Efficacy and Safety of Targeted Therapeutic Strategies in Adults with Rheumatoid Arthritis: A Randomized, Double‑Blind, Placebo‑Controlled Study

The trial enrolled a total of 11 participants diagnosed with Rheumatoid Arthritis. Both female and male subjects were included, spanning the age categories represented by codes 3 and 4, corresponding to adults aged 18 years and older, including those 65 years and older. All participants were classified as patients with the target condition and were selected on the basis of a confirmed diagnosis of the disease. General health status was limited to the presence of the rheumatologic condition; no additional health or lifestyle requirements such as specific diet, physical activity level, or smoking status were reported. Key inclusion criteria required a documented diagnosis of the condition, while exclusion criteria were not detailed in the provided information.

The study is a Phase 3, multicenter trial evaluating targeted therapies in patients with Rheumatoid Arthritis. The design is randomized, double-blind and controlled, with participants allocated to active treatment or placebo arms. Recruitment is planned to begin on 21 October 2026 and the study is scheduled to conclude on 25 January 2029, resulting in an overall trial duration of approximately 27 months. After an initial screening visit to confirm eligibility, participants will attend baseline assessments followed by scheduled follow‑up visits at regular intervals (e.g., weeks 4, 12, 24, 48, and 72) to monitor safety, efficacy, and pharmacokinetic parameters. The final visit, designated as the end‑of‑study assessment, occurs at the completion of the treatment period. Individual involvement is expected to last the full treatment phase, roughly 24 months, with additional follow‑up as required. Early termination may occur if a participant experiences a serious adverse event, fails to meet protocol compliance, withdraws consent, or if interim analyses indicate insufficient efficacy or safety concerns.