ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This PMCF study will collect real-world data on Adacolumn® granulocytapheresis for UC and Crohn’s, focusing on steroid-free remission and use patterns — information patients and clinicians may use when considering GMA as a treatment or bridge strategy.
It documents how the device is used across multiple centres and captures outcomes over 12 months.
Who Should Pay Attention
Adult patients with UC or Crohn’s disease considering or receiving GMA; gastroenterologists and IBD clinicians; researchers studying post-market device effectiveness.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment350 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This is a national, multicentre, non-interventional post-market clinical follow-up (PMCF) study (GRACE) of Adacolumn® granulocytapheresis (GMA) in adults with ulcerative colitis or Crohn’s disease conducted in Spain. The study plans to enroll ~350 patients across ~30 centres and follows patients for up to 12 months after completion of GMA therapy.
The primary outcome recorded is the proportion of patients achieving steroid-free clinical remission at 6 months after completion of GMA therapy.
The protocol follows routine clinical visits and does not introduce interventions beyond standard care; treatment regimens described include typical induction (one session/week for 5 weeks) and maintenance schedules and note that more sessions are sometimes used in refractory cases.
This registry-style study is intended to evaluate real-world effectiveness and patterns of use of the Adacolumn device after market approval. Because it is observational and non-interventional, it will capture outcomes and treatment changes as they occur in routine practice rather than from a randomized assignment.
Keep In Mind
Observational, non-interventional design means no randomized comparison; findings will reflect routine practice and possible selection biases. This is a trial record describing planned follow-up and outcomes, not results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorAdacyte Therapeutics SL
Trial IDNCT05636709
Study typeObservational
Enrollment350 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedNov 4, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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