Evaluation of the Effectiveness of Implementation of Additional Risk Minimization Measures (aRMM) Materials for Xeljanz® (Tofacitinib) / Rheumatoid Arthritis (RA) indication in Nigeria via a Survey among Prescribers: A Non-Interventional Post Authorization Safety Study (PASS).

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000900
• Study ID:
  1000000900
• Official title and acronym:
  Evaluation of the Effectiveness of Implementation of Additional Risk Minimization Measures (aRMM) Materials for Xeljanz® (Tofacitinib) / Rheumatoid Arthritis (RA) indication in Nigeria via a Survey among Prescribers: A Non-Interventional Post Authorization Safety Study (PASS).
• DARWIN EU® study:
  No
• Study countries:
  Nigeria
• Study description:
  This study is a regulatory, non‑interventional post‑authorisation safety study (PASS) designed to evaluate the effectiveness of additional risk‑minimisation measures (aRMMs) implemented for Xeljanz® (tofacitinib) for the treatment of rheumatoid arthritis in Nigeria, as requested by the National Agency for Food and Drug Administration and Control (NAFDAC). The study assesses whether implementation of the Xeljanz® aRMM materials (including the Prescriber Brochure, Prescriber Treatment Maintenance Checklist, and Patient Alert Card) results in prescriber behaviours and clinical decision‑making practices aligned with approved risk‑minimisation recommendations that are expected to reduce identified and potential safety risks.; This is a cross‑sectional, non‑interventional survey conducted among physicians authorised to prescribe Xeljanz® who have received the aRMM materials. The study includes physicians who have prescribed Xeljanz® as well as those who have not yet prescribed the product, reflecting the low utilisation setting and the preventive intent of the risk‑minimisation programme. Data are collected through a structured, paper‑based questionnaire administered in outpatient clinical settings across Nigeria, with no patient‑level data collected.; Primary outcomes assess prescriber implementation of risk‑minimisation behaviours, including screening and risk assessment prior to treatment initiation, application of decision rules in high‑risk clinical scenarios, and preventive counselling and Patient Alert Card use. Secondary outcomes include prescriber awareness (receipt) and utilisation of aRMM materials and knowledge of key contraindications and safety risks. Predefined effectiveness thresholds are applied to support transparent interpretation of findings. All analyses are descriptive and conducted at the prescriber level.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:06/02/2026

Actual:24/03/2026

Study start date

Planned:30/06/2026

Date of final study report

Planned:31/01/2027

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable