Crohn'sUCRecruiting

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

Observational · No treatment assigned · 30 sites · Adacyte Therapeutics SL

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Crohn Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

≥18 years.
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.

Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 350 participants are expected to take part.
Start date: 2022-01-11.
Main results expected around 2026-06-30 (estimate from the record).
30 study sites listed (30 marked recruiting) in Spain.

Main thing being measured

Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy (6 months)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Crohn Disease; Ulcerative Colitis
Lead sponsor	Adacyte Therapeutics SL
Enrollment	350 (estimated)
Start date	2022-01-11
Primary completion (est.)	2026-06-30
First posted	2022-12-05
Last updated	2025-01-30
Official 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
ClinicalTrials.gov ID	NCT05636709

Interventions

Adacolumn (Device)
Non interventional study

Full eligibility criteria (from the record)

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

Locations (30)

Show all 30 sites

Site	City	Country	Site status
H. Albacete	Albacete, Albacete	Spain	Recruiting
H. General de Alicante	Alicante, Alicante	Spain	Recruiting
H. Germans Trias i Pujol	Badalona, Barcelona	Spain	Recruiting
H. Vall d´hebron	Barcelona, Barcelona	Spain	Recruiting
H. Galdakao	Galdakao, Bizkaia	Spain	Recruiting
H. General de Castellón	Castellon, Castellón	Spain	Recruiting
H. Puerta del Mar	Cadiz, Cádiz	Spain	Recruiting
H. Reina Sofía	Córdoba, Córdoba	Spain	Recruiting
H. Donostia	San Sebastián, Gipuzkoa	Spain	Recruiting
H. Virgen de las Nieves	Granada, Granada	Spain	Recruiting
H. Guadalajara	Guadalajara, Guadalajara	Spain	Recruiting
H. San Jorge	Huesca, Huesca	Spain	Recruiting
H. Santiago	Santiago de Compostela, La Coruña	Spain	Recruiting
H. San Pedro	Logroño, La Rioja	Spain	Recruiting
H. Dr. Negrín	Las Palmas de Gran Canaria, Las Palmas de Gran Canarias	Spain	Recruiting
H. 12 de octubre	Madrid, Madrid	Spain	Recruiting
H. La Paz	Madrid, Madrid	Spain	Recruiting
H. Costa del Sol	Marbella, Málaga	Spain	Recruiting
H. Navarra	Pamplona, Navarre	Spain	Recruiting
H. Río Carrión	Palencia, Palencia	Spain	Recruiting
H. Son Espases	Palma de Mallorca, Palma de Mallorca	Spain	Recruiting
H. Son Llatzer	Palma de Mallorca, Palma de Mallorca	Spain	Recruiting
H. Álvaro Cunqueiro	Vigo, Pontevedra	Spain	Recruiting
H. Univ. de Canarias	San Cristóbal de La Laguna, Santa Cruz de Tenerife	Spain	Recruiting
H. Ntra. Sra. de Candelaria	Santa Cruz de Tenerife, Santa Cruz de Tenerife	Spain	Recruiting
H. Virgen del Rocío	Seville, Sevilla	Spain	Recruiting
H. Clínico Univ. de Valencia	Valencia, Valencia	Spain	Recruiting
H. General de Valencia	Valencia, Valencia	Spain	Recruiting
H. La Fe	Valencia, Valencia	Spain	Recruiting
H. Virgen de la Concha	Zamora, Zamora	Spain	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.