Ulcerative ColitisNCT03808506
Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Fecal calprotectin
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 19 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with documented ulcerative colitis with active inflammation who are starting adalimumab therapy. All other concomittant therapies are allowed.
Who may be able to join
- Adult outpatients >=18 y of age with a confirmed diagnosis of ulcerative colitis
- Patients beginning adalimumab for active disease as clinically indicated according to the treating physician's discretion, either biologic naïve or switching biologic due to failure of prior biologic therapy
- Have had a colonoscopy or flexible sigmoidoscopy within 12 weeks of study entry
- Any other concomitant therapies are allowed (including 5'ASA, corticosteroids, azathioprine, and methotrexate).
Who cannot join
- Inability to provide informed consent
- Inability to provide a fecal calprotectin
- Contraindication to starting anti-TNF therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Baseline Burden of Disease and Anti-TNF Drug Trough Levels in Ulcerative Colitis.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. It is unknown, however, if a high burden of disease at baseline impacts drug utilization or loss. In this study, we investigate whether measures of high burden of disease (fecal calprotectin, bowel ultrasound, and colonoscopy) at baseline predicts low drug levels after standard anti-TNF induction therapy.
Read the detailed description
Biologic therapy has revolutionized the treatment of IBD. Over the past 20 years, a significant amount of research has been done to optimize biologic therapy using therapeutic drug monitoring (TDM). Evidence is accumulating suggesting that insufficient anti-TNF drug levels +/- development of anti-drug antibodies result in lower clinical efficacy, reduced mucosal healing, and loss of response. The pharmacokinetics of anti-TNF drug clearance leading to sub-therapeutic or absent drug levels can vary between and within any given patient. Clearance may be dependent on many factors such as severity of inflammation, total burden of disease, body weight, serum albumin levels, loss of drug through leaking into the stool, and immune mediated pathways with the development of anti-drug antibodies. Standard induction dosing does not take into account the severity and total burden of disease, which may have significant effects on the elimination of circulating drug.
Most data surrounding TDM pertain to maintenance of remission, during a relatively stable state of low burden of disease. Much less is known surrounding active drug levels during or immediately after induction therapy, at which point disease burden is relatively high and fluctuating. Some studies suggest improved response rates in those with higher anti-TNF drug levels during this phase of therapy. A retrospective study by Gibson et al assessed inpatients with acute severe ulcerative colitis and demonstrated reduction in colectomy rates in those who received accelerated and intensified infliximab induction therapy. Although trough levels were not provided in this study, the results suggest that standard induction dosing may be suboptimal in a setting of high burden of disease.
Colonoscopy is considered the gold standard in regards to determining burden of active disease in ulcerative colitis. However, it is invasive, requires endoscopy time, and carries risk. Non-invasive methods to determine the presence and extent of inflammation is of clinical and research interest. Fecal calprotectin (FC) is a promising tool which has now been incorporated into standard clinical care of IBD patients. It is used to monitor disease activity, assess response to therapy, and prognosticate future clinical relapse. Several meta-analyses demonstrate the correlation between FC with endoscopic disease scores in both Crohn's disease (CD) and Ulcerative Colitis (UC) with a pooled sensitivity of 85-92% and specificity of 75-88%.
Bowel Ultrasound (US) is another non-invasive method to assess inflammatory activity in UC, and is used in routine clinical practice. Bowel US correlates to inflammatory activity on colonoscopy and can be used to assess response to therapy and prognosticate future relapse. A benefit of sonography, as compared to colonoscopy and FC, is its ability to identify inflammatory changes deep to the superficial mucosa. This may provide additional information for burden of disease not recognized by other modalities. It is currently unknown if the burden of disease as found on sonography influences drug elimination and the resultant trough levels after induction therapy.
It is unknown if a high burden of disease at baseline impacts drug utilization or loss. In this study, measures of burden of disease (FC, bowel US, and colonoscopy) at baseline will be correlated to drug levels after standard anti-TNF induction therapy. It is hypothesized that a high burden of disease leads to low drug levels after standard induction dosing.
- Conditions
- Ulcerative Colitis
- Being tested
- Fecal calprotectin
- Keywords
- Ulcerative colitis, Therapeutic drug monitoring, fecal calprotectin, adalimumab, bowel ultrasound
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal calprotectinDiagnostic test
Stool test to look at baseline burden of inflammation
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis patients | Patients with documented ulcerative colitis who are initiating adalimumab therapy will have baseline bowel ultrasound and fecal calprotectin completed. Receives: Diagnostic Test: Fecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline fecal calprotectin concentration
Fecal calprotectin concentration at baseline prior to starting adalimumab therapy. Fecal Calprotectin will be used as the primary outcome measure to determine burden of inflammation
Measured: Performed within 4 weeks of starting adalimumab therapy
Secondary outcomes (3)
Post Induction fecal calprotectin concentration
Fecal calprotectin concentration will be re-assessed at week 6 after starting adalimumab therapy
Measured: Performed 6 weeks post induction therapy
Baseline Mayo Endoscopic Score
Baseline endoscopic score (as assessed by colonoscopy or flexible sigmoidoscopy) to grade the severity of mucosal inflammation. The Mayo Endoscopic score is a standard, validated, and accepted grading systems which grades inflammation from 0-3.
Measured: Performed within 12 weeks of study entry
Baseline bowel ultrasound inflammatory score
Baseline severity of inflammation based on sonographic features including bowel wall thickness, depth of mural inflammation, and degree of hypervascularity. Each component will be scored from 0-3 resulting in an ultrasound severity score of 0-9 for the segment assessed. Three segments of the colon (right colon, transverse, left colon) will be assessed and scores combined to give a total inflammatory score.
Measured: Performed within 12 weeks of starting adalimumab therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Sep 2019
- Primary completion19 Jun 2022
- Study completion19 Jul 2022
Why it stopped: no recruitment during COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Yan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brian Yan, H.B Sc, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808506
- Sponsor's protocol ID
- 113446
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017 Sep;153(3):835-857.e6. doi: 10.1053/j.gastro.2017.07.031. Epub 2017 Jul 31.
PubMed 28774547Mitrev N, Vande Casteele N, Seow CH, Andrews JM, Connor SJ, Moore GT, Barclay M, Begun J, Bryant R, Chan W, Corte C, Ghaly S, Lemberg DA, Kariyawasam V, Lewindon P, Martin J, Mountifield R, Radford-Smith G, Slobodian P, Sparrow M, Toong C, van Langenberg D, Ward MG, Leong RW; IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1037-1053. doi: 10.1111/apt.14368. Epub 2017 Oct 13.
PubMed 29027257Steenholdt C, Bendtzen K, Brynskov J, Ainsworth MA. Optimizing Treatment with TNF Inhibitors in Inflammatory Bowel Disease by Monitoring Drug Levels and Antidrug Antibodies. Inflamm Bowel Dis. 2016 Aug;22(8):1999-2015. doi: 10.1097/MIB.0000000000000772.
PubMed 27135483Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.
PubMed 16931170Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.
PubMed 24013361Ricciuto A, Dhaliwal J, Walters TD, Griffiths AM, Church PC. Clinical Outcomes With Therapeutic Drug Monitoring in Inflammatory Bowel Disease: A Systematic Review With Meta-Analysis. J Crohns Colitis. 2018 Nov 15;12(11):1302-1315. doi: 10.1093/ecco-jcc/jjy109.
PubMed 30107416Berends SE, Strik AS, Lowenberg M, D'Haens GR, Mathot RAA. Clinical Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Ulcerative Colitis. Clin Pharmacokinet. 2019 Jan;58(1):15-37. doi: 10.1007/s40262-018-0676-z.
PubMed 29752633Berends SE, Strik AS, Van Selm JC, Lowenberg M, Ponsioen CY, D'Haens GR, Mathot RA. Explaining Interpatient Variability in Adalimumab Pharmacokinetics in Patients With Crohn's Disease. Ther Drug Monit. 2018 Apr;40(2):202-211. doi: 10.1097/FTD.0000000000000494.
PubMed 29529008Brandse JF, van den Brink GR, Wildenberg ME, van der Kleij D, Rispens T, Jansen JM, Mathot RA, Ponsioen CY, Lowenberg M, D'Haens GR. Loss of Infliximab Into Feces Is Associated With Lack of Response to Therapy in Patients With Severe Ulcerative Colitis. Gastroenterology. 2015 Aug;149(2):350-5.e2. doi: 10.1053/j.gastro.2015.04.016. Epub 2015 Apr 25.
PubMed 25917786Brandse JF, Mathot RA, van der Kleij D, Rispens T, Ashruf Y, Jansen JM, Rietdijk S, Lowenberg M, Ponsioen CY, Singh S, van den Brink GR, D'Haens GR. Pharmacokinetic Features and Presence of Antidrug Antibodies Associate With Response to Infliximab Induction Therapy in Patients With Moderate to Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2016 Feb;14(2):251-8.e1-2. doi: 10.1016/j.cgh.2015.10.029. Epub 2015 Nov 9.
PubMed 26545802Brandse JF, Mould D, Smeekes O, Ashruf Y, Kuin S, Strik A, van den Brink GR, D'Haens GR. A Real-life Population Pharmacokinetic Study Reveals Factors Associated with Clearance and Immunogenicity of Infliximab in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Apr;23(4):650-660. doi: 10.1097/MIB.0000000000001043.
PubMed 28195852Papamichael K, Cheifetz AS. Therapeutic Drug Monitoring in IBD: The New Standard-of-Care for Anti-TNF Therapy. Am J Gastroenterol. 2017 May;112(5):673-676. doi: 10.1038/ajg.2017.21. Epub 2017 Feb 21. No abstract available.
PubMed 28220781Papamichael K, Vande Casteele N, Ferrante M, Gils A, Cheifetz AS. Therapeutic Drug Monitoring During Induction of Anti-Tumor Necrosis Factor Therapy in Inflammatory Bowel Disease: Defining a Therapeutic Drug Window. Inflamm Bowel Dis. 2017 Sep;23(9):1510-1515. doi: 10.1097/MIB.0000000000001231.
PubMed 28816757Papamichael K, Baert F, Tops S, Assche GV, Rutgeerts P, Vermeire S, Gils A, Ferrante M. Post-Induction Adalimumab Concentration is Associated with Short-Term Mucosal Healing in Patients with Ulcerative Colitis. J Crohns Colitis. 2017 Jan;11(1):53-59. doi: 10.1093/ecco-jcc/jjw122. Epub 2016 Jul 11.
PubMed 27402915Seow CH, Newman A, Irwin SP, Steinhart AH, Silverberg MS, Greenberg GR. Trough serum infliximab: a predictive factor of clinical outcome for infliximab treatment in acute ulcerative colitis. Gut. 2010 Jan;59(1):49-54. doi: 10.1136/gut.2009.183095.
PubMed 19651627
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Baseline Burden of Disease and Anti-TNF Drug Trough Levels in Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT03808506
- Acronym / sponsor ID
- 113446
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Therapeutic drug monitoring, fecal calprotectin, adalimumab, bowel ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no recruitment during COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 19 Jun 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 17 Jan 2019 (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.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. It is unknown, however, if a high burden of disease at baseline impacts drug utilization or loss. In this study, we investigate whether measures of high burden of disease (fecal calprotectin, bowel ultrasound, and colonoscopy) at baseline predicts low drug levels after standard anti-TNF induction therapy.
Detailed description
Biologic therapy has revolutionized the treatment of IBD. Over the past 20 years, a significant amount of research has been done to optimize biologic therapy using therapeutic drug monitoring (TDM). Evidence is accumulating suggesting that insufficient anti-TNF drug levels +/- development of anti-drug antibodies result in lower clinical efficacy, reduced mucosal healing, and loss of response. The pharmacokinetics of anti-TNF drug clearance leading to sub-therapeutic or absent drug levels can vary between and within any given patient. Clearance may be dependent on many factors such as severity of inflammation, total burden of disease, body weight, serum albumin levels, loss of drug through leaking into the stool, and immune mediated pathways with the development of anti-drug antibodies. Standard induction dosing does not take into account the severity and total burden of disease, which may have significant effects on the elimination of circulating drug.
Most data surrounding TDM pertain to maintenance of remission, during a relatively stable state of low burden of disease. Much less is known surrounding active drug levels during or immediately after induction therapy, at which point disease burden is relatively high and fluctuating. Some studies suggest improved response rates in those with higher anti-TNF drug levels during this phase of therapy. A retrospective study by Gibson et al assessed inpatients with acute severe ulcerative colitis and demonstrated reduction in colectomy rates in those who received accelerated and intensified infliximab induction therapy. Although trough levels were not provided in this study, the results suggest that standard induction dosing may be suboptimal in a setting of high burden of disease.
Colonoscopy is considered the gold standard in regards to determining burden of active disease in ulcerative colitis. However, it is invasive, requires endoscopy time, and carries risk. Non-invasive methods to determine the presence and extent of inflammation is of clinical and research interest. Fecal calprotectin (FC) is a promising tool which has now been incorporated into standard clinical care of IBD patients. It is used to monitor disease activity, assess response to therapy, and prognosticate future clinical relapse. Several meta-analyses demonstrate the correlation between FC with endoscopic disease scores in both Crohn's disease (CD) and Ulcerative Colitis (UC) with a pooled sensitivity of 85-92% and specificity of 75-88%.
Bowel Ultrasound (US) is another non-invasive method to assess inflammatory activity in UC, and is used in routine clinical practice. Bowel US correlates to inflammatory activity on colonoscopy and can be used to assess response to therapy and prognosticate future relapse. A benefit of sonography, as compared to colonoscopy and FC, is its ability to identify inflammatory changes deep to the superficial mucosa. This may provide additional information for burden of disease not recognized by other modalities. It is currently unknown if the burden of disease as found on sonography influences drug elimination and the resultant trough levels after induction therapy.
It is unknown if a high burden of disease at baseline impacts drug utilization or loss. In this study, measures of burden of disease (FC, bowel US, and colonoscopy) at baseline will be correlated to drug levels after standard anti-TNF induction therapy. It is hypothesized that a high burden of disease leads to low drug levels after standard induction dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis patients | – | Diagnostic Test: Fecal calprotectinPatients with documented ulcerative colitis who are initiating adalimumab therapy will have baseline bowel ultrasound and fecal calprotectin completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with documented ulcerative colitis with active inflammation who are starting adalimumab therapy. All other concomittant therapies are allowed.
Key inclusion criteria (4 listed)
- Adult outpatients >=18 y of age with a confirmed diagnosis of ulcerative colitis
- Patients beginning adalimumab for active disease as clinically indicated according to the treating physician's discretion, either biologic naïve or switching biologic due to failure of prior biologic therapy
- Have had a colonoscopy or flexible sigmoidoscopy within 12 weeks of study entry
- Any other concomitant therapies are allowed (including 5'ASA, corticosteroids, azathioprine, and methotrexate).
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Inability to provide a fecal calprotectin
- Contraindication to starting anti-TNF therapy
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 |
|---|---|---|
| Fecal calprotectinStool test to look at baseline burden of inflammation | Diagnostic test | Ulcerative colitis patients |
Primary outcome
Baseline fecal calprotectin concentration
Time frame: Performed within 4 weeks of starting adalimumab therapy
Fecal calprotectin concentration at baseline prior to starting adalimumab therapy. Fecal Calprotectin will be used as the primary outcome measure to determine burden of inflammation
3 secondary outcomes
Post Induction fecal calprotectin concentration
Time frame: Performed 6 weeks post induction therapy
Baseline Mayo Endoscopic Score
Time frame: Performed within 12 weeks of study entry
Baseline bowel ultrasound inflammatory score
Time frame: Performed within 12 weeks of starting adalimumab therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 28774547Vande Casteele N, Herfarth H, Katz J, Falck-Ytter Y, Singh S. American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases. Gastroenterology. 2017 Sep;153(3):835-857.e6. doi: 10.1053/j.gastro.2017.07.031. Epub 2017 Jul 31.
- Background: PubMed 29027257Mitrev N, Vande Casteele N, Seow CH, Andrews JM, Connor SJ, Moore GT, Barclay M, Begun J, Bryant R, Chan W, Corte C, Ghaly S, Lemberg DA, Kariyawasam V, Lewindon P, Martin J, Mountifield R, Radford-Smith G, Slobodian P, Sparrow M, Toong C, van Langenberg D, Ward MG, Leong RW; IBD Sydney Organisation and the Australian Inflammatory Bowel Diseases Consensus Working Group. Review article: consensus statements on therapeutic drug monitoring of anti-tumour necrosis factor therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1037-1053. doi: 10.1111/apt.14368. Epub 2017 Oct 13.
- Background: PubMed 27135483Steenholdt C, Bendtzen K, Brynskov J, Ainsworth MA. Optimizing Treatment with TNF Inhibitors in Inflammatory Bowel Disease by Monitoring Drug Levels and Antidrug Antibodies. Inflamm Bowel Dis. 2016 Aug;22(8):1999-2015. doi: 10.1097/MIB.0000000000000772.
- Background: PubMed 16931170Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.
- Background: PubMed 24013361Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.
- Background: PubMed 30107416Ricciuto A, Dhaliwal J, Walters TD, Griffiths AM, Church PC. Clinical Outcomes With Therapeutic Drug Monitoring in Inflammatory Bowel Disease: A Systematic Review With Meta-Analysis. J Crohns Colitis. 2018 Nov 15;12(11):1302-1315. doi: 10.1093/ecco-jcc/jjy109.
- Background: PubMed 29752633Berends SE, Strik AS, Lowenberg M, D'Haens GR, Mathot RAA. Clinical Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Ulcerative Colitis. Clin Pharmacokinet. 2019 Jan;58(1):15-37. doi: 10.1007/s40262-018-0676-z.
- Background: PubMed 29529008Berends SE, Strik AS, Van Selm JC, Lowenberg M, Ponsioen CY, D'Haens GR, Mathot RA. Explaining Interpatient Variability in Adalimumab Pharmacokinetics in Patients With Crohn's Disease. Ther Drug Monit. 2018 Apr;40(2):202-211. doi: 10.1097/FTD.0000000000000494.
- Background: PubMed 25917786Brandse JF, van den Brink GR, Wildenberg ME, van der Kleij D, Rispens T, Jansen JM, Mathot RA, Ponsioen CY, Lowenberg M, D'Haens GR. Loss of Infliximab Into Feces Is Associated With Lack of Response to Therapy in Patients With Severe Ulcerative Colitis. Gastroenterology. 2015 Aug;149(2):350-5.e2. doi: 10.1053/j.gastro.2015.04.016. Epub 2015 Apr 25.
- Background: PubMed 26545802Brandse JF, Mathot RA, van der Kleij D, Rispens T, Ashruf Y, Jansen JM, Rietdijk S, Lowenberg M, Ponsioen CY, Singh S, van den Brink GR, D'Haens GR. Pharmacokinetic Features and Presence of Antidrug Antibodies Associate With Response to Infliximab Induction Therapy in Patients With Moderate to Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2016 Feb;14(2):251-8.e1-2. doi: 10.1016/j.cgh.2015.10.029. Epub 2015 Nov 9.
- Background: PubMed 28195852Brandse JF, Mould D, Smeekes O, Ashruf Y, Kuin S, Strik A, van den Brink GR, D'Haens GR. A Real-life Population Pharmacokinetic Study Reveals Factors Associated with Clearance and Immunogenicity of Infliximab in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2017 Apr;23(4):650-660. doi: 10.1097/MIB.0000000000001043.
- Background: PubMed 28220781Papamichael K, Cheifetz AS. Therapeutic Drug Monitoring in IBD: The New Standard-of-Care for Anti-TNF Therapy. Am J Gastroenterol. 2017 May;112(5):673-676. doi: 10.1038/ajg.2017.21. Epub 2017 Feb 21. No abstract available.
- Individual participant dataSharing planned: No
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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.
Brian Yan, H.B Sc, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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: withdrawn, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Baseline fecal calprotectin concentration (time frame: Performed within 4 weeks of starting adalimumab therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808506, which also lists 24 linked publications.
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 9 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.