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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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:

-