NCT02877706

Brief Summary

CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Jun 2013Dec 2029

Study Start

First participant enrolled

June 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

13.5 years

First QC Date

July 2, 2016

Last Update Submit

December 23, 2025

Conditions

Immune ThrombocytopeniaAutoimmune Hemolytic Anemia

Keywords

Registry

Outcome Measures

Primary Outcomes (2)

  • Incidence of Immune thrombocytopenia (ITP) and AIHA

    Number of new cases

    Baseline

  • Natural evolution and events

    Disease duration. Description of bleeding, infection, thrombosis events

    Baseline and follow-up

Secondary Outcomes (8)

  • Response

    15 years

  • Complete rate

    15 years

  • Treatment lines

    15 years

  • Adverse drug reactions

    15 years

  • Bleeding

    15 years

  • +3 more secondary outcomes

Interventions

no specific interventionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multicentric adult ITP and AIHA case recording in France, selected in centers of the French Referral Autoimmune Cytopenia Network. Both secondary and tertiary (referral) centers are participating (N=44).

You may qualify if:

  • adult patients (18+ year-old)
  • newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

You may not qualify if:

  • \- opposition to data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Interne

Toulouse, 31000, France

RECRUITING

Related Publications (1)

  • Larue M, Moulis G, Rueter M, Audia S, Comont T, Terriou L, Viallard JF, Pan-Petesch B, Royer B, Bonnotte B, Galicier L, Lambotte O, Lefrere F, Cheze S, Ebbo M, Duong TA, Boutin E, Languille L, Mahevas M, Godeau B, Canoui-Poitrine F, Michel M. Efficacy and safety of dapsone in adult primary immune thrombocytopenia. Blood Adv. 2025 Apr 22;9(8):1976-1983. doi: 10.1182/bloodadvances.2024014939.

    PMID: 39874521DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicAnemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsAnemia, HemolyticAnemia

Study Officials

  • Moulis Guillaume, MD PhD

    University Hopsital Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moulis Guillaume, MD PhD

CONTACT

moulis.g@chu-toulouse.fr

Johanne Germain, PhD

CONTACT

johanne.germain@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2016

First Posted

August 24, 2016

Study Start

June 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2029

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

FR(1)