NCT02679001已完成不适用
A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Percentage of participants with a decrease in dose of oral corticosteroids during the study
研究概览
简要总结
This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •At least 18 years of age.
- •With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
- •Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
- •The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
- •Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.
排除标准
- •Have had more than one TNF-inhibitor prior to the enrolment visit.
- •Have had biological treatment other than TNF-inhibitors.
- •Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).
研究组 & 干预措施
RA participants treated with a TNF inhibitor or TCZ
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.
干预措施: TNF inhibitor/TCZ (Drug)
结局指标
主要结局
Percentage of participants with a decrease in dose of oral corticosteroids during the study
时间窗: From baseline to 6 months
次要结局
- Percentage of participants achieving C59CDAI remission (</=2.8)(From baseline to 6 months)
- Percentage of participants achieving CDAI LDA (</=10)(From baseline to 6 months)
- Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period(Baseline, Month 6)
- Percentage of participants with dose change in biological treatment during study(From baseline to 6 months)
- Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline(From baseline to 6 months)
- Cumulated doses of oral corticosteroids during study period(From baseline to 6 months)
- Mean change from baseline to end of study in EULAR response(Baseline, Month 6)
- Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study(From baseline to 6 months)
- Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections(From baseline to 6 months)
- Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score(Baseline, Month 6)
- Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)(Baseline, Month 6)
- Mean change from baseline to end of study in Severity of pain (VAS scale)(Baseline, Month 6)
- Percentage of participants for whom non-biologic DMARDs was added during observation period(From baseline to 6 months)
- Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections(From baseline to 6 months)
- Mean change from baseline to end of study in swollen 28 joint count(Baseline, Month 6)
- Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline, Month 6)
- Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)(From baseline to 6 months)
- Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study(From baseline to 6 months)
- Mean dose of corticosteroids at start and end of study(From baseline to 6 months)
- Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score(Baseline, Month 6)
- Mean change from baseline to end of study in tender 28 joint count(Baseline, Month 6)
- Percentage of participants who started or stopped oral corticosteroid treatment during the study period(From baseline to 6 months)
- Mean change from baseline to end of study of corticosteroids(Baseline, Month 6)
- Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)(Baseline, Month 6)
- Cumulated doses of all corticosteroids during study period(From baseline to 6 months)
- Mean change from baseline to end of study in crohns disease activity index (CDAI) score(Baseline, Month 6)
- Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)(From baseline to 6 months)
研究者
研究点 (11)
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