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

Inflammatory Bowel Disease Clinical Trial

— FER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01428843
• Other study ID #: GETAID 2009-2
• Secondary ID: 2009-011316-38
• Status: Terminated
• Phase: Phase 3
• First received: August 30, 2011
• Last updated: June 21, 2015
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• FERRISAT
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
• PLACEBO
A single infusion of Glucose 5% solution during inclusion visit

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	CHU CAEN	Caen
France	Chu Clermont-Ferrand	Clermont-ferrand
France	Hopital Beaujon	Clichy
France	Hopital Bicetre	Le Kremlin Bicetre
France	CHRU Lille	Lille
France	Chu Marseille - Hopital Nord	Marseille
France	Chu Nantes	Nantes
France	Hopital Cochin	Paris
France	Hopital Saint Louis	Paris
France	Hopital St Antoine	Paris
France	CHU Bordeaux - Pessac	Pessac
France	CHU LYON	Pierre Benite
France	Chu Rennes	Rennes
France	Chu Rouen	Rouen
France	Chu Saint Etienne	St Etienne
France	Chu Toulouse	Toulouse
France	Chu Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

References & Publications (6)

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 an — View Citation

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. doi: 10.1111/j.1572-0241.2008.01846.x. Review. — View 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. Review. — View Citation

Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of hemoglobin	Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)	6 weeks after inclusion	No
Secondary	Tolerance of Ferrisat		At Inclusion	Yes
Secondary	Improvement of quality of life		6 weeks after perfusion	No