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

This study is currently recruiting participants.

Verified April 2012 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: April 23, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2011

Last Updated Date

April 23, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Level of hemoglobin [ Time Frame: 6 weeks after inclusion ] [ Designated as safety issue: No ]

Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01428843 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Inflammatory Bowel Disease

Intervention ^ICMJE

Drug: Ferric oxide, saccharated
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Drug: Glucose 5% solution
A single infusion of Glucose 5% solution during inclusion visit

Study Arm (s)

Active Comparator: Ferrisat
Infusion of Ferrisat (50mg/ml) at inclusion under usual practices

Intervention: Drug: Ferric oxide, saccharated
Placebo Comparator: Placebo
Infusion of placebo at inclusion visit

Intervention: Drug: Glucose 5% solution

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

132

Estimated Completion Date

September 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01428843

Other Study ID Numbers ^ICMJE

GETAID 2009-2, 2009-011316-38

Has Data Monitoring Committee

Responsible Party

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Sponsor ^ICMJE

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Guillaume SAVOYE, PhD	GETAID
Study Director:	Jean-Frédéric COLOMBEL, PhD	GETAID

Information Provided By

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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