An observational study in Crohn Disease and Ulcerative Colitis, sponsored by Hospital de Basurto. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Hospital de Basurto · Observational
To establish the efficacy, safety, effectiveness and efficiency of monitoring the levels of anti-TNFα drugs and the levels of antibodies generated against these drugs in the treatment of patients with moderate or severe IBD (CD/CU).
An analysis will be made of the economic impact on the Health System of monitoring treatment with anti-TNFα drugs in CD/CU.
As a result of this specific objective, a standardized procedure will be established for the evaluation of the response to treatment with anti-TNFα drugs for CD/CU that includes the new trials and the new devices developed.
Exploratory objective - To conduct a cost-effectiveness (utility) analysis of a strategy for the management of stable moderate to severe CD/CU patients based on treatment monitoring.
Page 10 of 83 anti-TNFα with the introduction of screening tests for plasma levels/antibodies to IFX/ADL with respect to standard practice based on clinical signs/symptoms.
Main operational objective
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 209 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Hospital de Basurto is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) on treatment with Infliximab or Adalimumab and who have been clinically stable for 12 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort of routine practice, where the clinician will be blinded to these results. The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up.
Device: Use of the test for treatment optimization
Intervention cohort, where the clinician will have information on the test results to support decision making on treatment optimization. The randomization process will be by blocks and weighted to the ADL/IFX ratio of use of these treatments in the usual clinical practice of the participating hospitals, to guarantee a homogeneous distribution of the treatments in the groups at the beginning/end of the follow-up.
Pharmacological management of IBD
Follow-up of two cohorts made up of patients diagnosed with moderate severe CD/UC, from the Basurto University Hospital, Cruces University Hospital and San Eloy Hospital, and who are being treated with IFX/ADL, and stable in terms of disease activity
Time frame: 32 meses
Plan to share: Yes
Supporting information: Clinical study report
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Oct 2019, 32 months.
Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's 32 months is below that.
Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hospital de Basurto