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

Sanofi

Status: Begins enrollment this month

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Drug: Leflunomide

Study type: Observational

Funder types: Industry

Identifiers

NCT06714461

U1111-1311-1317 (Registry Identifier)

OBS18508

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,500 participants in 1 patient group

Leflunomide

Description:

Participants are healthcare professionals in Saudi Arabia completing a survey regarding experience prescribing/managing/dispensing leflunomide

Treatment:

Drug: Leflunomide