A Prospective Multi-centric Belgian Trial to Validate the Use of Golimumab Serum Level Analysis Using the Dried Blood Spot (DBS) Methodology
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Comparison of golimumab serum sample through venous puncture and dried blood spot analysis
研究概览
简要总结
This retrospective multi-centric Belgian prospective trial will involve 10 patients initiating or under maintenance subcutaneous golimumab therapy for moderate-to-severe colitis at the University Hospitals Leuven (Leuven, Belgium) or AZ Groeninge (Kortrijk, Belgium)
Patients will (have) receive(d) standard induction therapy with golimumab 200mg at week 0, and golimumab 100mg at week 2. Maintenance therapy will (have) start(ed) at week 6, with 50 or 100mg of golimumab every 4 weeks, depending on body weight (50mg every 4 weeks for patients with a body weight of less than 80kg, and 100mg for the others)
Patients will come to the hospital for clinical evaluation, blood sampling and golimumab administration following daily clinical practice. The patients will be requested to perform several dry blood spot analyses at home.
详细描述
BLOOD SAMPLING:
Blood samples are collected using two sampling methods at different time points (indicated on the timeline above); DBS sampling (max 39 samples/patient) and venous blood sampling (max 13 samples/patient). Venous blood sampling will be performed during a standard outpatient clinic in one of the participating centres, and forwarded to the Laboratory for Therapeutic and Diagnostic Antibodies in Leuven for further analyses. DBS samples will be send directly to the Laboratory for Therapeutic and Diagnostic Antibodies in Leuven through classical mailing.
DBS sampling will be performed by the patient during the outpatient clinic (at same moment as venous punctures, max 13 samples/patient) and at home for the intermediate values (max 26 samples/patient). Patients will be taught how to perform a finger prick during the outpatient clinic. A conversion factor will be defined. Determination of concentration-time profile and exposure of golimumab in the individual patients will be performed by intensive sampling for 3 to 4.5 months. Time point of max concentration, intermediate concentration, and trough concentration will be determined in each patient.
Note: A similar procedure will be adopted to measure free anti-golimumab antibody concentrations on the DBS using a drug sensitive assay. Free anti-golimumab antibody concentrations will be measured when the serum golimumab concentration is below limit of quantification.
MEASUREMENT OF GOLIMUMAB AND ANTI-GOLIMUMAB ANTIBODY CONCENTRATIONS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age at least 18 at moment of inclusion
- •Established diagnosis of ulcerative colitis (UC)
- •Patients under golimumab therapy for moderate-to-severe colitis, including minimally 3 patients who will initiate golimumab therapy
排除标准
- •Subjects with Crohn's disease, or IBD type unclassified
- •Subjects who underwent a subtotal colectomy or proctocolectomy
研究组 & 干预措施
Cohort A
Patients starting golimumab therapy Week 0: 200 mg Week 2: 100 mg Week 6, 10, 14, and 18: 50 mg (<80 kg) or 100mg (>80 kg body weight)
干预措施: Cohort A (Other)
Cohort B
Patients already on golimumab therapy will continue their actual treatment 50 mg every 4 weeks (<80 kg) or 100mg every 4 weeks (>80 kg body weight)
干预措施: Cohort B (Other)
结局指标
主要结局
Comparison of golimumab serum sample through venous puncture and dried blood spot analysis
时间窗: During 4.5 months for golimumab starters and 3.0 months for patients under golimumab maintenance therapy
The primary objective of this prospective multi-centric Belgian trial is to compare golimumab serum concentrations obtained using venous puncture, with golimumab serum concentrations obtained using DBS sampling and extraction, and to determine its robustness
次要结局
- Patient perception question 3: With the provided tools it was easy to get a blood spot on the paper.(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)
- Patient perception question 4: With the provided tools it was easy to send/bring the paper with the dried blood spot to the physician/lab(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)
- Patient perception question 5: I prefer to perform the dried blood spot at home than to go to the hospital for venous sampling(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)
- Maximum golimumab serum concentration during maintenance therapy(3.0 months)
- Area under the curve of golimumab exposure during induction therapy(1.5 months)
- Area under the curve of golimumab exposure during maintenance therapy(3.0 months)
- Maximum golimumab serum concentration during induction therapy(1.5 months)
- Patient perception question 1: The information I received from my physician and colleagues regarding dried blood spot analyses was adequate(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)
- Patient perception question 2: I had fluent access to further information on all aspects of the dried blood spot analysis(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)
- Patient perception question 6: In general this dried blood spot system is user friendly(After 4.5 months for golimumab starters and after 3.0 months for patients under golimumab maintenance therapy)