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

NCT06417138 | Recruiting DMC

• 1 other identifier: 2023-0-225
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis RA

Keywords

Rheumatoid Arthritis; Remission; Biological DMARDs; Targeted synthetic DMARDs; DAS-28-CRP; CDAI; Low disease activity; Comparative effectiveness; Efficacy

Outcome Measures

Primary Outcomes (2)

• To compare the effectiveness of different biological Disease Modifying Antirheumatic Drugs (bDMARDs) and targeted synthetic (tsDMARDs)

  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)

  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 Outcomes (1)

• Drug survival rate

  "through study completion, an average of 1 year"

Study Arms (1)

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)

Interventions

biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs) OTHER

This is a registry-based study. It is an observational, retrospective trial. There is/are no interventional drug(s).

Also known as: bDMARDs, tsDMARDs

Rheumatoid arthritis patients receiving biological DMARDs or targeted synthetic DMARDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Any patient who cannot recall the exact date of starting his drugs will be excluded during data analysis.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

International medical center

Jeddah, Mecca Region, 21451, Saudi Arabia

RECRUITING

Related Publications (4)

• Smolen JS, Landewe RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, Caporali R, Edwards CJ, Hyrich KL, Pope JE, de Souza S, Stamm TA, Takeuchi T, Verschueren P, Winthrop KL, Balsa A, Bathon JM, Buch MH, Burmester GR, Buttgereit F, Cardiel MH, Chatzidionysiou K, Codreanu C, Cutolo M, den Broeder AA, El Aoufy K, Finckh A, Fonseca JE, Gottenberg JE, Haavardsholm EA, Iagnocco A, Lauper K, Li Z, McInnes IB, Mysler EF, Nash P, Poor G, Ristic GG, Rivellese F, Rubbert-Roth A, Schulze-Koops H, Stoilov N, Strangfeld A, van der Helm-van Mil A, van Duuren E, Vliet Vlieland TPM, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):3-18. doi: 10.1136/ard-2022-223356. Epub 2022 Nov 10.

  PMID: 36357155 BACKGROUND

• Monti S, Montecucco C, Bugatti S, Caporali R. Rheumatoid arthritis treatment: the earlier the better to prevent joint damage. RMD Open. 2015 Aug 15;1(Suppl 1):e000057. doi: 10.1136/rmdopen-2015-000057. eCollection 2015.

  PMID: 26557378 BACKGROUND

• Finckh A, Gilbert B, Hodkinson B, Bae SC, Thomas R, Deane KD, Alpizar-Rodriguez D, Lauper K. Global epidemiology of rheumatoid arthritis. Nat Rev Rheumatol. 2022 Oct;18(10):591-602. doi: 10.1038/s41584-022-00827-y. Epub 2022 Sep 6.

  PMID: 36068354 BACKGROUND

• Almoallim H, Al Saleh J, Badsha H, Ahmed HM, Habjoka S, Menassa JA, El-Garf A. A Review of the Prevalence and Unmet Needs in the Management of Rheumatoid Arthritis in Africa and the Middle East. Rheumatol Ther. 2021 Mar;8(1):1-16. doi: 10.1007/s40744-020-00252-1. Epub 2020 Nov 23.

  PMID: 33226566 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Hani Almoallim, Professor

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hani Almoallim, Professor of Rheumatology

CONTACT

00966+505703935; hmmoallim@uqu.edu.sa

Suzan Attar, Professor of Rheumatology

CONTACT

00966+562222613; suzan_attar@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: December 15, 2023
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

SA (1)