National GMA Post-market Clinical Follow-up Study (GRACE)

Condition(s) studied

Investigational drug(s) / intervention(s)

Adacolumn: Non interventional study

Study summary

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.

Eligibility

Primary outcome measure(s)

• Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy — 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.

Trial sites (30)

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