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Crohn's DiseaseCREOLENCT01183403

CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease

An observational study of Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
How many people
80 participants
Where
18 sitesin 2 countries
Study dates
Jan 2010to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients with ileal Crohn's disease complicated by symptomatic stricture after failure of corticosteroids and/or immunosuppressives

Who may be able to join

  • Crohn's disease defined according to the usual endoscopic, histological, and radiological criteria
  • Small bowel (jejunum or ileum) stricture identified by radiography or endoscopy
  • Obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks
  • Failure of corticosteroids and/or immunosuppressives and indication for anti-TNF therapy

Who cannot join

  • Nonresolving complete bowel obstruction
  • Previous anti-TNF therapy
  • Contraindication to anti-TNF therapy:
  • Intra-abdominal, intra-mural or extramural abscess
  • Active infection
  • Severe infection during the previous 2 months
Show all 12Show fewer
  • Nontreated latent tuberculosis
  • Heart failure
  • Active malignancy during the previous 5 years
  • Demyelinating neurological disease
  • Modification of the treatment of Crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide
  • Contraindication to MR enterography or contrast-enhanced ultrasonography

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

France17 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon, 25030

  • Hopital Avicennes

    Bobigny, 93200

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94275

  • Chru Lille

    Lille, 59037

  • Chu Montpellier

    Montpellier, 34295

  • Chu Nantes

    Nantes, 44093

  • CHU NICE

    Nice, 06202

  • Hopital Lariboisiere

    Paris, 75010

  • Hopital Saint Louis

    Paris, 75010

  • Hopital St Antoine

    Paris, 75012

  • Hopital Cochin

    Paris, 75014

  • Hopital Bichat

    Paris, 75018

  • Chu Reims

    Reims, 51000

  • Chu Rouen

    Rouen, 76031

  • Chu Tours

    Tours, 37044

Other trials in France

Belgium1 site

  • Ulb - Clinique Saint Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Value of Contrast-enhanced Ultrasonography and Magnetic Resonance Enterography to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease Complicated by Symptomatic Small Bowel Stricture

The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.

In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.

The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.

Conditions
Crohn's Disease
Keywords
stricture, anti-TNF, ileal Crohn'Disease, patients with ileal Crohn's disease complicated by, symptomatic stricture after failure of corticosteroids, and/or immunosuppressives
Medical subject headings
Crohn Disease, Constriction, Pathologic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)

    Measured: 6 months minus baseline

Secondary outcomes (1)

  1. Change of the obstructive symptom scale at the various visits between D0 and W24

    Measured: 6 months minus baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01183403
Sponsor's protocol ID
GETAID 2008-3
Acronym
CREOLE
Status last verified
Jun 2015
First submitted
11 Sep 2009
Last updated
23 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bernstein CN, Greenberg H, Boult I, Chubey S, Leblanc C, Ryner L. A prospective comparison study of MRI versus small bowel follow-through in recurrent Crohn's disease. Am J Gastroenterol. 2005 Nov;100(11):2493-502. doi: 10.1111/j.1572-0241.2005.00239.x.

    PubMed 16279905

  • Biancone L, Calabrese E, Petruzziello C, Onali S, Caruso A, Palmieri G, Sica GS, Pallone F. Wireless capsule endoscopy and small intestine contrast ultrasonography in recurrence of Crohn's disease. Inflamm Bowel Dis. 2007 Oct;13(10):1256-65. doi: 10.1002/ibd.20199.

    PubMed 17577246

  • Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

    PubMed 18046031

  • Chiorean MV, Sandrasegaran K, Saxena R, Maglinte DD, Nakeeb A, Johnson CS. Correlation of CT enteroclysis with surgical pathology in Crohn's disease. Am J Gastroenterol. 2007 Nov;102(11):2541-50. doi: 10.1111/j.1572-0241.2007.01537.x. Epub 2007 Sep 26.

    PubMed 17900329

  • Esteban JM, Aleixandre A, Hurtado MJ, Maldonado L, Mora FJ, Nogues E. Contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses in Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):253-9. doi: 10.1097/00042737-200303000-00008.

    PubMed 12610320

  • Giorgio A, Ferraioli G, Tarantino L, de Stefano G, Scala V, Scarano F, Coppola C, Del Viscovo L. Contrast-enhanced sonographic appearance of hepatocellular carcinoma in patients with cirrhosis: comparison with contrast-enhanced helical CT appearance. AJR Am J Roentgenol. 2004 Nov;183(5):1319-26. doi: 10.2214/ajr.183.5.1831319.

    PubMed 15505297

  • Guidi L, De Franco A, De Vitis I, Armuzzi A, Semeraro S, Roberto I, Papa A, Bock E, Gasbarrini G, Fedeli G. Contrast-enhanced ultrasonography with SonoVue after infliximab therapy in Crohn's disease. Eur Rev Med Pharmacol Sci. 2006 Jan-Feb;10(1):23-6.

    PubMed 16494107

  • Holtmann M, Wanitschke R, Helisch A, Bartenstein P, Galle PR, Neurath M. [Anti-TNF antibodies in the treatment of inflammatory intestinal stenoses in Crohn's disease]. Z Gastroenterol. 2003 Jan;41(1):11-7. doi: 10.1055/s-2003-36677. German.

    PubMed 12541166

  • Louis E, Boverie J, Dewit O, Baert F, De Vos M, D'Haens G; Belgian IBD Research Group. Treatment of small bowel subocclusive Crohn's disease with infliximab: an open pilot study. Acta Gastroenterol Belg. 2007 Jan-Mar;70(1):15-9.

    PubMed 17619533

  • Masselli G, Brizi GM, Parrella A, Minordi LM, Vecchioli A, Marano P. Crohn disease: magnetic resonance enteroclysis. Abdom Imaging. 2004 May-Jun;29(3):326-34. doi: 10.1007/s00261-003-0116-9. No abstract available.

    PubMed 15354341

  • Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25.

    PubMed 17899102

  • Negaard A, Mulahasanovic A, Reisaeter LA, Aasekjaer K, Sandvik L, Klow NE. Crohn's disease evaluated with magnetic resonance enteroclysis: diagnostic performance of experienced and inexperienced readers before and after training. Acta Radiol. 2008 Nov;49(9):967-74. doi: 10.1080/02841850802409539.

    PubMed 18925449

  • Negaard A, Sandvik L, Mulahasanovic A, Berstad AE, Klow NE. Magnetic resonance enteroclysis in the diagnosis of small-intestinal Crohn's disease: diagnostic accuracy and inter- and intra-observer agreement. Acta Radiol. 2006 Dec;47(10):1008-16. doi: 10.1080/02841850600979071.

    PubMed 17135001

  • Parente F, Greco S, Molteni M, Anderloni A, Maconi G, Bianchi Porro G. Modern imaging of Crohn's disease using bowel ultrasound. Inflamm Bowel Dis. 2004 Jul;10(4):452-61. doi: 10.1097/00054725-200407000-00022.

    PubMed 15475759

  • De Pascale A, Garofalo G, Perna M, Priola S, Fava C. Contrast-enhanced ultrasonography in Crohn's disease. Radiol Med. 2006 Jun;111(4):539-50. doi: 10.1007/s11547-006-0049-9. Epub 2006 May 25. English, Italian.

    PubMed 16779540

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) (time frame: 6 months minus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01183403, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.

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