A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
NCT ID: NCT06714461
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
3500 participants
OBSERVATIONAL
2025-05-05
2025-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Leflunomide
Participants are healthcare professionals in Saudi Arabia completing a survey regarding experience prescribing/managing/dispensing leflunomide
Leflunomide
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Interventions
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Leflunomide
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 (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.
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Sanofi-Aventis
Chilly-Mazarin, , France
Countries
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Other Identifiers
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U1111-1311-1317
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS18508
Identifier Type: -
Identifier Source: org_study_id
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