Crohn's DiseasePhase 4NCT02994836
GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )
A Phase 4 study testing Anti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution and Anti-TNF:Adalimumab (Subcutaneus) in people with Crohn's Disease and Inflammatory Bowel Disease, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
This study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
- What is being tested?
- Anti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution and Anti-TNF:Adalimumab (Subcutaneus)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteSpain
- Study dates
- 21 Apr 2017to 31 Dec 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Patients diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.
- Patients older than 18 years.
- In the case of patients with Crohn's disease the indication treatment with anti-TNF it must have been for luminal involvement (no perianal).
- Are currently in clinical remission.
- The clinical remission period with the drug at non-intensified dose it must have been at least 6 months.
- The administration of ≥10 mg/kg/8 weeks or 5 mg / kg / ≤ 4 weeks, in the case of infliximab, and 40 mg / week, in the case of adalimumab, is considered an intensified dose.
Show all 9Show fewer
- At the time of inclusion, the patient should be receiving concomitant immunosuppressants (thiopurine or methotrexate) to anti-TNF treatment, and must have received these immunosuppressive drugs at stable doses for at least the last 3 months.
- In patients with Crohn's disease or ulcerative colitis disease, at baseline colonoscopy (made up to 3 months prior to the screening visit) should not be "significant" injuries.
- In the case of patients with Crohn's ileal or ileocolic disease, in magnetic resonance whole should not be "significant" injuries.(made up to 3 months prior to the screening visit)
Who cannot join
- Age less than 18 years.
- Patients who have been treated with anti-TNF for other indication than the IBD.
- Patients with Crohn's disease in which the indication for treatment with anti-TNF has been the perianal involvement (or luminal and perianal both); or showing active perianal disease at the time of inclusion.
- Patients who are not receiving concomitant treatment with immunosuppressants (thiopurine or methotrexate) at the moment (and in the previous 3 months).
- Patients undergoing bowel resection surgery; therefore, patients who began anti-TNF therapy to prevent or treat postoperative recurrence in Crohn's disease will be excluded.
- Presence of "significant" endoscopic or radiological lesions
Show all 9Show fewer
- Advanced chronic illness or any other condition that prevents the patient from coming to the clinic for monitoring or follow-up.
- Patients who are pregnant, breastfeeding or intending to become pregnant during the course of the study.
- Refusal to give consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation
This study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
Read the detailed description
A multicentre prospective randomized trial.
Hypothesis:
The discontinuation of anti-TNF treatment in inflammatory bowel disease (IBD) patients in clinical remission is associated with an increased risk of recurrence compared with maintaining such treatment.
Main objective:
To assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
Secondary objectives:
To compare treatment discontinuation vs. treatment continuation of anti-TNF agents in patients with Crohn´s disease or ulcerative colitis in terms of:
- remission (relapse-free) time,
- phenotype changes with both strategies
- mucosal healing,
- radiologic healing
- impact on quality of life and productivity
- safety
- to identify relapse predictive factors.
- To identify relapse predictive factors after anti-TNF drug discontinuation
- Determining the profile of serum cytokines in patients with both strategies, depending on drug exposure and if maintained clinical remission or relapse.
Planned number of subject to be included: 194
The participation of at 50 hospitals in Spain with an inclusion of about 5 patients per hospital is required..
Case report Form was designed on REDCap (a free, secure, web-based application designed to support data capture for research studies).
- Being tested
- Anti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution, Anti-TNF:Adalimumab (Subcutaneus)
- Keywords
- Crohn's Disease, Inflammatory bowel disease, Anti-TNF discontinuation, Ulcerative colitis
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF: Infliximab (Infusion)Biological
Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Anti-TNF discontinuation: Physiological saline solutionDrug
Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
Anti-TNF:Adalimumab (Subcutaneus)Biological
Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
Anti-TNF discontinuation: Physiological saline solutionDrug
Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF | Active comparator | Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) Receives: Biological: Anti-TNF: Infliximab (Infusion); Biological: Anti-TNF:Adalimumab (Subcutaneus) |
| Anti-TNF discontinuation (Placebo) | Placebo comparator | Physiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use) Receives: Drug: Anti-TNF discontinuation: Physiological saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Measured: Change at 12 months.
Secondary outcomes (7)
Clinical activity assessment
On Crohn´s Disease: Measure by Crohn´s Disease Activity Index (CDAI)
Measured: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
On Crohn´s Disease: Measure by Simplified endoscopic activity score for Crohn´s disease (SES-CD).
Measured: 12 Months. On the Month 0, month 12 or relapse
Radiologic activity assessment
Measure by absence of contrast enhancement, edema or presence of ulcers
Measured: 12 Months. Month 0, month 12 or relapse
Quality of life assessment
Measure by the Inflammatory Bowel Disease Questionnaire (IBDQ-9)
Measured: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
The Work productivity and activity assessment
Measure by "Spanish Work Productivity and Activity Impairment Questionnaire".This questionnaire assessments the sum of work time missed because IBD and impairment while working yields the overall work impairment (productivity loss) score. Scores are expressed as percentages of impairment/productivity loss, with higher scores indicating greater impairment.
Measured: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Clinical activity assessment
On the Ulcerative Colitis disease: Measure by Mayo Scoring System
Measured: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
On the Ulcerative Colitis disease: Measure by Mayo endoscopic score.
Measured: 12 Months. On the Month 0, month 12 or relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start21 Apr 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier MD Perez Gisbert, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994836
- Sponsor's protocol ID
- GIS-SUSANTI-TNF-2015
- Status last verified
- Feb 2023
- First submitted
- 24 Oct 2016
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lichtenstein GR, Yan S, Bala M, Blank M, Sands BE. Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. Gastroenterology. 2005 Apr;128(4):862-9. doi: 10.1053/j.gastro.2005.01.048.
PubMed 15825070Clarke K, Regueiro M. Stopping immunomodulators and biologics in inflammatory bowel disease patients in remission. Inflamm Bowel Dis. 2012 Jan;18(1):174-9. doi: 10.1002/ibd.21792. Epub 2011 Jun 14.
PubMed 21674731Louis E, Belaiche J, Reenaers C. Anti-TNF and Crohn's disease: when should we stop? Curr Drug Targets. 2010 Feb;11(2):148-51. doi: 10.2174/138945010790309957.
PubMed 20210763Pariente B, Laharie D. Review article: why, when and how to de-escalate therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2014 Aug;40(4):338-53. doi: 10.1111/apt.12838. Epub 2014 Jun 23.
PubMed 24957164Sorrentino D, Nash P, Viladomiu M, Hontecillas R, Bassaganya-Riera J. Stopping anti-TNF agents in patients with Crohn's disease in remission: is it a feasible long-term strategy? Inflamm Bowel Dis. 2014 Apr;20(4):757-66. doi: 10.1097/01.MIB.0000442680.47427.bf. No abstract available.
PubMed 24572206Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, Moum B, Lygren I; IBSEN Study Group. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1430-8. doi: 10.1016/j.cgh.2007.09.002.
PubMed 18054751Steenholdt C, Molazahi A, Ainsworth MA, Brynskov J, Ostergaard Thomsen O, Seidelin JB. Outcome after discontinuation of infliximab in patients with inflammatory bowel disease in clinical remission: an observational Danish single center study. Scand J Gastroenterol. 2012 May;47(5):518-27. doi: 10.3109/00365521.2012.660541. Epub 2012 Mar 1.
PubMed 22375898Gisbert JP, Marin AC, Chaparro M. The Risk of Relapse after Anti-TNF Discontinuation in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2016 May;111(5):632-47. doi: 10.1038/ajg.2016.54. Epub 2016 Mar 22.
PubMed 27002797Regueiro M, Kip KE, Baidoo L, Swoger JM, Schraut W. Postoperative therapy with infliximab prevents long-term Crohn's disease recurrence. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1494-502.e1. doi: 10.1016/j.cgh.2013.12.035. Epub 2014 Jan 16.
PubMed 24440221Bortlík M, Ďuricová D, Lukáš M, Malíčková K, Machková N, Hrdlička L, et al. Infliximab trough levels at treatment discontinuation are associated with increased risk of disease relapse in patients with inflammatory bowel diseases. 20th United European Gastroenterology Week. 2012:P0870.
Guidi L, Ratto C, Semeraro S, Roberto I, De Vitis I, Papa A, Marzo M, Parello A, Foglietto G, Doglietto GB, Gasbarrini GB, Fedeli G. Combined therapy with infliximab and seton drainage for perianal fistulizing Crohn's disease with anal endosonographic monitoring: a single-centre experience. Tech Coloproctol. 2008 Jun;12(2):111-7. doi: 10.1007/s10151-008-0411-0. Epub 2008 Jun 10.
PubMed 18545878Domenech E, Hinojosa J, Nos P, Garcia-Planella E, Cabre E, Bernal I, Gassull MA. Clinical evolution of luminal and perianal Crohn's disease after inducing remission with infliximab: how long should patients be treated? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1107-13. doi: 10.1111/j.1365-2036.2005.02670.x.
PubMed 16305724Wynands J, Belbouab R, Candon S, Talbotec C, Mougenot JF, Chatenoud L, Schmitz J, Cezard JP, Goulet O, Hugot JP, Ruemmele FM. 12-month follow-up after successful infliximab therapy in pediatric crohn disease. J Pediatr Gastroenterol Nutr. 2008 Mar;46(3):293-8. doi: 10.1097/MPG.0b013e31815604cd.
PubMed 18376247Dart RJ, Griffin N, Taylor K, Duncan J, Sastrillo M, Sanderson J, Irving PM. Reassessment of Crohn's disease treated with at least 12 months of anti-TNF therapy: how likely is treatment withdrawal? Frontline Gastroenterol. 2014 Jul;5(3):176-182. doi: 10.1136/flgastro-2013-100392. Epub 2013 Dec 24.
PubMed 28839767Louis E, Mary JY, Vernier-Massouille G, Grimaud JC, Bouhnik Y, Laharie D, Dupas JL, Pillant H, Picon L, Veyrac M, Flamant M, Savoye G, Jian R, Devos M, Porcher R, Paintaud G, Piver E, Colombel JF, Lemann M; Groupe D'etudes Therapeutiques Des Affections Inflammatoires Digestives. Maintenance of remission among patients with Crohn's disease on antimetabolite therapy after infliximab therapy is stopped. Gastroenterology. 2012 Jan;142(1):63-70.e5; quiz e31. doi: 10.1053/j.gastro.2011.09.034. Epub 2011 Sep 22.
PubMed 21945953
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation
- ClinicalTrials.gov ID
- NCT02994836
- Acronym / sponsor ID
- GIS-SUSANTI-TNF-2015
- Keywords
- Crohn's Disease, Inflammatory bowel disease, Anti-TNF discontinuation, Ulcerative colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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 study will be a multicentre prospective randomized trial to assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
Detailed description
A multicentre prospective randomized trial.
Hypothesis:
The discontinuation of anti-TNF treatment in inflammatory bowel disease (IBD) patients in clinical remission is associated with an increased risk of recurrence compared with maintaining such treatment.
Main objective:
To assess the percentage of patients with IBD who, after stopping anti-TNF treatment, have sustained clinical remission at one year compared to those in which the treatment is continued at stable doses
Secondary objectives:
To compare treatment discontinuation vs. treatment continuation of anti-TNF agents in patients with Crohn´s disease or ulcerative colitis in terms of:
- remission (relapse-free) time,
- phenotype changes with both strategies
- mucosal healing,
- radiologic healing
- impact on quality of life and productivity
- safety
- to identify relapse predictive factors.
- To identify relapse predictive factors after anti-TNF drug discontinuation
- Determining the profile of serum cytokines in patients with both strategies, depending on drug exposure and if maintained clinical remission or relapse.
Planned number of subject to be included: 194
The participation of at 50 hospitals in Spain with an inclusion of about 5 patients per hospital is required..
Case report Form was designed on REDCap (a free, secure, web-based application designed to support data capture for research studies).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF | Active comparator | Biological: Anti-TNF: Infliximab (Infusion), Biological: Anti-TNF:Adalimumab (Subcutaneus)Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) |
| Anti-TNF discontinuation (Placebo) | Placebo comparator | Drug: Anti-TNF discontinuation: Physiological saline solutionPhysiological saline solution (Infusion-Intravenous use) or Physiological saline solution (Injection-subcutaneous use) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients diagnosed with IBD by the usual criteria; both Crohn's and ulcerative colitis disease.
- Patients older than 18 years.
- In the case of patients with Crohn's disease the indication treatment with anti-TNF it must have been for luminal involvement (no perianal).
- Are currently in clinical remission.
- The clinical remission period with the drug at non-intensified dose it must have been at least 6 months.
Key exclusion criteria (9 listed)
- Age less than 18 years.
- Patients who have been treated with anti-TNF for other indication than the IBD.
- Patients with Crohn's disease in which the indication for treatment with anti-TNF has been the perianal involvement (or luminal and perianal both); or showing active perianal disease at the time of inclusion.
- Patients who are not receiving concomitant treatment with immunosuppressants (thiopurine or methotrexate) at the moment (and in the previous 3 months).
- Patients undergoing bowel resection surgery; therefore, patients who began anti-TNF therapy to prevent or treat postoperative recurrence in Crohn's disease will be excluded.
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 |
|---|---|---|
| Anti-TNF: Infliximab (Infusion)Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7) | Biological | Anti-TNF |
| Anti-TNF discontinuation: Physiological saline solutionPhysiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7) | Drug | Anti-TNF discontinuation (Placebo) |
| Anti-TNF:Adalimumab (Subcutaneus)Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7). | Biological | Anti-TNF |
| Anti-TNF discontinuation: Physiological saline solutionPhysiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7). | Drug | Anti-TNF discontinuation (Placebo) |
Primary outcome
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).
Time frame: Change at 12 months.
7 secondary outcomes
Clinical activity assessment
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
Time frame: 12 Months. On the Month 0, month 12 or relapse
Radiologic activity assessment
Time frame: 12 Months. Month 0, month 12 or relapse
Quality of life assessment
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
The Work productivity and activity assessment
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Clinical activity assessment
Time frame: Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12
Endoscopic activity assessment
Time frame: 12 Months. On the Month 0, month 12 or relapse
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 15825070Lichtenstein GR, Yan S, Bala M, Blank M, Sands BE. Infliximab maintenance treatment reduces hospitalizations, surgeries, and procedures in fistulizing Crohn's disease. Gastroenterology. 2005 Apr;128(4):862-9. doi: 10.1053/j.gastro.2005.01.048.
- Background: PubMed 21674731Clarke K, Regueiro M. Stopping immunomodulators and biologics in inflammatory bowel disease patients in remission. Inflamm Bowel Dis. 2012 Jan;18(1):174-9. doi: 10.1002/ibd.21792. Epub 2011 Jun 14.
- Background: PubMed 20210763Louis E, Belaiche J, Reenaers C. Anti-TNF and Crohn's disease: when should we stop? Curr Drug Targets. 2010 Feb;11(2):148-51. doi: 10.2174/138945010790309957.
- Background: PubMed 24957164Pariente B, Laharie D. Review article: why, when and how to de-escalate therapy in inflammatory bowel diseases. Aliment Pharmacol Ther. 2014 Aug;40(4):338-53. doi: 10.1111/apt.12838. Epub 2014 Jun 23.
- Background: PubMed 24572206Sorrentino D, Nash P, Viladomiu M, Hontecillas R, Bassaganya-Riera J. Stopping anti-TNF agents in patients with Crohn's disease in remission: is it a feasible long-term strategy? Inflamm Bowel Dis. 2014 Apr;20(4):757-66. doi: 10.1097/01.MIB.0000442680.47427.bf. No abstract available.
- Background: PubMed 18054751Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, Moum B, Lygren I; IBSEN Study Group. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1430-8. doi: 10.1016/j.cgh.2007.09.002.
- Background: PubMed 22375898Steenholdt C, Molazahi A, Ainsworth MA, Brynskov J, Ostergaard Thomsen O, Seidelin JB. Outcome after discontinuation of infliximab in patients with inflammatory bowel disease in clinical remission: an observational Danish single center study. Scand J Gastroenterol. 2012 May;47(5):518-27. doi: 10.3109/00365521.2012.660541. Epub 2012 Mar 1.
- Background: PubMed 27002797Gisbert JP, Marin AC, Chaparro M. The Risk of Relapse after Anti-TNF Discontinuation in Inflammatory Bowel Disease: Systematic Review and Meta-Analysis. Am J Gastroenterol. 2016 May;111(5):632-47. doi: 10.1038/ajg.2016.54. Epub 2016 Mar 22.
- Background: PubMed 24440221Regueiro M, Kip KE, Baidoo L, Swoger JM, Schraut W. Postoperative therapy with infliximab prevents long-term Crohn's disease recurrence. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1494-502.e1. doi: 10.1016/j.cgh.2013.12.035. Epub 2014 Jan 16.
- BackgroundBortlík M, Ďuricová D, Lukáš M, Malíčková K, Machková N, Hrdlička L, et al. Infliximab trough levels at treatment discontinuation are associated with increased risk of disease relapse in patients with inflammatory bowel diseases. 20th United European Gastroenterology Week. 2012:P0870.
- Background: PubMed 18545878Guidi L, Ratto C, Semeraro S, Roberto I, De Vitis I, Papa A, Marzo M, Parello A, Foglietto G, Doglietto GB, Gasbarrini GB, Fedeli G. Combined therapy with infliximab and seton drainage for perianal fistulizing Crohn's disease with anal endosonographic monitoring: a single-centre experience. Tech Coloproctol. 2008 Jun;12(2):111-7. doi: 10.1007/s10151-008-0411-0. Epub 2008 Jun 10.
- Background: PubMed 16305724Domenech E, Hinojosa J, Nos P, Garcia-Planella E, Cabre E, Bernal I, Gassull MA. Clinical evolution of luminal and perianal Crohn's disease after inducing remission with infliximab: how long should patients be treated? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1107-13. doi: 10.1111/j.1365-2036.2005.02670.x.
Related trials for Crohn's Disease
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. This study is not recruiting at the moment.
Javier MD Perez Gisbert, PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-TNF: Infliximab (Infusion), Anti-TNF discontinuation: Physiological saline solution and Anti-TNF:Adalimumab (Subcutaneus) in people with Crohn's Disease and Inflammatory Bowel Disease, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 9 inclusion and 9 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: finished, as of the sponsor's last update on 1 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF). (time frame: Change at 12 months.). 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 NCT02994836, which also lists 46 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 1 Mar 2023.