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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Terminated; Phase 3

Conditions: Inflammatory Bowel Disease

Treatments: Drug: FERRISAT; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT01428843

2009-011316-38 (EudraCT Number)

GETAID 2009-2

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Ferrisat

Active Comparator group

Description:

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

Treatment:

Drug: FERRISAT

Placebo

Placebo Comparator group

Description:

Infusion of placebo at inclusion visit

Treatment:

Drug: PLACEBO