Clinical trial NCT01428843: Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Official title: A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease
Anemia
Anti-TNF alpha theray
Ferrisat perfusion
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.

Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.

The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
* Under anti-TNF therapy or indication for starting an anti-TNF therapy
* Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
* Iron deficiency anemia defined as:
* Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value

Exclusion Criteria:

-

Primary outcomes:
measure: Level of hemoglobin
timeFrame: 6 weeks after inclusion
Secondary outcomes:
measure: Tolerance of Ferrisat
timeFrame: At Inclusion
measure: Improvement of quality of life
timeFrame: 6 weeks after perfusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Caen
country: France
facility: CHU CAEN
city: Clermont-ferrand
country: France
facility: Chu Clermont-Ferrand
city: Clichy
country: France
facility: Hopital Beaujon
city: Le Kremlin Bicetre
country: France
facility: Hopital Bicetre
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Chu Marseille - Hopital Nord
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Pessac
country: France
facility: CHU Bordeaux - Pessac
city: Pierre Benite
country: France
facility: CHU LYON
city: Rennes
country: France
facility: Chu Rennes
city: Rouen
country: France
facility: Chu Rouen
city: St Etienne
country: France
facility: Chu Saint Etienne
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Guillaume SAVOYE, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Jean-Frédéric COLOMBEL, PhD
role: STUDY_DIRECTOR
References:
citation: Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. doi: 10.1046/j.1365-2036.2001.00930.x.
citation: Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.
citation: Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. doi: 10.1136/gut.8.2.107. No abstract available.
citation: Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. doi: 10.1016/j.amjmed.2003.12.011.
citation: Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53. doi: 10.1002/ibd.20285.
citation: Gisbert JP, Gomollon F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x.