Ulcerative ColitisNCT05186623
Prediction Model for Response to Biologics and Small Molecular Agent for UC
An observational study of Ulcerative Colitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Vedolizumab, Ustekinumab, or Tofacitinib
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2022to 31 Dec 2026
- How long will I take part?
- 12 Months
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an established diagnosis of ulcerative colitis and who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled in this study. Patients who give a voluntary informed consent will be eligible.
Who may be able to join
- Patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features
- Patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment
Who cannot join
- Not Korean ethnicity by family history
- Inflammatory Bowel Disease Unclassified
- Patients who already received colectomy due to ulcerative colitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Byong Duk Ye, MD, PhD, bdye@amc.seoul.kr
About this study
Official title: Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.
Read the detailed description
In this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. In the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. Before drug administration (week 0), baseline lower GI endoscopy will be performed and colon tissues will be collected. Blood sample and fecal sample will also be collected. After induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. Combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. Similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.
- Conditions
- Ulcerative Colitis
- Being tested
- Vedolizumab, Ustekinumab, or Tofacitinib
- Keywords
- Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab, Ustekinumab, or TofacitinibDrug
Drug administration and prospective follow-up for evaluating response
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed ulcerative colitis | Patients with confirmed ulcerative colitis, who are going to receive vedolizumab therapy (n=100: development cohort n=70 and validation cohort n=30), ustekinumab therapy (n=100: development cohort n=70 and validation cohort n=30), or tofacitinib therapy (n=100: development cohort n=70 and validation cohort n=30), will be enrolled. Receives: Drug: Vedolizumab, Ustekinumab, or Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to induction therapy
A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1
Measured: Week 14 to Week 16
Secondary outcomes (7)
Remission to induction therapy
Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1
Measured: Week 14 to Week 16
Complete Mayo endoscopic subscore remission to induction therapy
Mayo endoscopic subscore of 0
Measured: Week 14 to Week 16
Ulcerative colitis endoscopic index of severity remission to induction therapy
Ulcerative colitis endoscopic index of 0 to 1
Measured: Week 14 to Week 16
Response to maintenance therapy
A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1
Measured: Week 52
Remission to maintenance therapy
Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1
Measured: Week 52
Complete Mayo endoscopic subscore remission to maintenance therapy
Mayo endoscopic subscore of 0
Measured: Week 52
Ulcerative colitis endoscopic index of severity remission to maintenance therapy
Ulcerative colitis endoscopic index of 0 to 1
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start5 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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 Asan Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byong Duk Ye, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186623
- Sponsor's protocol ID
- 2021-1718
- Status last verified
- Feb 2022
- First submitted
- 22 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
PubMed 17653185Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
PubMed 22001864Park SH, Kim YJ, Rhee KH, Kim YH, Hong SN, Kim KH, Seo SI, Cha JM, Park SY, Jeong SK, Lee JH, Park H, Kim JS, Im JP, Yoon H, Kim SH, Jang J, Kim JH, Suh SO, Kim YK, Ye BD, Yang SK; Songpa-Kangdong Inflammatory Bowel Disease [SK-IBD] Study Group. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. 2019 Oct 28;13(11):1410-1417. doi: 10.1093/ecco-jcc/jjz081.
PubMed 30989166Lee JC, Lyons PA, McKinney EF, Sowerby JM, Carr EJ, Bredin F, Rickman HM, Ratlamwala H, Hatton A, Rayner TF, Parkes M, Smith KG. Gene expression profiling of CD8+ T cells predicts prognosis in patients with Crohn disease and ulcerative colitis. J Clin Invest. 2011 Oct;121(10):4170-9. doi: 10.1172/JCI59255. Epub 2011 Sep 26.
PubMed 21946256Biasci D, Lee JC, Noor NM, Pombal DR, Hou M, Lewis N, Ahmad T, Hart A, Parkes M, McKinney EF, Lyons PA, Smith KGC. A blood-based prognostic biomarker in IBD. Gut. 2019 Aug;68(8):1386-1395. doi: 10.1136/gutjnl-2019-318343. Epub 2019 Apr 27.
PubMed 31030191Sandborn WJ. Current directions in IBD therapy: what goals are feasible with biological modifiers? Gastroenterology. 2008 Nov;135(5):1442-7. doi: 10.1053/j.gastro.2008.09.053. Epub 2008 Oct 9. No abstract available.
PubMed 18848556Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
PubMed 16339095Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
PubMed 23964932Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.
PubMed 31553833Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.
PubMed 28467869Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.
PubMed 31553834Barre A, Colombel JF, Ungaro R. Review article: predictors of response to vedolizumab and ustekinumab in inflammatory bowel disease. Aliment Pharmacol Ther. 2018 Apr;47(7):896-905. doi: 10.1111/apt.14550. Epub 2018 Feb 12.
PubMed 29430672Dulai PS, Boland BS, Singh S, Chaudrey K, Koliani-Pace JL, Kochhar G, Parikh MP, Shmidt E, Hartke J, Chilukuri P, Meserve J, Whitehead D, Hirten R, Winters AC, Katta LG, Peerani F, Narula N, Sultan K, Swaminath A, Bohm M, Lukin D, Hudesman D, Chang JT, Rivera-Nieves J, Jairath V, Zou GY, Feagan BG, Shen B, Siegel CA, Loftus EV Jr, Kane S, Sands BE, Colombel JF, Sandborn WJ, Lasch K, Cao C. Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn's Disease. Gastroenterology. 2018 Sep;155(3):687-695.e10. doi: 10.1053/j.gastro.2018.05.039. Epub 2018 May 30.
PubMed 29857091Ungar B, Kopylov U, Yavzori M, Fudim E, Picard O, Lahat A, Coscas D, Waterman M, Haj-Natour O, Orbach-Zingboim N, Mao R, Chen M, Chowers Y, Eliakim R, Ben-Horin S. Association of Vedolizumab Level, Anti-Drug Antibodies, and alpha4beta7 Occupancy With Response in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 May;16(5):697-705.e7. doi: 10.1016/j.cgh.2017.11.050. Epub 2017 Dec 7.
PubMed 29223444Zeissig S, Rosati E, Dowds CM, Aden K, Bethge J, Schulte B, Pan WH, Mishra N, Zuhayra M, Marx M, Paulsen M, Strigli A, Conrad C, Schuldt D, Sinha A, Ebsen H, Kornell SC, Nikolaus S, Arlt A, Kabelitz D, Ellrichmann M, Lutzen U, Rosenstiel PC, Franke A, Schreiber S. Vedolizumab is associated with changes in innate rather than adaptive immunity in patients with inflammatory bowel disease. Gut. 2019 Jan;68(1):25-39. doi: 10.1136/gutjnl-2018-316023. Epub 2018 May 5.
PubMed 29730603
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
- ClinicalTrials.gov ID
- NCT05186623
- Acronym / sponsor ID
- 2021-1718
- Conditions
- Ulcerative Colitis
- Keywords
- Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jan 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.
This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.
Detailed description
In this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. In the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. Before drug administration (week 0), baseline lower GI endoscopy will be performed and colon tissues will be collected. Blood sample and fecal sample will also be collected. After induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. Combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. Similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed ulcerative colitis | – | Drug: Vedolizumab, Ustekinumab, or TofacitinibPatients with confirmed ulcerative colitis, who are going to receive vedolizumab therapy (n=100: development cohort n=70 and validation cohort n=30), ustekinumab therapy (n=100: development cohort n=70 and validation cohort n=30), or tofacitinib therapy (n=100: development cohort n=70 and validation cohort n=30), will be enrolled. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an established diagnosis of ulcerative colitis and who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled in this study. Patients who give a voluntary informed consent will be eligible.
Key inclusion criteria (2 listed)
- Patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features
- Patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment
Key exclusion criteria (3 listed)
- Not Korean ethnicity by family history
- Inflammatory Bowel Disease Unclassified
- Patients who already received colectomy due to ulcerative colitis
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 |
|---|---|---|
| Vedolizumab, Ustekinumab, or TofacitinibDrug administration and prospective follow-up for evaluating response | Drug | Patients with confirmed ulcerative colitis |
Primary outcome
Response to induction therapy
Time frame: Week 14 to Week 16
A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1
7 secondary outcomes
Remission to induction therapy
Time frame: Week 14 to Week 16
Complete Mayo endoscopic subscore remission to induction therapy
Time frame: Week 14 to Week 16
Ulcerative colitis endoscopic index of severity remission to induction therapy
Time frame: Week 14 to Week 16
Response to maintenance therapy
Time frame: Week 52
Remission to maintenance therapy
Time frame: Week 52
Complete Mayo endoscopic subscore remission to maintenance therapy
Time frame: Week 52
Ulcerative colitis endoscopic index of severity remission to maintenance therapy
Time frame: Week 52
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 15 Feb 2022.
- Background: PubMed 17653185Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
- Background: PubMed 22001864Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
- Background: PubMed 30989166Park SH, Kim YJ, Rhee KH, Kim YH, Hong SN, Kim KH, Seo SI, Cha JM, Park SY, Jeong SK, Lee JH, Park H, Kim JS, Im JP, Yoon H, Kim SH, Jang J, Kim JH, Suh SO, Kim YK, Ye BD, Yang SK; Songpa-Kangdong Inflammatory Bowel Disease [SK-IBD] Study Group. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. 2019 Oct 28;13(11):1410-1417. doi: 10.1093/ecco-jcc/jjz081.
- Background: PubMed 21946256Lee JC, Lyons PA, McKinney EF, Sowerby JM, Carr EJ, Bredin F, Rickman HM, Ratlamwala H, Hatton A, Rayner TF, Parkes M, Smith KG. Gene expression profiling of CD8+ T cells predicts prognosis in patients with Crohn disease and ulcerative colitis. J Clin Invest. 2011 Oct;121(10):4170-9. doi: 10.1172/JCI59255. Epub 2011 Sep 26.
- Background: PubMed 31030191Biasci D, Lee JC, Noor NM, Pombal DR, Hou M, Lewis N, Ahmad T, Hart A, Parkes M, McKinney EF, Lyons PA, Smith KGC. A blood-based prognostic biomarker in IBD. Gut. 2019 Aug;68(8):1386-1395. doi: 10.1136/gutjnl-2019-318343. Epub 2019 Apr 27.
- Background: PubMed 18848556Sandborn WJ. Current directions in IBD therapy: what goals are feasible with biological modifiers? Gastroenterology. 2008 Nov;135(5):1442-7. doi: 10.1053/j.gastro.2008.09.053. Epub 2008 Oct 9. No abstract available.
- Background: PubMed 16339095Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
- Background: PubMed 23964932Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
- Background: PubMed 31553833Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.
- Background: PubMed 28467869Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.
- Background: PubMed 31553834Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.
- Background: PubMed 29430672Barre A, Colombel JF, Ungaro R. Review article: predictors of response to vedolizumab and ustekinumab in inflammatory bowel disease. Aliment Pharmacol Ther. 2018 Apr;47(7):896-905. doi: 10.1111/apt.14550. Epub 2018 Feb 12.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
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 Asan Medical Center at 1 site in South Korea.
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 2 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: looking for participants now, as of the sponsor's last update on 15 Feb 2022. 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 South Korea. 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?
Contact Byong Duk Ye, MD, PhD (82230103180, bdye@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to induction therapy (time frame: Week 14 to Week 16). 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 NCT05186623, which also lists 21 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 15 Feb 2022.