The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia. (ITP-RITUX)
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| ClinicalTrials.gov Identifier: NCT01101295 |
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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
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| Condition or disease |
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| Purpura, Thrombocytopenic, Idiopathic Autoimmune Thrombocytopenia |
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 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 |
- Occurrence of a serious adverse events (clinical or biological events) [ Time Frame: 5 years ]reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
- 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.
- Modality of the administration of rituximab [ Time Frame: 5 years ]number of perfusions, dosage, retreatment.
- Characteristics of the patients receiving Rituximab [ Time Frame: 5 years ]age, sex, duration of ITP, previous used treatment
- 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.
- Rate of splenectomy in the cohort [ Time Frame: 5 years ]
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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 |
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)
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
| Contact: Bertrand GODEAU, MD | 0033149812900 | bertrand.godeau@hmn.aphp.fr | |
| Contact: Mehdi KHELLAF, MD | 0033149812076 | mehdi.khellaf@hmn.aphp.fr |
| 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 | |
| Principal Investigator: | Bertrand GODEAU, MD | National Reference Center for Study of Cytopenia |
| 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 |
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Immune Thrombocytopenia Rituximab side effects tolerance |
safety splenectomy serum sickness |
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Thrombocytopenia Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders |
Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases |