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临床试验/NCT01313858
NCT01313858已完成不适用

Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

Merck Sharp & Dohme LLC0 个研究点目标入组 1,613 人开始时间: 2010年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,613
主要终点
Clinical Global Impression (CGI) Disease Status

研究概览

简要总结

This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.

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

入选标准

  • Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time

排除标准

  • No specific exclusion criteria

研究组 & 干预措施

Participants with Rheumatoid Arthritis

Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.

干预措施: Simponi® (Drug)

Participants with Rheumatoid Arthritis

Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.

干预措施: Methotrexate (Drug)

Participants with Psoriatic Arthritis

Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.

干预措施: Simponi® (Drug)

Participants with Ankylosing Spondylitis

Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.

干预措施: Simponi® (Drug)

结局指标

主要结局

Clinical Global Impression (CGI) Disease Status

时间窗: Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24

The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to "10" (strong discomfort). The closer the score to 0, the better the health status.

Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score

时间窗: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24

The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH\[%\] = (Attained score\*100)/(2\*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score

时间窗: Baseline and Months 3, 6, 12, 18, 24

The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.

Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score

时间窗: Baseline and Months 6, 12, 18, 24

The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.

Number of Participants Who Experienced at Least One Adverse Event

时间窗: Up to 24 months

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

Number of Participants Who Experienced at Least One Serious Adverse Event

时间窗: Up to 24 months

A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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