GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation )

NCT02994836 | Completed Phase 4

• 1 other identifier: GIS-SUSANTI-TNF-2015
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Crohn's Disease; Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

Crohn's Disease; Inflammatory bowel disease; Anti-TNF discontinuation; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Sustained clinical remission after one year of follow-up (after discontinuing or continuing treatment with anti-TNF).

  Change at 12 months.

Secondary Outcomes (7)

• Clinical activity assessment

  Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12

• Endoscopic activity assessment

  12 Months. On the Month 0, month 12 or relapse

• Radiologic activity assessment

  12 Months. Month 0, month 12 or relapse

• Quality of life assessment

  Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12

• The Work productivity and activity assessment

  Month 0, month 1, month 2, month 4, month 6, month 8, month 10, month 12

Study Arms (2)

Anti-TNF

ACTIVE COMPARATOR

Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) or Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)

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)

Drug: Anti-TNF discontinuation: Physiological saline solution

Interventions

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

Anti-TNF discontinuation: Physiological saline solution DRUG

Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)

Anti-TNF discontinuation (Placebo)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• Age less than 18 years.
• Patients who have been treated with anti-TNF for other indication than the IBD.
• 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
• 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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Related Publications (46)

• 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.

  PMID: 15825070 BACKGROUND

• Clarke 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.

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• Louis 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.

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• Pariente 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.

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• Sorrentino 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.

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• Solberg 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.

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• Steenholdt 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.

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• Gisbert 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.

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• Bortlík 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

• 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.

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• Domenech 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.

  PMID: 16305724 BACKGROUND

• Wynands 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.

  PMID: 18376247 BACKGROUND

• Dart 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.

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• Louis 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.

  PMID: 21945953 BACKGROUND

• Lu C, Waugh A, Bailey RJ, Cherry R, Dieleman LA, Gramlich L, Matic K, Millan M, Kroeker KI, Sadowski D, Teshima CW, Todoruk D, Wong C, Wong K, Fedorak RN. Crohn's disease genotypes of patients in remission vs relapses after infliximab discontinuation. World J Gastroenterol. 2012 Sep 28;18(36):5058-64. doi: 10.3748/wjg.v18.i36.5058.

  PMID: 23049214 BACKGROUND

• Molnar T, Lakatos PL, Farkas K, Nagy F, Szepes Z, Miheller P, Horvath G, Papp M, Palatka K, Nyari T, Balint A, Lorinczy K, Wittmann T. Predictors of relapse in patients with Crohn's disease in remission after 1 year of biological therapy. Aliment Pharmacol Ther. 2013 Jan;37(2):225-33. doi: 10.1111/apt.12160. Epub 2012 Nov 26.

  PMID: 23181359 BACKGROUND

• Molander P, Farkkila M, Salminen K, Kemppainen H, Blomster T, Koskela R, Jussila A, Rautiainen H, Nissinen M, Haapamaki J, Arkkila P, Nieminen U, Kuisma J, Punkkinen J, Kolho KL, Mustonen H, Sipponen T. Outcome after discontinuation of TNFalpha-blocking therapy in patients with inflammatory bowel disease in deep remission. Inflamm Bowel Dis. 2014 Jun;20(6):1021-8. doi: 10.1097/MIB.0000000000000052.

  PMID: 24798636 BACKGROUND

• Echarri A, Ollero V, Gallego C, Porta A, Castro J. Anti-TNF withdrawal in IBD patients on deep remission. Risk factors of relapse. 20th United European Gastroenterology Week. 2012:P0287.

  BACKGROUND

• Caviglia R, Ribolsi M, Rizzi M, Emerenziani S, Annunziata M, Cicala M. Maintenance of remission with infliximab in inflammatory bowel disease: efficacy and safety long-term follow-up. World J Gastroenterol. 2007 Oct 21;13(39):5238-44. doi: 10.3748/wjg.v13.i39.5238.

  PMID: 17876895 BACKGROUND

• Ciria V, Silva P, Leo E, Trigo C, De la Cruz MD, Herrera JM, et al. Factors influencing recurrence following suspension of biological treatment. Importance of mucosal healing. J Crohns Colitis. 2014;8 (suppl.1):P487.

  BACKGROUND

• Chauvin A, Le Thuaut A, Belhassan M, Le Baleur Y, Mesli F, Bastuji-Garin S, Delchier JC, Amiot A. Infliximab as a bridge to remission maintained by antimetabolite therapy in Crohn's disease: A retrospective study. Dig Liver Dis. 2014 Aug;46(8):695-700. doi: 10.1016/j.dld.2014.04.012. Epub 2014 Jun 2.

  PMID: 24893686 BACKGROUND

• Ramos L, Hernandez A, Carrillo M, Alonso I, Hernandez N, Quintero E. Outcome of treatment with biological agents in Crohn's disease: 117 patients in 5 years from a tertiary referral center. J Crohns Colitis. 2014;8 (suppl.1):P398.

  BACKGROUND

• Luppino I, Spagnuolo R, Marasco R, Cosco C, Ruggiero G, Cosco V, et al. Withdrawal of infliximab (IFX) after achieving remission: outcome in a cohort of inflammatory bowel disease (IBD) patients. Dig Liver Dis. [Conference abstract: Abstracts of the 19th National Congress of Digestive Diseases]. 2013;45S:S100-S1.

  BACKGROUND

• Marino M, Zucchi E, Fabbro M, Lodolo I, Maieron R, Vadalà S, et al. Outcome of infliximab discontinuation in IBD patients and therapy rechallenging in relapsers: Single centre preliminary data. J Crohns Colitis. 2014;8 (suppl.1):P401.

  BACKGROUND

• Crombe V, Salleron J, Savoye G, Dupas JL, Vernier-Massouille G, Lerebours E, Cortot A, Merle V, Vasseur F, Turck D, Gower-Rousseau C, Lemann M, Colombel JF, Duhamel A. Long-term outcome of treatment with infliximab in pediatric-onset Crohn's disease: a population-based study. Inflamm Bowel Dis. 2011 Oct;17(10):2144-52. doi: 10.1002/ibd.21615. Epub 2011 Feb 1.

  PMID: 21287665 BACKGROUND

• Annunziata ML, Papparella LG, Sansoni I, Balestrieri P, Cicala M. Normalized wall thickness at MRE predicts clinical remission in Crohn's disease after infliximab discontinuation: a 5 years follow-up. J Crohns Colitis. 2014;8 (suppl.1):P402.

  BACKGROUND

• Waugh AW, Garg S, Matic K, Gramlich L, Wong C, Sadowski DC, Millan M, Bailey R, Todoruk D, Cherry R, Teshima CW, Dieleman L, Fedorak RN. Maintenance of clinical benefit in Crohn's disease patients after discontinuation of infliximab: long-term follow-up of a single centre cohort. Aliment Pharmacol Ther. 2010 Nov;32(9):1129-34. doi: 10.1111/j.1365-2036.2010.04446.x. Epub 2010 Aug 30.

  PMID: 20807218 BACKGROUND

• Nuti F, Conte F, Cavallari N, Civitelli F, Aloi M, Alessandri C, et al. Long term efficacy of infliximab in inflammatory bowel disease at a single tertiary center. Dig Liver Dis. [Congress comunication: 17th National Congress SIGENP]. 2010;42(SUPPL. 5):S326-S7.

  BACKGROUND

• Farkas K, Lakatos PL, Nagy F, Szepes Z, Miheller P, Papp M, Palatka K, Balint A, Bor R, Wittmann T, Molnar T. Predictors of relapse in patients with ulcerative colitis in remission after one-year of infliximab therapy. Scand J Gastroenterol. 2013 Dec;48(12):1394-8. doi: 10.3109/00365521.2013.845906. Epub 2013 Oct 16.

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• Armuzzi A, Marzo M, Felice C, De Vincentis F, Andrisani G, Moccio G, et al. Long-term scheduled therapy with infliximab in inflammatory bowel disease: a single-centre observational study. Gastroenterology. 2010;238 (suppl.1):S-691.

  BACKGROUND

• Muñoz C, Bravo MT, Ortiz de Zárate J, Arreba P, García I, Heras J, et al. Mucosal healing in patients with ulcerative colitis treated with infliximab. What happens after treatment is discontinued? J Crohns Colitis. 2014;8 (suppl.1):P405.

  BACKGROUND

• Dai C, Liu WX, Jiang M, Sun MJ. Mucosal healing did not predict sustained clinical remission in patients with IBD after discontinuation of one-year infliximab therapy. PLoS One. 2014 Oct 20;9(10):e110797. doi: 10.1371/journal.pone.0110797. eCollection 2014.

  PMID: 25330148 BACKGROUND

• Casanova MJ, Chaparro M, Garcia-Sanchez V, Nantes O, Leo E, Rojas-Feria M, Jauregui-Amezaga A, Garcia-Lopez S, Huguet JM, Arguelles-Arias F, Aicart M, Marin-Jimenez I, Gomez-Garcia M, Munoz F, Esteve M, Bujanda L, Cortes X, Tosca J, Pineda JR, Manosa M, Llao J, Guardiola J, Perez-Martinez I, Munoz C, Gonzalez-Lama Y, Hinojosa J, Vazquez JM, Martinez-Montiel MP, Rodriguez GE, Pajares R, Garcia-Sepulcre MF, Hernandez-Martinez A, Perez-Calle JL, Beltran B, Busquets D, Ramos L, Bermejo F, Barrio J, Barreiro-de Acosta M, Roncedo O, Calvet X, Hervias D, Gomollon F, Dominguez-Antonaya M, Alcain G, Sicilia B, Duenas C, Gutierrez A, Lorente-Poyatos R, Dominguez M, Khorrami S, Munoz C, Taxonera C, Rodriguez-Perez A, Ponferrada A, Van Domselaar M, Arias-Rivera ML, Merino O, Castro E, Marrero JM, Martin-Arranz M, Botella B, Fernandez-Salazar L, Monfort D, Opio V, Garcia-Herola A, Menacho M, Ramirez-de la Piscina P, Ceballos D, Almela P, Navarro-Llavat M, Robles-Alonso V, Vega-Lopez AB, Moraleja I, Novella MT, Castano-Milla C, Sanchez-Torres A, Benitez JM, Rodriguez C, Castro L, Garrido E, Domenech E, Garcia-Planella E, Gisbert JP. Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study. Am J Gastroenterol. 2017 Jan;112(1):120-131. doi: 10.1038/ajg.2016.569. Epub 2016 Dec 13.

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• Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.

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• Gisbert JP, Marin AC, Chaparro M. Systematic review: factors associated with relapse of inflammatory bowel disease after discontinuation of anti-TNF therapy. Aliment Pharmacol Ther. 2015 Aug;42(4):391-405. doi: 10.1111/apt.13276. Epub 2015 Jun 15.

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  BACKGROUND

• Cabriada JL, Vera I, Domenech E, Barreiro-de Acosta M, Esteve M, Gisbert JP, Panes J, Gomollon F; Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU). [Recommendations of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on the use of anti-tumor necrosis factor drugs in inflammatory bowel disease]. Gastroenterol Hepatol. 2013 Mar;36(3):127-46. doi: 10.1016/j.gastrohep.2013.01.002. Epub 2013 Feb 20. No abstract available. Spanish.

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• Brooks AJ, Sebastian S, Cross SS, Robinson K, Warren L, Wright A, Marsh AM, Tsai H, Majeed F, McAlindon ME, Preston C, Hamlin PJ, Lobo AJ. Outcome of elective withdrawal of anti-tumour necrosis factor-alpha therapy in patients with Crohn's disease in established remission. J Crohns Colitis. 2017 Dec 4;11(12):1456-1462. doi: 10.1016/j.crohns.2014.09.007.

  PMID: 25311864 BACKGROUND

• Gisbert JP, Donday MG, Riestra S, Lucendo AJ, Benitez JM, Navarro-Llavat M, Barrio J, Morales-Alvarado VJ, Rivero M, Busquets D, Leo Carnerero E, Merino O, Nantes Castillejo O, Navarro P, Van Domselaar M, Gutierrez A, Alonso-Abreu I, Mejuto R, Fernandez-Salazar L, Iborra M, Martin-Arranz MD, Pineda JR, Sampedro MJ, Serra Nilsson K, Bouhmidi A, Batista L, Munoz Villafranca C, Rodriguez-Lago I, Ceballos D, Guerra I, Manosa M, Marin Jimenez I, Torrella E, Vera Mendoza M, Casanova MJ, de Francisco R, Arias-Gonzalez L, Marin Pedrosa S, Garcia-Bosch O, Garcia-Alonso FJ, Delgado-Guillena P, Garcia MJ, Torrealba L, Nunez-Ortiz A, Vicuna Arregui M, Bosca-Watts MM, Blazquez I, Acosta D, Garre A, Baldan M, Martinez C, Barreiro-de Acosta M, Domenech E, Esteve M, Garcia-Sanchez V, Nos P, Panes J, Chaparro M; EXIT Study group of GETECCU. Withdrawal of antitumour necrosis factor in inflammatory bowel disease patients in remission: a randomised placebo-controlled clinical trial of GETECCU. Gut. 2025 Feb 6;74(3):387-396. doi: 10.1136/gutjnl-2024-333385.

  PMID: 39794921 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Javier MD Perez Gisbert, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: December 16, 2016
• Study Start: April 21, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ES (1)