NCT01101295

Brief Summary

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

April 5, 2010

Last Update Submit

March 20, 2012

Conditions

Purpura, Thrombocytopenic, IdiopathicAutoimmune Thrombocytopenia

Keywords

Immune ThrombocytopeniaRituximabside effectstolerancesafetysplenectomyserum sickness

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a serious adverse events (clinical or biological events)

    reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...

    5 years

Secondary Outcomes (5)

  • Impact of rituximab on the natural history of ITP

    5 years

  • Modality of the administration of rituximab

    5 years

  • Characteristics of the patients receiving Rituximab

    5 years

  • Evaluation of the Platelet count evolution

    5 years

  • Rate of splenectomy in the cohort

    5 years

Eligibility Criteria

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

Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).

You may qualify if:

  • ITP diagnosis according to the American Society of Hematology society
  • Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)

You may not qualify if:

  • Previous treatment by rituximab
  • Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
  • Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henri Mondor University Hospital

Créteil, Val de Marne, 94010, France

RECRUITING

National Reference Center for the Study of Auto Immune Cytopenia

Créteil, Val de Marne, 94010, France

RECRUITING

Related Publications (1)

  • Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.

    PMID: 25293768DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicSerum Sickness

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 SymptomsDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Bertrand GODEAU, MD

    National Reference Center for Study of Cytopenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand GODEAU, MD

CONTACT

0033149812900bertrand.godeau@hmn.aphp.fr

Mehdi KHELLAF, MD

CONTACT

0033149812076mehdi.khellaf@hmn.aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 9, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2017

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations

FR(2)