Clinical trial NCT06714461: A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
Official title: Post Authorization Safety Study on Assessment of Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this survey-based study, the data will be collected from each healthcare professional participant in Saudi Arabia once at a certain time. However, the study will take 7 months, from 30 November 2024 to 30 May 2025, to collect the required number of responses.

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.


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.

Primary outcomes:
measure: Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022
timeFrame: 7 months
measure: 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
measure: Number of healthcare professionals reported counseling their patients and conducting the needed laboratory investigations according to 2022 additional risk minimization measures material
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chilly-Mazarin
country: France
facility: Sanofi-Aventis
Study officials:
References: