An observational study in Rheumatoid Arthritis and Psoriatic Arthritis, sponsored by Sanofi. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Sanofi · Observational
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.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's enrollment of 302 is above the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Participants are healthcare professionals in Saudi Arabia completing a survey regarding experience prescribing/managing/dispensing leflunomide
Drug: Leflunomide
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Also known as: ARAVA®
Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022
Time frame: 7 months
Number of healthcare professionals aware of the information reported in the educational materials and additional risk minimization measures material distributed in 2022
Time frame: 7 months
Number of healthcare professionals reported counseling their patients and conducting the needed laboratory investigations according to 2022 additional risk minimization measures material
Time frame: 7 months
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi