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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01428843
First received: August 30, 2011
Last updated: July 16, 2014
Last verified: July 2014
  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:


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 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Director: Jean-Frédéric COLOMBEL, PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  More Information

Publications:
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: July 16, 2014
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:
Inflammatory Bowel Diseases
Anemia
Intestinal Diseases
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pharmaceutical Solutions
Ferric oxide, saccharated
Ferric Compounds
Therapeutic Uses
Pharmacologic Actions
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on August 01, 2014