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Clinical Research Coordinator Analysis

Screening Procedures & Participant Eligibility

Finding: The protocol (Section 7.5.3.4, Page 45) stipulates that for participants with a positive QuantiFERON-TB Gold Plus (QFT-Plus) test at screening (and active TB ruled out), "Prophylactic treatment for latent TB infection (LTBI) *should* be administered according to local guidelines." The use of the term "should" instead of "must" or "is required" introduces ambiguity regarding eligibility if a participant, who otherwise qualifies, either refuses recommended LTBI treatment or if local guidelines offer it as a strong recommendation rather than an absolute prerequisite before starting biologic therapy. This could lead to inconsistent enrollment decisions across sites or delays while seeking sponsor clarification. Recommendation: The protocol or a supplementary guidance document (e.g., Study Operations Manual or FAQ) should explicitly clarify whether initiation of LTBI prophylactic treatment (in cases of a positive QFT-Plus with active TB excluded, and where local guidelines recommend such treatment) is a mandatory prerequisite for randomization and receiving the first dose of Investigational Product. It should also specify the eligibility status of a participant who declines recommended LTBI treatment. For instance: "Participants with confirmed LTBI (active TB ruled out) for whom prophylactic treatment is recommended per local guidelines must initiate such treatment prior to randomization. Participants unwilling to initiate recommended LTBI treatment are not eligible for the study." Rationale: This clarification will ensure consistent interpretation and application of this eligibility criterion across all participating sites, prevent potential enrollment of ineligible participants, reduce site queries related to this specific scenario, and streamline the screening and enrollment process, thereby aiding in predictable operational planning.