A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
- Registration Number
- NCT06714461
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3500
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Leflunomide Leflunomide Participants are healthcare professionals in Saudi Arabia completing a survey regarding experience prescribing/managing/dispensing leflunomide
- Primary Outcome Measures
Name Time Method Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022 7 months Number of healthcare professionals aware of the information reported in the educational materials and additional risk minimization measures material distributed in 2022 7 months Number of healthcare professionals reported counseling their patients and conducting the needed laboratory investigations according to 2022 additional risk minimization measures material 7 months
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie leflunomide's efficacy in rheumatoid and psoriatic arthritis, and how do they inform risk minimization strategies?
How does leflunomide's safety profile compare to methotrexate in managing rheumatoid arthritis in Saudi Arabia?
Which biomarkers predict leflunomide response in patients with psoriatic arthritis, and how do they influence risk minimization measures?
What are the most common adverse events associated with leflunomide in post-authorization studies, and how do risk minimization measures mitigate them?
How do combination therapies involving leflunomide and biologic DMARDs affect risk-benefit profiles in rheumatoid arthritis management?
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Chilly-Mazarin, France