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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmm Al-Qura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Rheumatoid arthritis patients receiving biological DMARDs or targeted synthetic DMARDs1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
"through study completion, an average of 1 year"
2

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)

Time frame
"through study completion, an average of 1 year"

Secondary outcomes

1

Drug survival rate

The time that a specific drug has been used by the patient.

Time frame
"through study completion, an average of 1 year"

Other outcomes

Sponsors and contacts

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