Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Inflammatory Bowel Disease	Drug: Ferric oxide, saccharated Drug: Glucose 5% solution	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Ferric oxide Dextrose

U.S. FDA Resources

Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:

Level of hemoglobin [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)

Secondary Outcome Measures:

Tolerance of Ferrisat [ Time Frame: At Inclusion ] [ Designated as safety issue: Yes ]
Improvement of quality of life [ Time Frame: 6 weeks after perfusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	January 2011
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Ferrisat Infusion of Ferrisat (50mg/ml) at inclusion under usual practices	Drug: Ferric oxide, saccharated A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Placebo Comparator: Placebo Infusion of placebo at inclusion visit	Drug: Glucose 5% solution A single infusion of Glucose 5% solution during inclusion visit

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428843

Locations

France
Chu Amiens	Active, not recruiting
Amiens, France, 80054
CHU CAEN	Not yet recruiting
Caen, France, 14033
Contact: Jean-Marie REIMUND, MD,PhD +33231064540 reimund-jm@chu-caen.fr
Principal Investigator: Jean-Marie REIMUND, MD,PhD
Chu Clermont-Ferrand	Recruiting
Clermont-ferrand, France, 63003
Contact: Gilles BOMMELAER, MD,PhD +33473750523 gbommelaer@chu-clermontferrand.fr
Principal Investigator: Gilles BOMMELAER, MD,PhD
Hopital Beaujon	Active, not recruiting
Clichy, France, 92110
Hopital Bicetre	Active, not recruiting
Le Kremlin Bicetre, France, 94275
CHRU Lille	Active, not recruiting
Lille, France
Chu Marseille - Hopital Nord	Recruiting
Marseille, France, 13915
Contact: Jean-Charles GRIMAUD, MD,PhD +33491968737 jean-charles.grimaud@mail.ap-hm.fr
Principal Investigator: Jean-Charles GRIMAUD, MD,PhD
Chu Nantes	Recruiting
Nantes, France, 44093
Contact: Arnaud BOURREILLE, MD +33202400830 arnaud.boureille@chu-nantes.fr
Principal Investigator: Arnaud BOURREILLE, MD
Sub-Investigator: Mathurin FLAMANT, MD
Hopital St Antoine	Not yet recruiting
Paris, France, 75012
Contact: Jacques COSNES, MD, PhD +33 1 49 28 31 70 jacques.cosnes@sat.aphp.fr
Principal Investigator: Jacques COSNES, MD, PhD
Sub-Investigator: Philippe SEKSIK, PhD
Sub-Investigator: Laurent BEAUGERIE, MD, PhD
Hopital Cochin	Recruiting
Paris, France, 75014
Contact: Vered ABITBOL, MD +33158411967 vered@club-internet.fr
Sub-Investigator: Stanislas CHAUSSADE, MD,PhD
Principal Investigator: Vered ABITBOL, MD
Hopital Saint Louis	Active, not recruiting
Paris, France, 75010
CHU Bordeaux - Pessac	Recruiting
Pessac, France, 33700
Contact: David LAHARIE, MD david.laharie@chu-bordeaux.fr
Contact: Sylvie RAZAIRE sylvie.razaire@chu-bordeaux.fr
Principal Investigator: David LAHARIE, MD
CHU LYON	Not yet recruiting
Pierre Benite, France, 69495
Contact: Bernard FLOURIE, MD,PhD +33478861288 bernard.flourie@chu-lyon.fr
Principal Investigator: Bernard FLOURIE, MD,PhD
Sub-Investigator: Stéphane NANCEY, PhD
Chu Rennes	Recruiting
Rennes, France, 35033
Contact: Guillaume BOUGUEN, MD +33299284347 guillaume.bouguen@chu-rennes.fr
Sub-Investigator: Laurent SIPROUDHIS, MD,PhD
Chu Rouen	Recruiting
Rouen, France, 76031
Contact: Eric LEREBOURS, MD,PhD +33232888101 eric.lerebours@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr
Sub-Investigator: Eric LEREBOURS, MD,PhD
Principal Investigator: Guillaume SAVOYE, PhD
Chu Saint Etienne	Active, not recruiting
St Etienne, France, 42270
Chu Toulouse	Active, not recruiting
Toulouse, France, 31403
Chu Tours	Active, not recruiting
Tours, France, 37044

Sponsors and Collaborators

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

Principal Investigator:	Guillaume SAVOYE, PhD	GETAID
Study Director:	Jean-Frédéric COLOMBEL, PhD	GETAID

More Information

Publications:

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. Review.

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.

Gisbert JP, Gomollón F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. Review.

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. Review.

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.

Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. No abstract available.

Responsible Party:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:	NCT01428843 History of Changes
Other Study ID Numbers:	GETAID 2009-2, 2009-011316-38
Study First Received:	August 30, 2011
Last Updated:	April 23, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Inflammatory Bowel Disease
Anemia
Anti-TNF alpha theray
Ferrisat perfusion

Additional relevant MeSH terms:

Anemia
Inflammatory Bowel Diseases
Intestinal Diseases
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

Ferric oxide, saccharated
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy (FER)