To Örebro University

oru.seÖrebro University Publications
System disruptions
We are currently experiencing disruptions on the search portals due to high traffic. We are working to resolve the issue, you may temporarily encounter an error message.
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis: the PROCTRIAL Consensus
Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France.
Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA.
Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada.
Show others and affiliations
2022 (English)In: Clinical Gastroenterology and Hepatology, ISSN 1542-3565, E-ISSN 1542-7714, Vol. 20, no 11, p. 2169-2627.e1Article in journal (Refereed) Published
Abstract [en]

BACKGROUND AND AIMS: Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the PROCTRIAL (Definition and endpoints for ulcerative PROCtitis in clinical TRIALs) initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults.

METHODS: Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.

RESULTS: The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity is proposed. Secondary endpoints which should be evaluated include endoscopic remission, histological remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.

CONCLUSION: In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the PROCTRIAL consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.

Place, publisher, year, edition, pages
Elsevier, 2022. Vol. 20, no 11, p. 2169-2627.e1
Keywords [en]
Consensus, definition, endpoint, ulcerative proctitis
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-97625DOI: 10.1016/j.cgh.2022.02.032ISI: 000931890100026PubMedID: 35189386Scopus ID: 2-s2.0-85132674590OAI: oai:DiVA.org:oru-97625DiVA, id: diva2:1639611
Funder
Pfizer ABAstraZeneca
Note

Funding agencies:

Prometheus 

Takeda Pharmaceutical Company Ltd  

AbbVie 

Johnson & Johnson USA Janssen Biotech Inc  

Amgen 

Arena Pharmaceuticals 

Biogen

Boehringer Ingelheim

Bristol-Myers Squibb Celgene Corporation  

Celltrion 

Cosmos Pharmaceuticals 

Eisai Co Ltd  

Elan 

Eli Lilly 

Ferring Pharmaceuticals  

Galapagos NV  

Fresenius Kabi 

Roche Holding Genentech  

Gilead Sciences 

GlaxoSmithKline  

Merck & Company  

Mylan 

Dexcel Pharma  

Progenity

Protagonist Therapeutics

Roche Holding  

Novartis  

Satisfai Health

Sublimity Therapeutics

Janssen Ortho

LLC

Prometheus Biosciences

Microba

Bristol-Myers Squibb  

Focus Medical

Theravance Biopharma RD

Calibr

Capella Bioscience

Celltrion Healthcare

ClostraBio

Enthera

Hoffmann-La Roche  

Gilead Sciences  

GlaxoSmithKline  

GossamerBio

Immunic

Index Pharmaceuticals

Innovation Pharmaceuticals

Ironwood Pharmaceuticals

Kaleido

Kallyope

MiroBio

Morphic Therapeutic

OSE Immunotherapeutics

Otsuka Pharmaceutical  

Palatin Technologies

Prometheus Laboratories

Pharmaceuticals

Seres Therapeutics

Sienna Biopharmaceuticals

Sun Pharma

Surrozen

LLC (HCP Live Institutional Perspectives in GI)

Teva Pharmaceutical Industries  

Thelium

Theravance Biopharma RD

TLL Pharma

USWM Enterprises

Ventyx Biosciences

Viela Bio

Vivante Health

Vivelix Pharmaceuticals

Bacainn Therapeutics

Boehringer Ingelheim  

Boston Pharmaceuticals

Q32 Bio

Redhill Biopharma

Rheos Medicines

Salix Pharmaceuticals

Cambridge Healthcare

Food Industries Organiszation

Janssen Nestle

Randox Laboratories  

Roche Holding Genentech  

Sublimity 

Wild Bio 

Innate Pharma 

MSD 

Astelas 

Nestle SA  

Aesca 

Centocor 

Falk Pharma GmbH 

Immundiagnostik 

Ardeypharm 

Augurix 

Calypso 

Available from: 2022-02-22 Created: 2022-02-22 Last updated: 2025-02-11Bibliographically approved

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full textPubMedScopus

Authority records

Halfvarson, Jonas

Search in DiVA

By author/editor
Halfvarson, Jonas
By organisation
School of Medical Sciences
In the same journal
Clinical Gastroenterology and Hepatology
Gastroenterology and Hepatology

Search outside of DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 96 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf