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

A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Drug: FERRISAT; Drug: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens
  • Caen, France, 14033
    • CHU Caen
  • Clermont-ferrand, France, 63003
    • CHU Clermont-Ferrand
  • Clichy, France, 92110
    • Hopital Beaujon
  • Le Kremlin Bicetre, France, 94275
    • Hôpital Bicêtre
  • Lille, France
    • CHRU Lille
  • Marseille, France, 13915
    • CHU Marseille - Hopital Nord
  • Nantes, France, 44093
    • CHU Nantes
  • Paris, France, 75010
    • Hôpital Saint Louis
  • Paris, France, 75014
    • Hopital Cochin
  • Paris, France, 75012
    • Hopital St Antoine
  • Pessac, France, 33700
    • CHU Bordeaux - Pessac
  • Pierre Benite, France, 69495
    • CHU Lyon
  • Rennes, France, 35033
    • CHU Rennes
  • Rouen, France, 76031
    • CHU Rouen
  • St Etienne, France, 42270
    • CHU Saint Etienne
  • Toulouse, France, 31403
    • CHU Toulouse
  • Tours, France, 37044
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ferrisat; Infusion of Ferrisat (50mg/ml) at inclusion under usual practices	Drug: FERRISAT; A single infusion of 50 mg/ml of Ferrisat during inclusion visit.; Other Names: ACTIVE FERRISAT
PLACEBO_COMPARATOR: Placebo; Infusion of placebo at inclusion visit	Drug: PLACEBO; A single infusion of Glucose 5% solution during inclusion visit; Other Names: GLUCOSE 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of hemoglobin	Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)	6 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerance of Ferrisat	At Inclusion
Improvement of quality of life	6 weeks after perfusion

Collaborators and Investigators

• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Investigators: Principal Investigator: Guillaume SAVOYE, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives; Study Director: Jean-Frédéric COLOMBEL, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1136/gut.8.2.107. No abstract available.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: September 2, 2011
• First Posted (ESTIMATE): September 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Anemia; Inflammatory Bowel Disease; Anti-TNF alpha theray; Ferrisat perfusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Anemia; Intestinal Diseases
• Other Study ID Numbers: GETAID 2009-2; 2009-011316-38 (EUDRACT_NUMBER)