NCT06714461Completed
A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
Post Authorization Safety Study on Assessment of Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 302 (actual)
- First submitted
- 27 Nov 2024
- Start date
- 5 May 2025
- Primary completion date
- 14 May 2026
- Lead sponsor
- Sanofi
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT06714461
What you commit to
- Study type: Observational
- Participants enrolled: 302
- From 5 May 2025 to the primary completion date, 14 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Healthcare professionals (with a relative) involved in leflunomide -related lawsuits or associations for victims of leflunomide syndrome
Other
- Healthcare professionals who may have conflicts of interest with the survey (i.e., employed by regulatory bodies or pharmaceutical companies)
- Healthcare professionals who are not prescribing leflunomide
Who the study is looking for
- 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
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanofi-Aventis Coordinator of this site? Confirm its status | Chilly-Mazarin | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.