Study Stopped
Lack of enrollment
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
FER
A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
2 other identifiers
interventional
60
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
September 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 23, 2015
June 1, 2015
3.9 years
August 30, 2011
June 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of hemoglobin
Efficacy of one-shot perfusion of Ferrisat (Iron supplementation)
6 weeks after inclusion
Secondary Outcomes (2)
Tolerance of Ferrisat
At Inclusion
Improvement of quality of life
6 weeks after perfusion
Study Arms (2)
Ferrisat
ACTIVE COMPARATORInfusion of Ferrisat (50mg/ml) at inclusion under usual practices
Placebo
PLACEBO COMPARATORInfusion of placebo at inclusion visit
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Chu Amiens
Amiens, 80054, France
CHU CAEN
Caen, 14033, France
Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
Hopital Beaujon
Clichy, 92110, France
Hopital Bicetre
Le Kremlin-Bicêtre, 94275, France
CHRU Lille
Lille, France
Chu Marseille - Hopital Nord
Marseille, 13915, France
Chu Nantes
Nantes, 44093, France
Hopital Saint Louis
Paris, 75010, France
Hopital St Antoine
Paris, 75012, France
Hopital Cochin
Paris, 75014, France
CHU Bordeaux - Pessac
Pessac, 33700, France
CHU LYON
Pierre-Bénite, 69495, France
Chu Rennes
Rennes, 35033, France
Chu Rouen
Rouen, 76031, France
Chu Saint Etienne
Saint-Etienne, 42270, France
Chu Toulouse
Toulouse, 31403, France
Chu Tours
Tours, 37044, France
Related Publications (6)
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.
PMID: 11284771BACKGROUNDVijverman 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.
PMID: 16673554BACKGROUNDOrmerod 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.
PMID: 6022337BACKGROUNDWilson 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.
PMID: 15050885RESULTGasche 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.
PMID: 17985376RESULTGisbert 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.
PMID: 18477354RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 5, 2011
Study Start
January 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 23, 2015
Record last verified: 2015-06