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The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia. (ITP-RITUX)

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ClinicalTrials.gov Identifier: NCT01101295
Recruitment Status : Unknown
Verified March 2012 by Khellaf Mehdi, Henri Mondor University Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2010
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital

Study Description
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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.

Condition or disease
Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenia

Detailed Description:

Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.

Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
Study Start Date : April 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of a serious adverse events (clinical or biological events) [ Time Frame: 5 years ]
    reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...


Secondary Outcome Measures :
  1. Impact of rituximab on the natural history of ITP [ Time Frame: 5 years ]

    Number of patients in complete response (platelet count>100G/L), in partial response (platelet count>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP.

    Use of emergencies treatment for ITP.


  2. Modality of the administration of rituximab [ Time Frame: 5 years ]
    number of perfusions, dosage, retreatment.

  3. Characteristics of the patients receiving Rituximab [ Time Frame: 5 years ]
    age, sex, duration of ITP, previous used treatment

  4. Evaluation of the Platelet count evolution [ Time Frame: 5 years ]
    Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.

  5. Rate of splenectomy in the cohort [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101295


Contacts
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Contact: Bertrand GODEAU, MD 0033149812900 bertrand.godeau@hmn.aphp.fr
Contact: Mehdi KHELLAF, MD 0033149812076 mehdi.khellaf@hmn.aphp.fr

Locations
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France
Henri Mondor University Hospital Recruiting
Creteil, Val de Marne, France, 94010
Contact: Mehdi KHELLAF, MD    0033149812076    mehdi.khellaf@hmn.aphp.fr   
Sub-Investigator: Mehdi KHELLAF, MD         
National Reference Center for the Study of Auto Immune Cytopenia Recruiting
Creteil, Val de Marne, France, 94010
Contact: Mehdi KHELLAF, MD    0033149812076    mehdi.khellaf@hmn.aphp.fr   
Sponsors and Collaborators
Henri Mondor University Hospital
Roche Pharma AG
Investigators
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Principal Investigator: Bertrand GODEAU, MD National Reference Center for Study of Cytopenia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Khellaf Mehdi, Medical Doctor, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01101295    
Other Study ID Numbers: GECAI
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: March 21, 2012
Last Verified: March 2012
Keywords provided by Khellaf Mehdi, Henri Mondor University Hospital:
Immune Thrombocytopenia
Rituximab
side effects
tolerance
 safety
splenectomy
serum sickness
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
 Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases