Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGLeflunomide
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed