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

This study has been terminated.
(Lack of enrollment)
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: June 21, 2015
Last verified: June 2015
  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: FERRISAT
Drug: PLACEBO
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 ]

Enrollment: 60
Study Start Date: January 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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: FERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Other Name: ACTIVE FERRISAT
Placebo Comparator: Placebo
Infusion of placebo at inclusion visit
Drug: PLACEBO
A single infusion of Glucose 5% solution during inclusion visit
Other Name: GLUCOSE 5%

  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
Amiens, France, 80054
CHU CAEN
Caen, France, 14033
Chu Clermont-Ferrand
Clermont-ferrand, France, 63003
Hopital Beaujon
Clichy, France, 92110
Hopital Bicetre
Le Kremlin Bicetre, France, 94275
CHRU Lille
Lille, France
Chu Marseille - Hopital Nord
Marseille, France, 13915
Chu Nantes
Nantes, France, 44093
Hopital St Antoine
Paris, France, 75012
Hopital Cochin
Paris, France, 75014
Hopital Saint Louis
Paris, France, 75010
CHU Bordeaux - Pessac
Pessac, France, 33700
CHU LYON
Pierre Benite, France, 69495
Chu Rennes
Rennes, France, 35033
Chu Rouen
Rouen, France, 76031
Chu Saint Etienne
St Etienne, France, 42270
Chu Toulouse
Toulouse, France, 31403
Chu Tours
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: June 21, 2015
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
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 27, 2015