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WithdrawnNCT04129723Updated Jan 28, 2022

Stopping Biological Therapy in PCD Study

An interventional study of Stopping biological therapy in Perianal Crohn Disease, MRI and Biological Therapy, sponsored by Chinese University of Hong Kong. Withdrawn at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No suitable case identified
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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

02

Conditions studied

  • Perianal Crohn Disease
  • MRI
  • Biological Therapy

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Keywords

  • pCD
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

Browse Crohn Disease studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Perianal Crohn's patient

    Stopping biological therapy

    Other: Stopping biological therapy

Interventions

  • OtherStopping biological therapy

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

06

What researchers measure

Primary outcomes

  1. Rate of perianal Crohn's disease relapse within 12 months after stopping

    Relapse rate of patient will be calculated

    Time frame: 12 months

Secondary outcomes

  1. Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy

    Relapse rate of patient will be calculated

    Time frame: 12 months

  2. Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse

    Relapse rate of patient will be calculated

    Time frame: 12 months

  3. Factors associated with relapse of perianal Crohn's disease after stopping biological therapy

    Factors associated factors will be measured by questionnaire and clinical assessment

    Time frame: 12 months

  4. Factors associated with relapse of luminal Crohn's disease after stopping biological therapy

    Factors associated factors will be measured by questionnaire and clinical assessment

    Time frame: 12 months

07

Study locations

1 site
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong
08

References and documents

Publications

  • 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. PubMed 30165543 ↗
  • 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. PubMed 16530505 ↗
  • 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. PubMed 14985485 ↗
  • 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. PubMed 17241859 ↗
  • 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. PubMed 25115149 ↗
  • 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. PubMed 21083581 ↗
  • 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. PubMed 19755971 ↗
  • 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. PubMed 22223472 ↗
  • 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. PubMed 21945953 ↗
  • 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. PubMed 28993262 ↗
  • 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. PubMed 16305724 ↗
  • 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. PubMed 23376316 ↗
  • 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. PubMed 29733370 ↗
  • 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. PubMed 28981618 ↗
  • 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. PubMed 27433143 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04129723
Lead sponsor
Chinese University of Hong Kong
Responsible party
Mak Wing Yan (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Oct 17, 2019
Start date
Jan 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 28, 2022

Study contacts

Wing Yan Mak, MRCP
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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