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A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia

CompletedN/A

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis, Psoriatic Arthritis

Interventions: Leflunomide

Countries: France

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.

Eligibility overview

Sex: ALL

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Chilly-Mazarin, France