Crohn's Disease Clinical Trial
— CREOLEOfficial 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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ulb - Clinique Saint Luc | Bruxelles | |
| France | Chu Amiens | Amiens | |
| France | Chu Besancon | Besancon | |
| France | Hopital Avicennes | Bobigny | |
| France | Hopital Beaujon | Clichy | |
| France | Hopital Bicetre | Le Kremlin Bicetre | |
| France | Chru Lille | Lille | |
| France | Chu Montpellier | Montpellier | |
| France | Chu Nantes | Nantes | |
| France | CHU NICE | Nice | |
| France | Hopital Bichat | Paris | |
| France | Hopital Cochin | Paris | |
| France | Hopital Lariboisiere | Paris | |
| France | Hopital Saint Louis | Paris | |
| France | Hopital St Antoine | Paris | |
| France | Chu Reims | Reims | |
| France | Chu Rouen | Rouen | |
| France | Chu Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
Belgium, France,
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. — View Citation
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. — View Citation
Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review. — View Citation
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. Epub 2007 Sep 26. — View Citation
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. Epub 2006 May 25. English, Italian. — View Citation
Di Sabatino A, Fulle I, Ciccocioppo R, Ricevuti L, Tinozzi FP, Tinozzi S, Campani R, Corazza GR. Doppler enhancement after intravenous levovist injection in Crohn's disease. Inflamm Bowel Dis. 2002 Jul;8(4):251-7. — View Citation
Di Sabatino A, Pender SL, Jackson CL, Prothero JD, Gordon JN, Picariello L, Rovedatti L, Docena G, Monteleone G, Rampton DS, Tonelli F, Corazza GR, MacDonald TT. Functional modulation of Crohn's disease myofibroblasts by anti-tumor necrosis factor antibodies. Gastroenterology. 2007 Jul;133(1):137-49. Epub 2007 May 5. — View Citation
Esteban JM, Aleixandre A, Hurtado MJ, Maldonado L, Mora FJ, Nogués 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. — View Citation
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. — View Citation
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. — View Citation
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. German. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2007 Sep 25. — View Citation
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. — View Citation
Negaard A, Sandvik L, Mulahasanovic A, Berstad AE, Klöw 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. — View Citation
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. Review. — View Citation
Pelletier AL, Kalisazan B, Wienckiewicz J, Bouarioua N, Soulé JC. Infliximab treatment for symptomatic Crohn's disease strictures. Aliment Pharmacol Ther. 2009 Feb 1;29(3):279-85. doi: 10.1111/j.1365-2036.2008.03887.x. Epub 2008 Nov 8. — View Citation
Rieder F, Brenmoehl J, Leeb S, Schölmerich J, Rogler G. Wound healing and fibrosis in intestinal disease. Gut. 2007 Jan;56(1):130-9. Review. — View Citation
Sallomi DF. The use of contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses associated with Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):249-51. Review. — View Citation
Schlottmann K, Kratzer W, Schölmerich J. Doppler ultrasound and intravenous contrast agents in gastrointestinal tract disorders: current role and future implications. Eur J Gastroenterol Hepatol. 2005 Mar;17(3):263-75. Review. — View Citation
Schreyer AG, Geissler A, Albrich H, Schölmerich J, Feuerbach S, Rogler G, Völk M, Herfarth H. Abdominal MRI after enteroclysis or with oral contrast in patients with suspected or proven Crohn's disease. Clin Gastroenterol Hepatol. 2004 Jun;2(6):491-7. — View Citation
Serra C, Menozzi G, Labate AM, Giangregorio F, Gionchetti P, Beltrami M, Robotti D, Fornari F, Cammarota T. Ultrasound assessment of vascularization of the thickened terminal ileum wall in Crohn's disease patients using a low-mechanical index real-time scanning technique with a second generation ultrasound contrast agent. Eur J Radiol. 2007 Apr;62(1):114-21. Epub 2007 Jan 18. — View Citation
Solt J, Hertelendi A, Szilágyi K. [Balloon catheter dilatation of lower gastrointestinal tract stenoses: long-term results]. Orv Hetil. 2002 Aug 4;143(31):1835-40. Hungarian. — View Citation
Sorrentino D. Role of biologics and other therapies in stricturing Crohn's disease: what have we learnt so far? Digestion. 2008;77(1):38-47. doi: 10.1159/000117306. Epub 2008 Feb 19. Review. — View Citation
Warnaar N, Hofker HS, Maathuis MH, Niesing J, Bruggink AH, Dijkstra G, Ploeg RJ, Schuurs TA. Matrix metalloproteinases as profibrotic factors in terminal ileum in Crohn's disease. Inflamm Bowel Dis. 2006 Sep;12(9):863-9. — View Citation
* Note: There are 26 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..) | 6 months minus baseline | No | |
| Secondary | Change of the obstructive symptom scale at the various visits between D0 and W24 | 6 months minus baseline | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
| Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
| Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
| Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
| Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
| Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
| Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
| Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
| Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
| Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
| Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
| Completed |
NCT01958827 -
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
|
Phase 3 |