National Post-market Clinical Follow-up Study to Evaluate in Real-world Practice the Efficacy and Safety of Granulocytoapheresis and Its Impact on Quality of Life in Patients with Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 30
- 主要终点
- Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy
研究概览
简要总结
Inflammatory bowel disease (IBD) encompasses several chronic diseases of which ulcerative colitis (UC) and Crohn's disease (CD) are the most representative. IBD is characterised by the presence of an inflammatory process that affects different segments of the digestive tract and has a chronic and relapsing course with flares of activity.
Inflammatory activity in IBD is associated with an increase in peripheral blood activated granulocytes and monocyte-macrophages and intestinal infiltration by these inflammatory cells, which are largely responsible for tissue damage. In recent years, observational, prospective studies and meta-analyses of these studies have contributed to consider granulocytapheresis (GMA) as an effective and safe alternative in the treatment of UC.
This apheresis technique is based on recirculation of the patient's blood through a circuit with cellulose acetate spheres that perform a selective elimination of granulocytes and monocyte-macrophages leading to a reduction in pro-inflammatory cytokines and adhesion molecule expression, and an increase in anti-inflammatory mediators. These events in the GMA column are followed by other immunological changes, most notably a decrease in CD10+ (activated) neutrophils, leading to a compensation from the bone marrow of a CD10- (immature) neutrophil population.
GMA can be considered as a therapeutic alternative in corticodependent IBD, especially in UC. In addition, it can reduce or limit the need for corticosteroids, so another possible application is as a "bridge" treatment in patients starting treatment with thiopurine immunomodulators. A beneficial effect can also be obtained by combining apheresis with biological treatments, especially after a partial response or loss of response to these treatments. Finally, some extraintestinal manifestations associated with IBD may also benefit from its use.
The GRACE study is proposed for the evaluation of the efficacy of GMA with Adacolumn® under real conditions of use and according to the indications described in the instructions for use of the medical device.
详细描述
It is planned to enrol a minimum of 350 patients from approximately 30 sites. To avoid screening biases, the patients to be included per site will be selected consecutively from among those who meet the eligibility criteria to participate in the study.
A national, multicentre, noninterventional post-market clinical follow-up (PMCF) study with an estimated follow-up period of 12 months after completion of GMA therapy to evaluate the efficacy of Adacolumn® GMA in actual conditions of use, as specified in the product instructions for use, in adult patients diagnosed with UC or CD. Approximately 350 patients from about 30 centres in Spain are planned to be included.
The standard regimen according to product instructions for use is one session per week for 5 consecutive weeks, although in specific cases continuous regimens have been established for maintenance (one or two sessions per month) or others for induction (two sessions per week). The use of a higher number of sessions seems to increase efficacy from 40% with 5 sessions to 80% with 10 in the more refractory cases and may achieve a greater reduction in steroid use. In Europe, where GMA is used in different scenarios, it is routinely being used in 7 to 10 sessions.
The study will consist of a maximum of 4 visits: a baseline visit, which will coincide with patient inclusion in the study, and 3 follow-up visits at 4 (±2 weeks) (month 1), 24 (±2 weeks) (month 6) and 48 (±2 weeks) (month 12) weeks after the last session of induction apheresis.
All visits scheduled during the study will coincide with any of the patient visits made as part of routine clinical follow-up, without interfering with the investigator's clinical duties. Note: In the event that a patient discontinues Adacolumn® GMA, the reasons for discontinuation of the procedure will be recorded and the change in treatment for IBD, if any.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Established diagnosis of UC or CD according to ECCO criteria.
- •Patients in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study.
- •Patients who understand and voluntarily sign informed consent.
排除标准
- •Patient with any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
- •Patient who is participating in a clinical trial.
- •NOTE: If the physician knows or suspects that the patient is unable to understand the implications of his/her participation in the study, the patient should not enter without the signature of his/her legal representative
结局指标
主要结局
Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy
时间窗: 6 months
Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy. Clinical remission is defined as: 1. For Ulcerative Colitis: Total Mayo score ≤2, with no subscore \>1 and rectal bleeding subscore of 0. 2. For Crohn´s Disease: Harvey-Bradshaw Index score ≤4. Mayor score (0-12). Higher scores mean a worse outcome. Harvey-Bradshaw Index (0-undetermined). Higher scores mean a worse outcome.
次要结局
- Define the regimens used for GMA in actual clinical practice.(12 months)
- Sustained clinical remission rate(12 months)
- Rate of patients requiring steroids and mean dose during follow-up(12 months)
- Changes in faecal calprotectin and C-reactive protein (CRP) biomarkers during treatment(12 months)
- 6- and 12-month clinical response rates(6 and 12-month)
- 6- and 12-month remission rates completion of GMA therapy(6 and 12-month)
- Change in patients' quality of life(6 months)
- Rate of patients receiving GMA as maintenance and its efficacy(12 months)
- Early clinical remission rate(1 month)
- Rate of treatment-related adverse events (AEs) and seriousness(6 months)
- Number of patients requiring surgery(6 months)