Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

Completed

• Conditions: Autoimmune Hemolytic Anemia
• Interventions: Biological: blood sample; Procedure: spleen sample

• Registration Number: NCT02828670
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-07
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with a diagnosis of warm AIHA defined by

  • Hemoglobin <11 g/dl
  • Low haptoglobin level
  • Positive direct antiglobulin test (IgG or IgG + complement)
  • Reticulocyte count >120 G/L

• Patients

  • naive to treatment for hemolytic anemia or a in relapse
  • Older than 18 years
  • Able to understand written and spoken French

• Persons who have provided written consent

Control population

• Patients who have given consent
• Patients over 18 years
• Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls
• Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,...) can be included as a sub-group of controls

Exclusion Criteria

• Patients without national health insurance
• Pregnancy or breast-feeding women
• Adults under guardianship
• Patients with cancer or malignant hemopathy
• Patients with an on-going infection
• Patients treated with corticoids or immunosuppressants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	spleen sample	-
patient	blood sample	-
control	blood sample	-
control	spleen sample	-

Primary Outcome Measures

Name	Time	Method
the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids	through study completion, an average of 1 year
the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.	baseline

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France