A Post-Marketing Surveillance Study on the Safety and Effectiveness of Golimumab (Simponi) Among Adult Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with incidence of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
详细描述
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) to evaluate the safety and effectiveness of golimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis among Filipino patients.
The study will enroll approximately 50 patients who would use golimumab with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored from baseline and every 4 weeks thereafter for a period of 24 weeks. Safety evaluations for adverse events, clinical laboratory tests, physical examination, concomitant medications, and co-morbid conditions will be monitored throughout the study. The total study will be conducted for 3 years and duration of treatment will be for 24 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Have rheumatoid arthritis and exhibit at least four of the following criteria: morning stiffness for at least one hour and present for at least six weeks, swelling of three or more joints for at least six weeks, swelling of wrist, metacarpophalangeal or proximal interphalangeal joints for six or more weeks, symmetrical joint swelling, X-ray changes of hand that include erosions or unequivocal bony decalcification, rheumatoid nodules, serum rheumatoid factor by a method positive in less than 5 percent of normal
- •Have ankylosing spondylitis and must have either of the following: Grade 3-4 sacroiliitis with at least one clinical criterion, Grade 3-4 unilateral sacroiliitis, Grade 2 bilateral sacroiliitis with clinical criterion 1 (limitation of motion of the lumbar spine in all 3 planes: anterior flexion, lateral flexion, extension) or criterion 2 (history of pain in the lumbar spine or at the dorso-lumbar junction) and criterion 3 (limited chest expansion to 2.5 cm or less, measured at the fourth intercostals line)
- •Have psoriatic arthritis and includes 3 of the following conditions: an inflammatory arthritis (peripheral arthritis and/or sacroiliitis or spondylitis), the presence of psoriasis, the (usual) absence of serological tests for rheumatoid factor
排除标准
- •Known hypersensitivity to golimumab or to any of the components of the agent preparation
- •Pregnant or breastfeeding females
- •Not agreeing to protocol-defined use of effective contraception
- •Patients receiving live vaccines while on treatment
- •Patients with documented clinically important, active infection (eg, active tuberculosis infection)
- •Patients with documented past and current history of malignancy and significant cytopenias (reduction in the number of blood cells)
研究组 & 干预措施
Golimumab
Patients will be taking golimumab as per the dosing regimen given on product insert approved in Philippines.
干预措施: No intervention (Drug)
结局指标
主要结局
Number of patients with incidence of adverse events
时间窗: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
Number of patients with incidence of discontinuation of study medication due to adverse events
时间窗: From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
次要结局
- Number of patients who would show improvement using the Health Assessment Questionnaire (HAQ) Score(Baseline, Weeks 4, 8, 12, 16, 20, and 24)