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

Primary Purpose

Inflammatory Bowel Disease

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
FERRISAT
PLACEBO
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Chu Amiens
  • CHU CAEN
  • Chu Clermont-Ferrand
  • Hopital Beaujon
  • Hopital Bicetre
  • CHRU Lille
  • Chu Marseille - Hopital Nord
  • Chu Nantes
  • Hopital Saint Louis
  • Hopital St Antoine
  • Hopital Cochin
  • CHU Bordeaux - Pessac
  • CHU LYON
  • Chu Rennes
  • Chu Rouen
  • Chu Saint Etienne
  • Chu Toulouse
  • Chu Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ferrisat

Placebo

Arm Description

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

Infusion of placebo at inclusion visit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance of Ferrisat
Improvement of quality of life

Full Information

First Posted
August 30, 2011
Last Updated
June 21, 2015
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT01428843
Brief Title
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Inflammatory Bowel Disease, Anemia, Anti-TNF alpha theray, Ferrisat perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrisat
Arm Type
Active Comparator
Arm Description
Infusion of Ferrisat (50mg/ml) at inclusion under usual practices
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Infusion of placebo at inclusion visit
Intervention Type
Drug
Intervention Name(s)
FERRISAT
Other Intervention Name(s)
ACTIVE FERRISAT
Intervention Description
A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Other Intervention Name(s)
GLUCOSE 5%
Intervention Description
A single infusion of Glucose 5% solution during inclusion visit
Primary Outcome Measure Information:
Title
Level of hemoglobin
Description
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)
Time Frame
6 weeks after inclusion
Secondary Outcome Measure Information:
Title
Tolerance of Ferrisat
Time Frame
At Inclusion
Title
Improvement of quality of life
Time Frame
6 weeks after perfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume SAVOYE, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Frédéric COLOMBEL, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Study Director
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chu Clermont-Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
Chu Marseille - Hopital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital St Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Bordeaux - Pessac
City
Pessac
ZIP/Postal Code
33700
Country
France
Facility Name
CHU LYON
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Chu Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Chu Saint Etienne
City
St Etienne
ZIP/Postal Code
42270
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11284771
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. doi: 10.1046/j.1365-2036.2001.00930.x.
Results Reference
background
PubMed Identifier
16673554
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.
Results Reference
background
PubMed Identifier
6022337
Citation
Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14. doi: 10.1136/gut.8.2.107. No abstract available.
Results Reference
background
PubMed Identifier
15050885
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. doi: 10.1016/j.amjmed.2003.12.011.
Results Reference
result
PubMed Identifier
17985376
Citation
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 and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53. doi: 10.1002/ibd.20285.
Results Reference
result
PubMed Identifier
18477354
Citation
Gisbert JP, Gomollon 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.
Results Reference
result

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

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