Ulcerative Colitis Clinical Trial
— GRACEOfficial title:
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
NCT number | NCT05636709 |
Other study ID # | GRACE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 11, 2022 |
Est. completion date | December 31, 2025 |
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.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | December 31, 2025 |
Est. primary completion date | January 10, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =18 years. 2. Established diagnosis of UC or CD according to ECCO criteria. 3. Patients in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study. 4. Patients who understand and voluntarily sign informed consent. Exclusion Criteria: 1. 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. 2. 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 |
Country | Name | City | State |
---|---|---|---|
Spain | H. Albacete | Albacete | |
Spain | H. General de Alicante | Alicante | |
Spain | H. Germans Trias i Pujol | Badalona | Barcelona |
Spain | H. Vall d´hebron | Barcelona | |
Spain | H. Puerta del Mar | Cádiz | |
Spain | H. General de Castellón | Castelló de la Plana | Castellón |
Spain | H. Reina Sofía | Córdoba | |
Spain | H. Galdakao | Galdakao | Bizkaia |
Spain | H. Virgen de las Nieves | Granada | |
Spain | H. Guadalajara | Guadalajara | |
Spain | H. San Jorge | Huesca | |
Spain | H. Univ. de Canarias | La Laguna | Santa Cruz De Tenerife |
Spain | H. Dr. Negrín | Las Palmas De Gran Canaria | Las Palmas De Gran Canarias |
Spain | H. San Pedro | Logroño | La Rioja |
Spain | H. 12 de octubre | Madrid | |
Spain | H. La Paz | Madrid | |
Spain | H. Costa del Sol | Marbella | Málaga |
Spain | H. Río Carrión | Palencia | |
Spain | H. Son Espases | Palma De Mallorca | |
Spain | H. Son Llatzer | Palma de Mallorca | |
Spain | H. Navarra | Pamplona | Navarra |
Spain | H. Donostia | San Sebastián | Gipuzkoa |
Spain | H. Ntra. Sra. de Candelaria | Santa Cruz De Tenerife | |
Spain | H. Santiago | Santiago De Compostela | La Coruña |
Spain | H. Virgen del Rocío | Sevilla | |
Spain | H. Clínico Univ. de Valencia | Valencia | |
Spain | H. General de Valencia | Valencia | |
Spain | H. La Fe | Valencia | |
Spain | H. Álvaro Cunqueiro | Vigo | Pontevedra |
Spain | H. Virgen de la Concha | Zamora |
Lead Sponsor | Collaborator |
---|---|
Adacyte Therapeutics SL |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy | Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy. Clinical remission is defined as:
For Ulcerative Colitis: Total Mayo score =2, with no subscore >1 and rectal bleeding subscore of 0. 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. |
6 months | |
Secondary | Define the regimens used for GMA in actual clinical practice. | The strategies for use of GMA will be evaluated by the following:
Frequency of GMA sessions, Number of sessions, Blood volume processed per session in ml, Length of sessions in minutes, Method of administration of the technique (peripheral access or central catheter), Type of anticoagulant (Heparin, sodic heparin, low molecular weight heparin), Dose of anticoagulant (ml), Form of administration (infusion or bolus). Proportion of patients receiving GMA treatment combined with biologics or immunosuppressants as bridge treatment after instituting treatment with immunomodulators due to lack of response or intolerance to immunosuppressants and/or biologics or as an alternative to conventional treatment. Proportion of patients with steroid-dependent or steroid-refractory disease receiving GMA. Proportion of patients receiving GMA as treatment for remission induction or relapse prevention. Proportion of patients receiving GMA as maintenance treatment |
12 months | |
Secondary | Early clinical remission rate | Proportion of patients achieving steroid-free clinical remission at 1 month after completion of GMA therapy
Clinical remission is defined as: For Ulcerative Colitis: Total Mayo score =2, with no subscore >1 and rectal bleeding subscore of 0. 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. |
1 month | |
Secondary | 6- and 12-month remission rates completion of GMA therapy | Proportion of patients achieving steroid-free clinical remission at 12 months after completion of GMA therapy
Clinical remission is defined as: For Ulcerative Colitis: Total Mayo score =2, with no subscore >1 and rectal bleeding subscore of 0. 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. |
6 and 12-month | |
Secondary | Sustained clinical remission rate | Proportion of patients maintaining clinical remission at 12 months after completion of GMA therapy
Clinical remission at 12 months is defined as: For Ulcerative Colitis: Total Mayo score =2, with no subscore >1 and rectal bleeding subscore of 0. For Crohn´s Disease: Harvey-Bradshaw Index score =4. Until 12 months Mayor score (0-12). Higher scores mean a worse outcome. Harvey-Bradshaw Index (0-undetermined). Higher scores mean a worse outcome. |
12 months | |
Secondary | 6- and 12-month clinical response rates | Proportion of patients with clinical response at 6 and 12 months after completion of GMA therapy, defined as a reduction of 3 o more points or 30% in the Mayo score for Ulcerative Colitis, or 3 or more points in the Harvey Bradshaw index for Crohn´s Disease
Mayor score (0-12) Harvey-Bradshaw Index (0-undetermined) Higher scores mean a worse outcome. |
6 and 12-month | |
Secondary | Rate of patients receiving GMA as maintenance and its efficacy | Proportion of patients on maintenance treatment remaining in steroid-free clinical remission at 6 (visit 3) and 12 (visit 4) months after completion of therapy
Clinical remission is defined as: For Ulcerative Colitis: Total Mayo score =2, with no subscore >1 and rectal bleeding subscore of 0. For Crohn´s Disease: Harvey-Bradshaw Index score =4. At 6 months and 12 months Mayor score (0-12). Higher scores mean a worse outcome. Harvey-Bradshaw Index (0-undetermined). Higher scores mean a worse outcome. |
12 months | |
Secondary | Rate of patients requiring steroids and mean dose during follow-up | Rate of patients requiring steroids
Mean dose of steroids Steroids in mg |
12 months | |
Secondary | Changes in faecal calprotectin and C-reactive protein (CRP) biomarkers during treatment | The change in biomarkers levels (faecal calprotectin (microg/g or mg/Kg) and CRP (mg/L)) will be evaluated by laboratory tests performed at the baseline visit (visit 1), at each apheresis session, at 1 month after completion of treatment (visit 2) and at 6 (visit 3) and 12 months (visit 4) after completion of treatment. | 12 months | |
Secondary | Rate of treatment-related adverse events (AEs) and seriousness | Frequency of treatment-related AEs and seriousness | 6 months | |
Secondary | Change in patients' quality of life | The change in quality of life will be evaluated by the validated version in Spanish of the Inflammatory Bowel Disease Questionnaire, which will be completed by the patient at the baseline visit (visit 1), at each apheresis session, at 1, (visit 2), 6 (visit 3) and 12 months (visit 4) after completion of treatment
Inflammatory Bowel Disease Questionnaire (0-100) Higher scores mean a better outcome. |
6 months | |
Secondary | Number of patients requiring surgery | Proportion of patients requiring surgery during the study period (UC: colectomy, segmental colonic resection, perianal; CD: small intestine resection, colonic resection, ileocecal resection, perianal resection). | 6 months |
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