NCT02534311已完成不适用
Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level
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
- 60
- 主要终点
- Average change from baseline in DAS28
研究概览
简要总结
The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Participants with age greater than or equal to (>=) 18 years
- •Participants with moderate to severe active RA (DAS28 >=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (DMARDs), irrespective of whether they were of biological or synthetic nature
- •Participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (SPC) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for RA in the past either
- •Assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient.
- •Pulmonologist's consent for chest X-ray and quantiferon test with commencement of biological treatment
排除标准
- •Hepatitis B surface antigen (HBsAg,) hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positivity
- •History of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies
- •History of intestinal ulcerations or diverticulitis
- •Active hepatopathy with more than threefold increase of alanine transaminase (ALT) or aspartate transaminase (AST)
- •Thrombocytes <100,000 per cubic milliliters (/mm^3), less than (<) 3,000 mm^3, absolute neutrophil count < 2,000 mm^3
- •Women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)
研究组 & 干预措施
Tocilizumab
Participants will receive tocilizumab (162 milligrams [mg]) SC injection for 48 weeks.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Average change from baseline in DAS28
时间窗: up to Week 48
次要结局
- Percent of participants achieving clinical remission defined as a DAS28 <2.6(Baseline, Week 12, 24, 36, and 48)
- Percentage of participants achieving a DAS28 >=3.2(Baseline, Week 12, 24, 36, and 48)
- Evaluation of participant's pain using visual analogue scale (VAS)(Baseline, Week 12, 24, 36, and 48)
- Evaluation of the disease activity by participant using VAS(Baseline, Week 12, 24, 36, and 48)
- Evaluation of the disease activity by Doctor using VAS(Baseline, Week 12, 24, 36, and 48)
- DAS28-joint count (erythrocyte sedimentation rate) [DAS28(ESR)] score(Baseline, Week 12, 24, 36, and 48)
- Absolute and percent change in the Health Assessment Questionnaire (HAQ)(Baseline, Week 12, 24, 36, and 48)
- DAS28-joint count (C-reactive protein) [DAS28(CRP)] score(Baseline, Week 12, 24, 36, and 48)
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