Available IPD datapackage for study 'A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis'

The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

本研究旨在评估戈利木单抗（golimumab）皮下注射（即注射于皮下组织）治疗活动性强直性脊柱炎（ankylosing spondylitis，AS，又称脊柱关节炎）的安全性与有效性。有效性将以活动性AS的体征与症状缓解程度作为核心评估指标，具体涵盖背痛与脊柱僵硬症状改善、躯体功能恢复、脊柱活动度提升、生活质量改善，以及X光（X-ray）影像下脊柱损伤或融合的发生率变化。