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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.
This clinical trial in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.
The primary endpoint is clinical relapse at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perianal Crohn's patient | Experimental | Stopping biological therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stopping biological therapy | Other | Stopping biological therapy The primary endpoint is clinical relapse at 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perianal Crohn's disease relapse within 12 months after stopping | Relapse rate of patient will be calculated | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy | Relapse rate of patient will be calculated | 12 months |
| Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wing Yan Mak, MRCP | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30165543 | Background | Mak WY, Mak OS, Lee CK, Tang W, Leung WK, Wong MTL, Sze ASF, Li M, Leung CM, Lo FH, Lam BCY, Chan KH, Shan EHS, Tsang SWC, Hui AJ, Chow WH, Chan FKL, Sung JJY, Ng SC. Significant Medical and Surgical Morbidity in Perianal Crohn's Disease: Results from a Territory-Wide Study. J Crohns Colitis. 2018 Nov 28;12(12):1392-1398. doi: 10.1093/ecco-jcc/jjy120. | |
| 16530505 |
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Relapse rate of patient will be calculated
| 12 months |
| Factors associated with relapse of perianal Crohn's disease after stopping biological therapy | Factors associated factors will be measured by questionnaire and clinical assessment | 12 months |
| Factors associated with relapse of luminal Crohn's disease after stopping biological therapy | Factors associated factors will be measured by questionnaire and clinical assessment | 12 months |
| Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. doi: 10.1053/j.gastro.2005.12.019. |
| 14985485 | Background | Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815. |
| 17241859 | Background | Colombel JF, Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Panaccione R, Schreiber S, Byczkowski D, Li J, Kent JD, Pollack PF. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65. doi: 10.1053/j.gastro.2006.11.041. Epub 2006 Nov 29. |
| 25115149 | Background | Yassin NA, Askari A, Warusavitarne J, Faiz OD, Athanasiou T, Phillips RK, Hart AL. Systematic review: the combined surgical and medical treatment of fistulising perianal Crohn's disease. Aliment Pharmacol Ther. 2014 Oct;40(7):741-9. doi: 10.1111/apt.12906. Epub 2014 Aug 13. |
| 21083581 | Background | Tozer PJ, Burling D, Gupta A, Phillips RK, Hart AL. Review article: medical, surgical and radiological management of perianal Crohn's fistulas. Aliment Pharmacol Ther. 2011 Jan;33(1):5-22. doi: 10.1111/j.1365-2036.2010.04486.x. Epub 2010 Oct 29. |
| 19755971 | Background | Ng SC, Plamondon S, Gupta A, Burling D, Swatton A, Vaizey CJ, Kamm MA. Prospective evaluation of anti-tumor necrosis factor therapy guided by magnetic resonance imaging for Crohn's perineal fistulas. Am J Gastroenterol. 2009 Dec;104(12):2973-86. doi: 10.1038/ajg.2009.509. Epub 2009 Sep 15. |
| 22223472 | Background | Tozer P, Ng SC, Siddiqui MR, Plamondon S, Burling D, Gupta A, Swatton A, Tripoli S, Vaizey CJ, Kamm MA, Phillips R, Hart A. Long-term MRI-guided combined anti-TNF-alpha and thiopurine therapy for Crohn's perianal fistulas. Inflamm Bowel Dis. 2012 Oct;18(10):1825-34. doi: 10.1002/ibd.21940. Epub 2012 Jan 4. |
| 21945953 | Background | 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. |
| 28993262 | Background | Reenaers C, Mary JY, Nachury M, Bouhnik Y, Laharie D, Allez M, Fumery M, Amiot A, Savoye G, Altwegg R, Devos M, Malamut G, Bourreille A, Flourie B, Marteau P, Vuitton L, Coffin B, Viennot S, Lambert J, Colombel JF, Louis E; Groupe d'Etude Therapeutique des Affections Inflammatoires du tube Digestif. Outcomes 7 Years After Infliximab Withdrawal for Patients With Crohn's Disease in Sustained Remission. Clin Gastroenterol Hepatol. 2018 Feb;16(2):234-243.e2. doi: 10.1016/j.cgh.2017.09.061. Epub 2017 Oct 7. |
| 16305724 | Background | 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. |
| 23376316 | Background | Bouguen G, Siproudhis L, Gizard E, Wallenhorst T, Billioud V, Bretagne JF, Bigard MA, Peyrin-Biroulet L. Long-term outcome of perianal fistulizing Crohn's disease treated with infliximab. Clin Gastroenterol Hepatol. 2013 Aug;11(8):975-81.e1-4. doi: 10.1016/j.cgh.2012.12.042. Epub 2013 Jan 30. |
| 29733370 | Background | Legue C, Brochard C, Bessi G, Wallenhorst T, Dewitte M, Siproudhis L, Bouguen G. Outcomes of Perianal Fistulising Crohn's Disease Following Anti-TNFalpha Treatment Discontinuation. Inflamm Bowel Dis. 2018 May 18;24(6):1107-1113. doi: 10.1093/ibd/izy008. |
| 28981618 | Background | Mak WY, Lung PFC, Hart A. In Patients With Perianal Crohn's Fistulas, What Are the Outcomes When 'Radiological Healing' Is Achieved? Does Radiological Healing of Perianal Crohn's Fistulas Herald the Time Point for Stopping a Biologic? J Crohns Colitis. 2017 Dec 4;11(12):1506. doi: 10.1093/ecco-jcc/jjx094. No abstract available. |
| 27433143 | Background | Wei SC. Differences in the public medical insurance systems for inflammatory bowel disease treatment in Asian countries. Intest Res. 2016 Jul;14(3):218-23. doi: 10.5217/ir.2016.14.3.218. Epub 2016 Jun 27. |