NCT02648035已完成不适用
Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
研究概览
简要总结
The purpose of this study is to evaluate the percentage of participants treated with subcutaneous (SC) Tocilizumab who are still on treatment after 52 weeks and the factors that play a major role in continuation of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >/= 18 years of age with rheumatoid arthritis (RA) for whom the treating physician has made the decision to start subcutaneous (SC) Tocilizumab (TCZ) treatment according to approved label within 4 weeks prior to enrolment.
排除标准
- •Participants who have been receiving Tocilizumab (TCZ) for more than 4 weeks prior to enrolment.
- •Participants who have received TCZ in past treatments.
- •Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) of starting treatment TCZ SC.
- •Participants with a history of autoimmune disease or of any joint inflammatory disease other than rheumatoid arthritis (RA).
结局指标
主要结局
Percentage of Participants Still Receiving Subcutaneous Tocilizumab Therapy at 52 Weeks of Observation
时间窗: At 52 weeks
次要结局
- Patient Global Assessment of Disease Activity (PtGA) Score in a 100 mm VAS Scale(At baseline, 24 and 52 weeks)
- Percentage of Participants with Clinically Significant Changes in Laboratory Values(At baseline, 24 and 52 weeks)
- Percentage of Participants with IEs with Laboratory Abnormalities(Up to 52 weeks)
- Visual Analog Scale (VAS) Pain Score in a 100 mm Scale(At baseline, 24 and 52 weeks)
- Percentage of Participants on Subcutaneous Tocilizumab Alone Versus Combination Therapy(At baseline, 24 and 52 weeks)
- Percentage of Participants with Infections Events (IEs), Including Serious and Non-Serious IEs(Up to 52 weeks)
- Percentage of Participants with Dose Modification of Methotrexate (MTX) or Other Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) Due to AEs or IEs(Up to 52 weeks)
- Percentage of Participants with Good/Moderate Response According to the Classification of the European League Against Rheumatism (EULAR)(At baseline, 24 and 52 weeks)
- Health Assessment Questionnaire (HAQ) Score(At baseline, 24 and 52 weeks)
- Percentage of Participants Involved in Subcutaneous Tocilizumab Patient Support Programs (PSPs)(At baseline, 24 and 52 weeks)
- Percentage of Participants with Adverse Events (AEs), including Serious Adverse Events (SAEs), Non-Serious Adverse Drug Reactions (nsADRs), Injection Site Reactions (ISRs), and Adverse Events of Special Interest (AESIs)(Up to 52 weeks)
- Percentage of Participants with Dose Modification of Subcutaneous Tocilizumab Due to AEs or IEs(Up to 52 weeks)
- Percentage of Participants on Glucocorticoids (GCs) with AEs(Up to 52 weeks)
- Disease Activity Score 28 (DAS28)(At baseline, 24 and 52 weeks)
研究者
研究点 (15)
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