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

NCT05636709 | Recruiting

• 1 other identifier: GRACE
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  6 months

Secondary Outcomes (11)

• Define the regimens used for GMA in actual clinical practice.

  12 months

• Early clinical remission rate

  1 month

• 6- and 12-month remission rates completion of GMA therapy

  6 and 12-month

• Sustained clinical remission rate

  12 months

• 6- and 12-month clinical response rates

  6 and 12-month

Interventions

Adacolumn DEVICE

Non interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Ulcerosis Colitis or Crohn disease from about 30 centres in Spain in whom the physician in charge of treatment decides to start treatment with GMA and independently of their inclusion in the study.

You may qualify if:

• ≥18 years.
• Established diagnosis of UC or CD according to ECCO criteria.
• Patients who understand and voluntarily sign informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Adacyte Therapeutics SL: lead

Study Sites (30)

H. Albacete

Albacete, Albacete, 02006, Spain

RECRUITING

H. General de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

H. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

H. Vall d´hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

H. Galdakao

Galdakao, Bizkaia, 48960, Spain

RECRUITING

H. General de Castellón

Castellon, Castellón, 12004, Spain

RECRUITING

H. Puerta del Mar

Cadiz, Cádiz, 11009, Spain

RECRUITING

H. Reina Sofía

Córdoba, Córdoba, 14004, Spain

RECRUITING

H. Donostia

San Sebastián, Gipuzkoa, 20014, Spain

RECRUITING

H. Virgen de las Nieves

Granada, Granada, 18014, Spain

RECRUITING

H. Guadalajara

Guadalajara, Guadalajara, 19002, Spain

RECRUITING

H. San Jorge

Huesca, Huesca, 22004, Spain

RECRUITING

H. Santiago

Santiago de Compostela, La Coruña, 15706, Spain

RECRUITING

H. San Pedro

Logroño, La Rioja, 98, Spain

RECRUITING

H. Dr. Negrín

Las Palmas de Gran Canaria, Las Palmas de Gran Canarias, 35010, Spain

RECRUITING

H. 12 de octubre

Madrid, Madrid, 28041, Spain

RECRUITING

H. La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

H. Costa del Sol

Marbella, Málaga, 29603, Spain

RECRUITING

H. Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

H. Río Carrión

Palencia, Palencia, 34005, Spain

RECRUITING

H. Son Espases

Palma de Mallorca, Palma de Mallorca, 07120, Spain

RECRUITING

H. Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

RECRUITING

H. Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

H. Univ. de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

H. Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

RECRUITING

H. Virgen del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

H. Clínico Univ. de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

H. General de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

H. La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

H. Virgen de la Concha

Zamora, Zamora, 49022, Spain

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Jose Luis Cabriada

  H. Galdakao

  STUDY CHAIR

• Iago Rodríguez

  H. Galdakao

  STUDY CHAIR

• Daniel Ginard

  H. Son Espases

  STUDY CHAIR

Central Study Contacts

Mercedes Benavente

CONTACT

+34680190948; m.benavente@evidenze.com

Pablo Zapico

CONTACT

+ 34687975712; p.zapico@adacyte.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: December 5, 2022
• Study Start: January 11, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (30)