Crohn DiseaseGRACENCT05636709
National GMA Post-market Clinical Follow-up Study (GRACE)
An observational study of Crohn Disease and Ulcerative Colitis, run by Adacyte Therapeutics SL at 30 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- Adacolumn
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 30 sitesSpain
- Study dates
- 11 Jan 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- ≥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.
- Patients who understand and voluntarily sign informed consent.
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Spain30 sites
H. Albacete
Albacete, Albacete, 02006
H. General de Alicante
Alicante, Alicante, 03010
H. Germans Trias i Pujol
Badalona, Barcelona, 08916
H. Vall d´hebron
Barcelona, Barcelona, 08035
H. Puerta del Mar
Cadiz, Cádiz, 11009
H. General de Castellón
Castellon, Castellón, 12004
H. Reina Sofía
Córdoba, Córdoba, 14004
H. Galdakao
Galdakao, Bizkaia, 48960
H. Virgen de las Nieves
Granada, Granada, 18014
H. Guadalajara
Guadalajara, Guadalajara, 19002
H. San Jorge
Huesca, Huesca, 22004
H. Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas de Gran Canarias, 35010
H. San Pedro
Logroño, La Rioja, 98
H. 12 de octubre
Madrid, Madrid, 28041
H. La Paz
Madrid, Madrid, 28046
H. Costa del Sol
Marbella, Málaga, 29603
H. Río Carrión
Palencia, Palencia, 34005
H. Son Espases
Palma de Mallorca, Palma de Mallorca, 07120
H. Son Llatzer
Palma de Mallorca, Palma de Mallorca, 07198
H. Navarra
Pamplona, Navarre, 31008
H. Univ. de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
H. Donostia
San Sebastián, Gipuzkoa, 20014
H. Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
H. Santiago
Santiago de Compostela, La Coruña, 15706
H. Virgen del Rocío
Seville, Sevilla, 41013
H. Clínico Univ. de Valencia
Valencia, Valencia, 46010
H. General de Valencia
Valencia, Valencia, 46014
H. La Fe
Valencia, Valencia, 46026
H. Álvaro Cunqueiro
Vigo, Pontevedra, 36312
H. Virgen de la Concha
Zamora, Zamora, 49022
About this study
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
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.
Read more
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.
Read the detailed description
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.
Once the patient has been adequately informed, his/her eligibility has been confirmed and he/she has signed the informed consent (IC), the investigator will start data collection in an appropriate and precise manner. Therefore, no diagnostic or therapeutic intervention outside of routine clinical practice will be applied. To ensure the noninterventional nature of the study, the data will be collected provided they are available in the patient's medical record or can be collected during patient visits to his/her physician as part of actual clinical care (as in the case of questionnaires used as source documents).
Adacolumn® is a medical device intended for modifying the biological or chemical composition of the blood (class IIb), according to Regulation (UE) 2017/745 on Medical Devices, manufactured by Japan Immnunoresearch Laboratories, JIMRO (Takasaki, Japan). It consists of a 335 ml column formed by cellulose acetate beads of 2 mm in diameter bathed in saline, where granulocytes (65%), monocytes (55%), and only 2% of lymphocytes are selectively adsorbed.
Adacolumn® is indicated for induction of remission in patients with IBD (active UC and CD), for suppression of subjective and objective symptoms in patients with rheumatoid arthritis in the inflammatory stage whose symptoms might be resistant to standard drug therapy, for treatment of patients with ocular Behcet disease and for treatment of patients with systemic lupus erythematosus.
In this study, the intended use of Adacolumn® is for application of GMA in patients diagnosed with IBD, both UC and CD
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- Adacolumn
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdacolumnDevice
Non interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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
Measured: 12 months
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.
Measured: 1 month
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.
Measured: 6 and 12-month
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.
Measured: 12 months
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.
Measured: 6 and 12-month
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.
Measured: 12 months
Rate of patients requiring steroids and mean dose during follow-up
- Rate of patients requiring steroids
- Mean dose of steroids
Steroids in mg
Measured: 12 months
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.
Measured: 12 months
Rate of treatment-related adverse events (AEs) and seriousness
Frequency of treatment-related AEs and seriousness
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start11 Jan 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adacyte Therapeutics SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Luis Cabriada, Study chair, H. GaldakaoIago Rodríguez, Study chair, H. GaldakaoDaniel Ginard, Study chair, H. Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636709
- Sponsor's protocol ID
- GRACE
- Acronym
- GRACE
- Status last verified
- Nov 2026
- First submitted
- 24 Aug 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- GRACE / GRACE
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Adacyte Therapeutics SLIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Once the patient has been adequately informed, his/her eligibility has been confirmed and he/she has signed the informed consent (IC), the investigator will start data collection in an appropriate and precise manner. Therefore, no diagnostic or therapeutic intervention outside of routine clinical practice will be applied. To ensure the noninterventional nature of the study, the data will be collected provided they are available in the patient's medical record or can be collected during patient visits to his/her physician as part of actual clinical care (as in the case of questionnaires used as source documents).
Adacolumn® is a medical device intended for modifying the biological or chemical composition of the blood (class IIb), according to Regulation (UE) 2017/745 on Medical Devices, manufactured by Japan Immnunoresearch Laboratories, JIMRO (Takasaki, Japan). It consists of a 335 ml column formed by cellulose acetate beads of 2 mm in diameter bathed in saline, where granulocytes (65%), monocytes (55%), and only 2% of lymphocytes are selectively adsorbed.
Adacolumn® is indicated for induction of remission in patients with IBD (active UC and CD), for suppression of subjective and objective symptoms in patients with rheumatoid arthritis in the inflammatory stage whose symptoms might be resistant to standard drug therapy, for treatment of patients with ocular Behcet disease and for treatment of patients with systemic lupus erythematosus.
In this study, the intended use of Adacolumn® is for application of GMA in patients diagnosed with IBD, both UC and CD
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥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.
- Patients who understand and voluntarily sign informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdacolumnNon interventional study | Device | – |
Primary outcome
Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy
Time frame: 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.
11 secondary outcomes
Define the regimens used for GMA in actual clinical practice.
Time frame: 12 months
Early clinical remission rate
Time frame: 1 month
6- and 12-month remission rates completion of GMA therapy
Time frame: 6 and 12-month
Sustained clinical remission rate
Time frame: 12 months
6- and 12-month clinical response rates
Time frame: 6 and 12-month
Rate of patients receiving GMA as maintenance and its efficacy
Time frame: 12 months
Rate of patients requiring steroids and mean dose during follow-up
Time frame: 12 months
Changes in faecal calprotectin and C-reactive protein (CRP) biomarkers during treatment
Time frame: 12 months
Rate of treatment-related adverse events (AEs) and seriousness
Time frame: 6 months
Change in patients' quality of life
Time frame: 6 months
Number of patients requiring surgery
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Cabriada study chair
H. Galdakao
Iago Rodríguez study chair
H. Galdakao
Daniel Ginard study chair
H. Son Espases
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by Adacyte Therapeutics SL at 30 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.