An observational study in Ulcerative Colitis, sponsored by Hospital San Carlos, Madrid. Completed at 12 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Hospital San Carlos, Madrid · Observational
Proactive therapeutic drug monitoring of Anti-TNFs with drug titration to a therapeutic window is associated with favorable long-term therapeutic outcomes in IBD and may be superior to reactive therapeutic drug monitoring. Moreover, many exposure-response relationship studies have shown that higher serum anti-TNF drug concentrations are associated with better clinical outcomes in IBD, suggesting that it is maybe time to go from a 'treat-to-target' to a 'treat-to trough' therapeutic approach. In this scenario, there are very limited data regarding therapeutic drug monitoring with golimumab in UC and even no data regarding a therapeutic window to target for important objectives outcomes like mucosal healing and histological remission.
Tumor necrosis factor (TNF)-α antagonists have changed the goals of ulcerative colitis (UC) treatment, with the focus now on preventing disease progression rather than just controlling symptoms. Anti-TNF agents have shown ability to achieve clinical remission and mucosal healing in UC. However, histological remission represents a target distinct from endoscopic healing in UC, and seems a better predictor of clinical outcomes. Moreover, histological remission and not mucosal healing has been associated with a reduced risk of colorectal cancer in UC. Infliximab was reported to induce histological remission in a significant proportion of UC patients. More recently, adalimumab was able to achieve histological remission in nearly one-third of anti-TNF naïve patients with moderately to severely active UC.
Reactive therapeutic drug monitoring of anti-TNF agents may help to identify mechanisms for loss of response and to guide selection of optimal intervention in individual patients and has been shown to be cost-effective compared with empiric dose escalation. Proactive therapeutic drug monitoring showed that anti-TNF trough levels are correlated with clinical response, clinical remission and mucosal healing in patients with inflammatory bowel disease (IBD). Conversely, inadequate serum drug concentrations and antidrug antibodies are associated with poor clinical outcomes. Recently, a study demonstrated that infliximab trough concentrations during maintenance therapy are associated with endoscopic and histologic healing in patients with UC.
Golimumab, a subcutaneously administered fully human antibody to TNF, induces clinical response and remission in patients with moderately to severely active UC. In patients who responded to induction therapy, golimumab doses administered every 4 weeks as a maintenance regimen was effective in maintaining clinical response through 1 year. Available data on golimumab drug monitoring and exposure-response relationship in UC patients are from the PURSUIT trials. A positive association between golimumab levels and efficacy outcomes, including mucosal healing, was confirmed during both induction and maintenance portions of the PURSUIT studies.
Real life data regarding golimumab concentrations and clinical outcomes are lacking, with only a small observational study published. Besides, there are no data regarding the ability of golimumab to achieve histological remission in UC patients.
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's enrollment of 52 is below the median of 158 across 404 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Hospital San Carlos, Madrid is the lead sponsor of 72 studies on the registry; 16 are open to participants now.
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Eligible patients will include patients of at least 18 years old with moderate to severe UC treated with maintenance therapy with golimumab according to usual clinical practice and have received the induction regimen with the drug according to the EU label, followed by maintenance treatment for at least 6 months from the first dose of drug.
The study population will comprise all consecutive patients in which a programmed colonoscopy is indicated according to clinical practice for one of the following reasons:
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:
Golimumab trough levels taken immediately before the administration of the next subcutaneous dose of golimumab
Antibodies to golimumab taken immediately before the administration of the next subcutaneous dose of golimumab
Histology of colonic biopsies using the Geboes Index
Colonoscopy to evaluate the endoscopic activity by a Mayo endoscopic subscore
Correlation between Golimumab trough levels and Endoscopic remission
defined as a Mayo endoscopic subscore of 0
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Correlation between Golimumab trough levels and Endoscopic healing
defined as a Mayo endoscopic subscore of 0 or 1
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Correlation between Golimumab trough levels and Histological remission
defined as a Geboes index ≤3.0
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Correlation between Golimumab trough levels and Clinical remission
defined as a total Mayo score ≤2 with no individual subscore exceeding 1 point
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Correlation between Golimumab trough levels and Clinical response
defined as a decrease from baseline in the total Mayo score of at least 3-points
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Receiver operating characteristic curve analysis
Thresholds of golimumab levels for outcomes 1 to 5 will be determined using the receiver operating characteristic curve analysis.
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
C-reactive protein and fecal calprotectin.
Correlation between Golimumab trough levels with C-reactive protein and fecal calprotectin.
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
Histological remission
Proportion of patients with Histological remission defined as a Geboes index ≤3.0
Time frame: Cross-Sectional: 15 days before or after the extraction of levels
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Hospital San Carlos, Madrid