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

Phase 3

Terminated

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: PLACEBO; Drug: FERRISAT

• Registration Number: NCT01428843
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PLACEBO	Infusion of placebo at inclusion visit
Ferrisat	FERRISAT	Infusion of Ferrisat (50mg/ml) at inclusion under usual practices

Primary Outcome Measures

Name	Time	Method
Level of hemoglobin	6 weeks after inclusion	Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)

Secondary Outcome Measures

Name	Time	Method
Improvement of quality of life	6 weeks after perfusion
Tolerance of Ferrisat	At Inclusion

Trial Locations

Locations (18)

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 Saint Louis; 🇫🇷 Paris, France

Hopital St Antoine; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

CHU Bordeaux - Pessac; 🇫🇷 Pessac, France

CHU LYON; 🇫🇷 Pierre Benite, France

Chu Rennes; 🇫🇷 Rennes, France

Chu Rouen; 🇫🇷 Rouen, France

Chu Tours; 🇫🇷 Tours, France

Chu Saint Etienne; 🇫🇷 St Etienne, France

Chu Toulouse; 🇫🇷 Toulouse, France