The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia. (ITP-RITUX)
The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Val de Marne
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Creteil, Val de Marne, Francia, 94010
- Reclutamento
- Henri Mondor University Hospital
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Contatto:
- Mehdi KHELLAF, MD
- Numero di telefono: 0033149812076
- Email: mehdi.khellaf@hmn.aphp.fr
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Sub-investigatore:
- Mehdi KHELLAF, MD
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Creteil, Val de Marne, Francia, 94010
- Reclutamento
- National Reference Center for the Study of Auto Immune Cytopenia
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Contatto:
- Mehdi KHELLAF, MD
- Numero di telefono: 0033149812076
- Email: mehdi.khellaf@hmn.aphp.fr
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occurrence of a serious adverse events (clinical or biological events)
Lasso di tempo: 5 years
|
reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
|
5 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Impact of rituximab on the natural history of ITP
Lasso di tempo: 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. |
5 years
|
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Modality of the administration of rituximab
Lasso di tempo: 5 years
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number of perfusions, dosage, retreatment.
|
5 years
|
|
Characteristics of the patients receiving Rituximab
Lasso di tempo: 5 years
|
age, sex, duration of ITP, previous used treatment
|
5 years
|
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Evaluation of the Platelet count evolution
Lasso di tempo: 5 years
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Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.
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5 years
|
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Rate of splenectomy in the cohort
Lasso di tempo: 5 years
|
5 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Bertrand GODEAU, MD, National Reference Center for Study of Cytopenia
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie ematologiche
- Emorragia
- Disturbi emorragici
- Disturbi della coagulazione del sangue
- Manifestazioni cutanee
- Disturbi delle piastrine del sangue
- Microangiopatie trombotiche
- Porpora
- Porpora, Trombocitopenica
- Porpora, Trombocitopenica, Idiopatica
- Trombocitopenia
Altri numeri di identificazione dello studio
- GECAI
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