A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunom… (NCT06714461) | Clinical Trial Compass
CompletedNot Applicable
A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
France302 participantsStarted 2025-05-05
Plain-language summary
The main objective of this post-authorization safety study is to assess healthcare professionals' awareness, knowledge, and behavior related to receipt and reading of the Direct Healthcare Professional Communication and educational materials for ARAVA® (leflunomide) and of the additional risk minimization measures.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthcare professionals working only in Saudi Arabia
* For Prescribers: Orthopedics, Internists, Family Physicians, General Practitioners, Dermatologists, Obstetricians/Gynecologists, Immunologists, and Rheumatologists who prescribed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion
* For Prescribers: Physicians or pharmacists who have prescribed or dispensed leflunomide in a pre-specified period of the 6 months leading up to survey completion
* For Pharmacists: Pharmacists (including clinical pharmacists) who have dispensed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion
Exclusion Criteria:
* Healthcare professionals who may have conflicts of interest with the survey (i.e., employed by regulatory bodies or pharmaceutical companies)
* Healthcare professionals (with a relative) involved in leflunomide -related lawsuits or associations for victims of leflunomide syndrome
* Healthcare professionals who are not prescribing leflunomide
* Healthcare professionals who have prescribed or dispensed leflunomide earlier than 6 months before the survey completion
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is already completed and focused on whether doctors in Saudi Arabia actually read and used the 2022 safety guidelines for leflunomide — can you tell me whether you're familiar with those updated risk minimization materials, and how they affect the way you'd monitor me if I were prescribed leflunomide?
2Since this trial was measuring whether healthcare providers are counseling patients and ordering the right lab tests based on the 2022 leflunomide safety guidelines, what specific blood tests or monitoring would you do for me before and during leflunomide treatment?
3Leflunomide carries known risks that prompted these formal safety education efforts — can you walk me through what those risks are and how they would apply to my specific situation with rheumatoid or psoriatic arthritis?
4Given that this was a Phase NA observational study looking at doctor awareness rather than comparing treatments, is there newer evidence or updated guidance from these findings that would influence whether leflunomide is still the right choice for me compared to other options?
5If some doctors in Saudi Arabia were found not to be fully following the 2022 safety counseling guidelines for leflunomide, how can I make sure that the monitoring and counseling I receive meets those recommended safety standards?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022
Timeframe: 7 months
2
Number of healthcare professionals aware of the information reported in the educational materials and additional risk minimization measures material distributed in 2022
Timeframe: 7 months
3
Number of healthcare professionals reported counseling their patients and conducting the needed laboratory investigations according to 2022 additional risk minimization measures material