Stopping Biological Therapy in PCD Study

MRI Clinical Trial

Official title:

Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04129723
• Other study ID #: STOP-PCD
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

Description:

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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. At least 18 years old 2. Have a confirmed diagnosis of perianal Crohn's disease according to established clinical, endoscopic, radiological and histologic criteria 3. On biological therapy (anti-tumour necrosis factor, anti-integrin, anti-IL12/23) for at least 6 months 4. Confirmation of radiologically healed perianal Crohn's fistulas on MRI pelvis within the past 12 months by experienced radiologists 5. In steroid-free clinical remission for at least 6 months with fecal calprotectin <250 µg/g 6. Stable doses of immunosuppressants for at least 3 months if immunosuppressants are used 7. Written informed consent

Exclusion Criteria:

• 1. History of severe acute or delayed infusion reaction to biological therapy 2. Fistulising Crohn's disease to organs other than perianal Crohn's fistula (fistulation to skin, intestines, bladder etc.) 3. Prior history of diverting ileostomy, colostomy, proctocolectomy or proctectomy 4. Known pregnancy 5. Terminal illness

Related Conditions & MeSH terms

• Biological Therapy
• Crohn Disease
• MRI
• Perianal Crohn Disease

Intervention

Other:
• Stopping biological therapy
Stopping biological therapy The primary endpoint is clinical relapse at 12 months

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (15)

Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. — View Citation

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. — View Citation

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. Epub 2006 Nov 29. — View Citation

Domènech E, Hinojosa J, Nos P, Garcia-Planella E, Cabré 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. — View Citation

Legué C, Brochard C, Bessi G, Wallenhorst T, Dewitte M, Siproudhis L, Bouguen G. Outcomes of Perianal Fistulising Crohn's Disease Following Anti-TNFa Treatment Discontinuation. Inflamm Bowel Dis. 2018 May 18;24(6):1107-1113. doi: 10.1093/ibd/izy008. — View Citation

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 Thérapeutiques 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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-a 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of perianal Crohn's disease relapse within 12 months after stopping	Relapse rate of patient will be calculated	12 months
Secondary	Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy	Relapse rate of patient will be calculated	12 months
Secondary	Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse	Relapse rate of patient will be calculated	12 months
Secondary	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
Secondary	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