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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design, other:
  This study is designed as a cross-sectional, non-interventional survey targeting Health Care Professionals (“HCPs”) specializing in Rheumatology, Internal Medicine, and other relevant disciplines who have been identified by Pfizer as prescribers of Xeljanz®. The survey will be distributed in paper format and the completed questionnaire collected via face-to-face meetings with HCPs. Data from these completed questionnaires will be transcribed into a web platform for subsequent analysis.

Study drug and medical condition

• Medicinal product name:
  XELJANZ
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AF01) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The study population is limited to physicians authorised to prescribe Xeljanz® who have received the additional risk-minimisation measure (aRMM) materials. ; Therefore, the study population consists of Rheumatologists and other prescribers of Xeljanz® ; in Nigeria, (e.g. Internists).

Study design details

• Study design:
  Non-interventional cross-sectional survey
• Main study objective:
  The primary objective of this study is: ; To evaluate whether implementation of the Xeljanz® aRMM materials (Patient Alert Card, Prescriber Brochure, and Prescriber Treatment Maintenance Checklist) in Nigeria results in prescriber risk‑mitigation behaviours and decision‑making practices that are expected to reduce identified and potential safety risks associated with Xeljanz® use in RA (including serious infections/TB, malignancy/NMSC, VTE, MACE, and laboratory abnormalities).; ; Secondary objectives: ; • Evaluate prescriber awareness (receipt) and utilisation of each aRMM component. ; • Evaluate prescriber knowledge and comprehension of key contraindications, risks, and risk‑minimisation instructions. ; • Describe prescriber practice characteristics and barriers/facilitators to implementation. ; • Explore descriptive associations between receipt/knowledge and implementation of ; risk‑mitigation behaviours.
• Setting:
  This study will be conducted in Nigeria and will involve a non-interventional, cross-sectional survey of Physicians practising in outpatient clinical settings, including public and private healthcare facilities. The study will not involve direct patient contact, clinical interventions, or collection of patient-level data.
• Outcomes:
  Primary outcomes assess prescriber implementation of risk minimisation behaviours and clinical decision-making practices aligned with aRMM recommendations, including screening, risk assessment, decision-rule application, preventive counselling and Patient Alert Card use. These outcomes will be measured using prescriber responses to predefined behaviour-based and clinical scenario-based questions in a structured, paper-based questionnaire administered face to face, with responses classified according to prespecified criteria aligned with approved aRMM recommendations. ; Secondary outcomes include prescriber awareness (receipt) and utilisation of aRMM materials and knowledge of key contraindications and safety risks, measured through structured questionnaire items assessing recall, use, and correct responses to predefined knowledge questions. Key covariates include prescriber professional background and practice characteristics (e.g., specialty, years of practice, practice setting), experience with Xeljanz®, and perceived barriers to implementation of aRMM recommendations, collected via self-reported questionnaire data.
• Data analysis plan:
  All analyses will be descriptive and conducted at the prescriber level, which is the unit of assessment for this study. Categorical variables will be summarised using frequencies and proportions, and continuous variables will be summarised using mean, standard deviation, median, range, and interquartile range (IQR), as appropriate. ; Analyses are structured to correspond directly to the study objectives and the variables defined in Section 9.3, and to the questionnaire sections provided in Annex 1. ; Given the descriptive, threshold-based nature of the analysis and the number of prescribers exposed to the additional risk-minimisation measure (aRMM) materials, the proposed sample size is sufficient to determine whether predefined adequacy thresholds for awareness, knowledge, and implementation of risk-minimisation behaviours are met, without reliance on formal hypothesis testing. ; Detailed methodology for summary and statistical analyses of data collected in this study will be documented in a statistical analysis plan (SAP), which will be dated, filed, and maintained by the sponsor. The SAP may modify the plans outlined in the protocol; any major modifications of primary endpoint definitions or their analyses would be reflected in a protocol amendment.