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

NCT06714461 | Active Not Recruiting FDA Drug

• 2 other identifiers: OBS18508U1111-1311-1317
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Leflunomide

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

Drug: Leflunomide

Interventions

Leflunomide DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.

Also known as: ARAVA®

Leflunomide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthcare professionals working only in Saudi Arabia
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Chilly-Mazarin, 91380, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)