** 2025-03-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-15

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Umm Al-Qura University

#### Responsible Party

**Investigator Affiliation:** Umm Al-Qura University

**Investigator Full Name:** Hani Mohammad Almoallim

**Investigator Title:** Professor of Rheumatology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Comparative effectiveness of different drugs used to treat patients in Rheumatoid Arthritis Saudi database (RASD)

Introduction

Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported 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(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3).

In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag time from the onset of symptoms until the initiation of treatment in patients with RA has been collectively calculated to be around almost one year time (5).

Diseases modifying anti rheumatic agents (DMARDS) are the main drugs used for the management of RA, and it mainly reduce the inflammation and improve the outcomes(6). Several DMARSs drugs are available for the management of RA, however, recently, biological DMARDS have also been widely used and recommended in case the conventional DMARDS fail to control the diseases(6,7). Worldwide, there have been multiple studies that examined the effectiveness of DMARDS and bDMARDS drugs for the management of RA, this include large controlled trials which are the gold standard method for investigating medications efficacy(8,9). However, observational real-world data to examine the effectiveness of these medications is also important and can be more generalizable, have longer follow up and can examine different characteristics. Previous observational studies investigating the effectiveness of DMARDS and bDMARDS were mainly in Europe and North America which does not necessarily represent the current situation and the characteristics of the middle eastern population(10,11), as there is so much variability in access to different biological drugs in different countries. In addition, these studies did not compare treatment lines. In the middle east there were limited studies that addressed the effectiveness of different drugs used to treat RA in Saudi Arabia(5,12-14). These studies were mainly cross sectional in nature or reviews, and it is difficult to draw any conclusions with such study designs. Therefore, this research is to compare the effectiveness of multiple DMARDS medication for the treatment of RA patients in Saudi Arabia.

Literature Review

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 (1). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis. RA is strongly associated with the female gender, with a female to male ratio of 2:1 to 3:1. Smoking habits have also been shown to both increase the risk of acquiring RA and of worsening its prognosis(1,15).

Early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state. A study found that only 31% of RA patients visited a rheumatologist within less than 12 weeks of symptom onset, those who did had ameliorated progression rates at 6 years as measured by the Sharp/van der Heijde score (SHS) as well as higher rates of DMARD-free remission than patients who delayed their presentation to more than 12 weeks (16) Even though the importance of optimal treatment has been demonstrated, in Africa and the Middle East diagnoses are often delayed for months or even years after symptom onset(5,12,17,18) Our group conducted a study in Saudi Arabia showed that patients may not receive a diagnosis of RA for up to 30 months after the onset of symptoms (12). Raising public awareness of RA and treatment options is also an important tool for reducing time to diagnosis(17). Public education programs can lead to earlier diagnosis and initiation of therapy, as observed in patients in the United Arab Emirates(19). Increased public awareness may also lead to patients with symptoms of RA visiting rheumatology clinics rather than other specialties, thereby receiving adequate and timely treatment.

Delayed diagnoses can be attributed to a variety of reasons. In

### Conditions Module

**Conditions:**

- Rheumatoid Arthritis RA

**Keywords:**

- Rheumatoid Arthritis

- Remission

- Biological DMARDs

- Targeted synthetic DMARDs

- DAS-28-CRP

- CDAI

- Low disease activity

- Comparative effectiveness

- Efficacy

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 800

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** 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.

**Time Frame:** one year OR completion of 3 visits - 3 months apart

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All those patients who are \&amp;amp;amp;gt;age of 18 years, 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. In addition, any patient who cannot recall the exact date of starting his drugs will be excluded during data analysis.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Rheumatoid arthritis (RA) is a chronic inflammatory disease-causing significant disability among patients(1). The prevalence rate of RA varies based on the geographical locations, however, several reviews reported 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(1,2). Of this population, the World Health Organization reports that 50% will not be able to hold a sustainable job after 10 years of diagnosis . In Saudi Arabia, recent and generalisable epidemiological data regarding RA in Saudi Arabia are limited and suboptimal(1). One study by Al Dalaan et al in 1998, that was conducted in Al-Qassim region reported that the prevalence rate of RA is about 0.2%(3).

In patients with RA, early diagnosis was found to halt the ailment's relentless progression to joint destruction which carried a detrimental effect on the patient's functional and psychological state (4). However, the international lag ti

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hmmoallim@uqu.edu.sa

**Name:** Hani Mohammad O Almoallim Principal investigator, MBBS Professor of Rheumatology

**Phone:** 00966+505703935

**Role:** CONTACT

**Contact 2:**

**Email:** suzan_attar@hotmail.com

**Name:** Suzan Mahmoud Attar, Professor of Rheumatology

**Phone:** 00966+562222613

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4480

- Name: Arthritis, Rheumatoid

- Relevance: HIGH

- As Found: Rheumatoid Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001172

- Term: Arthritis, Rheumatoid

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
