Golimumab Trough Levels in Patients With Ulcerative Colitis
NCT ID: NCT03773445
Last Updated: 2022-04-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
52 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-03-01
Study Completion Date
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimization of Golimumab Treatment in Ulcerative Colitis
NCT03669029
Colitis, Ulcerative
UNKNOWN
PHASE4
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
NCT03124121
Ulcerative Colitis
COMPLETED
PHASE4
Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis
NCT02277470
Ulcerative Colitis
UNKNOWN
Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
NCT03182166
Ulcerative Colitis
COMPLETED
PHASE2
Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET
NCT02425865
ULCERATIVE COLITIS
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ulcerative Colitis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Golimumab trough levels
Golimumab trough levels taken immediately before the administration of the next subcutaneous dose of golimumab
Intervention Type
DIAGNOSTIC_TEST
Antibodies to golimumab
Antibodies to golimumab taken immediately before the administration of the next subcutaneous dose of golimumab
Intervention Type
DIAGNOSTIC_TEST
Histology
Histology of colonic biopsies using the Geboes Index
Intervention Type
DIAGNOSTIC_TEST
Colonoscopy
Colonoscopy to evaluate the endoscopic activity by a Mayo endoscopic subscore
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age greater than or equal to 18 years.
* Patients with a diagnosis of ulcerative colitis at least 12 months prior to the start of the study.
* Patients previously treated with golimumab for ulcerative colitis prescribed according to the usual clinical practice of each center and who have received at least 5 maintenance doses according to the guidelines accepted in the technical file.
* Sign of informed consent.
* Patients with a diagnosis of ulcerative colitis at least 12 months prior to the start of the study.
* Patients previously treated with golimumab for ulcerative colitis prescribed according to the usual clinical practice of each center and who have received at least 5 maintenance doses according to the guidelines accepted in the technical file.
* Sign of informed consent.
Exclusion Criteria
* Patients with Crohn's disease or colitis pending classification
* Alterations in the coagulation that contraindicate the taking of biopsies
* Patients with moderate-severe heart failure (grades III / IV NYHA)
* Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections
* Psychiatric illness that discourages participation in the study
* Patients with a history of hypersensitivity to golimumab, to other murine proteins or to any of the excipients included in the golimumab data sheet
* Withdrawal of the informed consent by the patient
* Any other condition that in the opinion of the investigator discourages the participation of the subject in the study.
* Alterations in the coagulation that contraindicate the taking of biopsies
* Patients with moderate-severe heart failure (grades III / IV NYHA)
* Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections
* Psychiatric illness that discourages participation in the study
* Patients with a history of hypersensitivity to golimumab, to other murine proteins or to any of the excipients included in the golimumab data sheet
* Withdrawal of the informed consent by the patient
* Any other condition that in the opinion of the investigator discourages the participation of the subject in the study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario La Fe
OTHER
Sponsor Role
collaborator
Hospital Universitario 12 de Octubre
OTHER
Sponsor Role
collaborator
Hospital Universitario Ramon y Cajal
OTHER
Sponsor Role
collaborator
Gregorio Marañón Hospital
OTHER
Sponsor Role
collaborator
Complejo Hospitalario de Navarra
OTHER
Sponsor Role
collaborator
Hospital Universitario Fundación Alcorcón
OTHER
Sponsor Role
collaborator
Hospital Infanta Sofia
OTHER
Sponsor Role
collaborator
Hospital Clínico Universitario de Valencia
OTHER
Sponsor Role
collaborator
Puerta de Hierro University Hospital
OTHER
Sponsor Role
collaborator
Hospital Universitario La Paz
OTHER
Sponsor Role
collaborator
Hospital Universitario de Fuenlabrada
OTHER
Sponsor Role
collaborator
Merck Sharp & Dohme LLC
INDUSTRY
Sponsor Role
collaborator
Hospital San Carlos, Madrid
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carlos Taxonera
Dr.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos Taxonera, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital San Carlos, Madrid
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Site Status
Hospital Universitario Fuenlabrada
Fuenlabrada, Madrid, Spain
Site Status
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Site Status
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Site Status
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Site Status
Hospital Gregorio Marañón
Madrid, , Spain
Site Status
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Clinico San Carlos
Madrid, , Spain
Site Status
Hospital 12 de Octubre
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Site Status
Hospital Universitario La Fe
Valencia, , Spain
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Spain
References
Explore related publications, articles, or registry entries linked to this study.
Rutgeerts 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.
Reference Type
RESULT
Sandborn WJ, van Assche G, Reinisch W, Colombel JF, D'Haens G, Wolf DC, Kron M, Tighe MB, Lazar A, Thakkar RB. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012 Feb;142(2):257-65.e1-3. doi: 10.1053/j.gastro.2011.10.032. Epub 2011 Nov 4.
Reference Type
RESULT
Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.
Reference Type
RESULT
Rosenberg L, Nanda KS, Zenlea T, Gifford A, Lawlor GO, Falchuk KR, Wolf JL, Cheifetz AS, Goldsmith JD, Moss AC. Histologic markers of inflammation in patients with ulcerative colitis in clinical remission. Clin Gastroenterol Hepatol. 2013 Aug;11(8):991-6. doi: 10.1016/j.cgh.2013.02.030. Epub 2013 Apr 13.
Reference Type
RESULT
Zenlea T, Yee EU, Rosenberg L, Boyle M, Nanda KS, Wolf JL, Falchuk KR, Cheifetz AS, Goldsmith JD, Moss AC. Histology Grade Is Independently Associated With Relapse Risk in Patients With Ulcerative Colitis in Clinical Remission: A Prospective Study. Am J Gastroenterol. 2016 May;111(5):685-90. doi: 10.1038/ajg.2016.50. Epub 2016 Mar 15.
Reference Type
RESULT
Bryant RV, Burger DC, Delo J, Walsh AJ, Thomas S, von Herbay A, Buchel OC, White L, Brain O, Keshav S, Warren BF, Travis SP. Beyond endoscopic mucosal healing in UC: histological remission better predicts corticosteroid use and hospitalisation over 6 years of follow-up. Gut. 2016 Mar;65(3):408-14. doi: 10.1136/gutjnl-2015-309598. Epub 2015 May 18.
Reference Type
RESULT
Rutter M, Saunders B, Wilkinson K, Rumbles S, Schofield G, Kamm M, Williams C, Price A, Talbot I, Forbes A. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004 Feb;126(2):451-9. doi: 10.1053/j.gastro.2003.11.010.
Reference Type
RESULT
Gupta RB, Harpaz N, Itzkowitz S, Hossain S, Matula S, Kornbluth A, Bodian C, Ullman T. Histologic inflammation is a risk factor for progression to colorectal neoplasia in ulcerative colitis: a cohort study. Gastroenterology. 2007 Oct;133(4):1099-105; quiz 1340-1. doi: 10.1053/j.gastro.2007.08.001. Epub 2007 Aug 2.
Reference Type
RESULT
Korelitz BI, Sultan K, Kothari M, Arapos L, Schneider J, Panagopoulos G. Histological healing favors lower risk of colon carcinoma in extensive ulcerative colitis. World J Gastroenterol. 2014 May 7;20(17):4980-6. doi: 10.3748/wjg.v20.i17.4980.
Reference Type
RESULT
Wiernicka A, Szymanska S, Cielecka-Kuszyk J, Dadalski M, Kierkus J. Histological healing after infliximab induction therapy in children with ulcerative colitis. World J Gastroenterol. 2015 Oct 7;21(37):10654-61. doi: 10.3748/wjg.v21.i37.10654.
Reference Type
RESULT
Magro F, Lopes SI, Lopes J, Portela F, Cotter J, Lopes S, Moreira MJ, Lago P, Peixe P, Albuquerque A, Rodrigues S, Silva MR, Monteiro P, Lopes C, Monteiro L, Macedo G, Veloso L, Camila C, Afonso J, Geboes K, Carneiro F; Portuguese IBD group [GEDII]. Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab. J Crohns Colitis. 2016 Dec;10(12):1407-1416. doi: 10.1093/ecco-jcc/jjw112. Epub 2016 May 25.
Reference Type
RESULT
Fernandez-Blanco JI, Fernandez-Diaz G, Cara C, Vera MI, Olivares D, Taxonera C. Adalimumab for Induction of Histological Remission in Moderately to Severely Active Ulcerative Colitis. Dig Dis Sci. 2018 Mar;63(3):731-737. doi: 10.1007/s10620-018-4935-5. Epub 2018 Jan 25.
Reference Type
RESULT
Steenholdt C, Brynskov J, Thomsen OO, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22.
Reference Type
RESULT
Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.
Reference Type
RESULT
Maser 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.
Reference Type
RESULT
Seow 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.
Reference Type
RESULT
Paul 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.
Reference Type
RESULT
Vande Casteele N, Ferrante M, Van Assche G, Ballet V, Compernolle G, Van Steen K, Simoens S, Rutgeerts P, Gils A, Vermeire S. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015 Jun;148(7):1320-9.e3. doi: 10.1053/j.gastro.2015.02.031. Epub 2015 Feb 24.
Reference Type
RESULT
Cornillie F, Hanauer SB, Diamond RH, Wang J, Tang KL, Xu Z, Rutgeerts P, Vermeire S. Postinduction serum infliximab trough level and decrease of C-reactive protein level are associated with durable sustained response to infliximab: a retrospective analysis of the ACCENT I trial. Gut. 2014 Nov;63(11):1721-7. doi: 10.1136/gutjnl-2012-304094. Epub 2014 Jan 28.
Reference Type
RESULT
Adedokun OJ, Sandborn WJ, Feagan BG, Rutgeerts P, Xu Z, Marano CW, Johanns J, Zhou H, Davis HM, Cornillie F, Reinisch W. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology. 2014 Dec;147(6):1296-1307.e5. doi: 10.1053/j.gastro.2014.08.035. Epub 2014 Aug 28.
Reference Type
RESULT
Vande Casteele N, Khanna R, Levesque BG, Stitt L, Zou GY, Singh S, Lockton S, Hauenstein S, Ohrmund L, Greenberg GR, Rutgeerts PJ, Gils A, Sandborn WJ, Vermeire S, Feagan BG. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn's disease. Gut. 2015 Oct;64(10):1539-45. doi: 10.1136/gutjnl-2014-307883. Epub 2014 Oct 21.
Reference Type
RESULT
Papamichael K, Rakowsky S, Rivera C, Cheifetz AS, Osterman MT. Infliximab trough concentrations during maintenance therapy are associated with endoscopic and histologic healing in ulcerative colitis. Aliment Pharmacol Ther. 2018 Feb;47(4):478-484. doi: 10.1111/apt.14458. Epub 2017 Dec 6.
Reference Type
RESULT
Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.
Reference Type
RESULT
Adedokun OJ, Xu Z, Marano CW, Strauss R, Zhang H, Johanns J, Zhou H, Davis HM, Reinisch W, Feagan BG, Rutgeerts P, Sandborn WJ. Pharmacokinetics and Exposure-response Relationship of Golimumab in Patients with Moderately-to-Severely Active Ulcerative Colitis: Results from Phase 2/3 PURSUIT Induction and Maintenance Studies. J Crohns Colitis. 2017 Jan;11(1):35-46. doi: 10.1093/ecco-jcc/jjw133. Epub 2016 Jul 20.
Reference Type
RESULT
Detrez I, Dreesen E, Van Stappen T, de Vries A, Brouwers E, Van Assche G, Vermeire S, Ferrante M, Gils A. Variability in Golimumab Exposure: A 'Real-Life' Observational Study in Active Ulcerative Colitis. J Crohns Colitis. 2016 May;10(5):575-81. doi: 10.1093/ecco-jcc/jjv241. Epub 2016 Jan 6.
Reference Type
RESULT
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTS-GOL-2018-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea
NCT02229344
COMPLETED
Histopathologic and Lymphocyte Subpopulations Evaluation of the Upper Gastrointestinal Tract of Crohn's Disease
NCT05874349
COMPLETED
Early Serum Infliximab Levels in Severe Ulcerative Colitis.
NCT01971814
COMPLETED
PHASE1
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
NCT03018925
COMPLETED
Identification of Predictive Biomarkers for Response to Biologic Therapies and Tofacitinib in Inflammatory Bowel Disease
NCT03885713
COMPLETED
PHASE4
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
NCT03596645
ACTIVE_NOT_RECRUITING
PHASE3
The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
NCT03778918
UNKNOWN
The Belgian SMART Study Evaluating the Use of Golimumab for Ulcerative Colitis
NCT02914717
COMPLETED
Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis
NCT05653791
UNKNOWN
Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab
NCT03394586
UNKNOWN
Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
NCT05735665
UNKNOWN
NA
Immunological Characteristics of Preclinical IBD
NCT05698745
RECRUITING
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
NCT02508012
COMPLETED
NA
PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease
NCT06758024
RECRUITING
NA
Remote Monitoring of IBD
NCT05886322
UNKNOWN
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03662542
COMPLETED
PHASE2
Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
NCT02073526
COMPLETED
A Prospective Study on the Incidence and Risk Factors Related to Infection in Patients With Inflammatory Bowel Disease
NCT02904590
COMPLETED
Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease
NCT05733845
RECRUITING
NA
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
NCT01900574
COMPLETED
PHASE1
Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis
NCT02438410
COMPLETED
Characterization of the Intestinal Microbiota in Patients With Inflammatory Bowel Disease and/or Spondyloarthritis and Study of the Impact of an Anti-TNF Alpha Therapy
NCT03359642
COMPLETED
NA
Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
NCT01408810
COMPLETED
PHASE4
Improved and Simplified Staining Technique for Dysplasia Detection in Colitis
NCT06223347
RECRUITING