Rheumatoid Arthritis RANCT06417138
Comparative Effectiveness of Different Drugs Used to tr€at Patients in Rheumatoid Arthritis Saudi Database (RASD)"
An observational study of Rheumatoid Arthritis RA, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis RA
- What is being tested?
- biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)
- How many people
- 800 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Dec 2023to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
International medical center
Jeddah, Mecca Region, 21451
Hani Almoallim, Professor of Rheumatology, 604-880-4427, hmmoallim@uqu.edu.sa
About this study
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.
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).
Read more
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis RA
- Being tested
- biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)
- Keywords
- Rheumatoid Arthritis, Remission, Biological DMARDs, Targeted synthetic DMARDs, DAS-28-CRP, CDAI, Low disease activity, Comparative effectiveness, Efficacy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)Other
Also called bDMARDs, tsDMARDs
This is a registry-based study. It is an observational, retrospective trial. There is/are no interventional drug(s).
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Other: biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: "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)
Measured: "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.
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 Dec 2023
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hani Mohammad Almoallim, Umm Al-Qura University
- Investigators
- Hani Almoallim, Professor, Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417138
- Sponsor's protocol ID
- 2023-0-225
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36357155Monti 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.
PubMed 26557378Finckh 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.
PubMed 36068354Almoallim 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.
PubMed 33226566Almoallim HM, Bahlas SM, Bawazir Y, Hussein AH, Attia GM, Manasfi H, Bafadhl ZA, Asiri AM, Ali AR, Alomair MM, Alsharaif MM, Almalki HH, Siddiqui MI, Alhazmi AS, Attar SM. Real-World Effectiveness of Biologic and Targeted Synthetic Therapies in Rheumatoid Arthritis: a Multicenter Study from Rheumatoid Arthritis Saudi Database (RASD). Open Access Rheumatol. 2026 Jun 15;18:613886. doi: 10.2147/OARRR.S613886. eCollection 2026.
PubMed 42325590
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06417138
- Acronym / sponsor ID
- 2023-0-225
- Conditions
- Rheumatoid Arthritis RA
- Keywords
- Rheumatoid Arthritis, Remission, Biological DMARDs, Targeted synthetic DMARDs, DAS-28-CRP, CDAI, Low disease activity, Comparative effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients receiving biological DMARDs or targeted synthetic DMARDs | – | Other: biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological and targeted synthetic disease modifying anti rheumatic drugs (bDMARDs) and (tsDMARDs)Also: bDMARDs, tsDMARDsThis is a registry-based study. It is an observational, retrospective trial. There is/are no interventional drug(s). | Other | Rheumatoid arthritis patients receiving biological DMARDs or targeted synthetic DMARDs |
Primary outcome
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)
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)
1 secondary outcome
Drug survival rate
Time frame: "through study completion, an average of 1 year"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 36357155Smolen 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.
- Background: PubMed 26557378Monti 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.
- Background: PubMed 36068354Finckh 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.
- Background: PubMed 33226566Almoallim 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.
- Derived from this study: PubMed 42325590Almoallim HM, Bahlas SM, Bawazir Y, Hussein AH, Attia GM, Manasfi H, Bafadhl ZA, Asiri AM, Ali AR, Alomair MM, Alsharaif MM, Almalki HH, Siddiqui MI, Alhazmi AS, Attar SM. Real-World Effectiveness of Biologic and Targeted Synthetic Therapies in Rheumatoid Arthritis: a Multicenter Study from Rheumatoid Arthritis Saudi Database (RASD). Open Access Rheumatol. 2026 Jun 15;18:613886. doi: 10.2147/OARRR.S613886. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hani Almoallim, Professor principal investigator
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis RA, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hani Almoallim, Professor of Rheumatology (00966+505703935, hmmoallim@uqu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417138, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.