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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Val de Marne
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Creteil, Val de Marne, Frankrike, 94010
- Rekrytering
- Henri Mondor University Hospital
-
Kontakt:
- Mehdi KHELLAF, MD
- Telefonnummer: 0033149812076
- E-post: mehdi.khellaf@hmn.aphp.fr
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Underutredare:
- Mehdi KHELLAF, MD
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Creteil, Val de Marne, Frankrike, 94010
- Rekrytering
- National Reference Center for the Study of Auto Immune Cytopenia
-
Kontakt:
- Mehdi KHELLAF, MD
- Telefonnummer: 0033149812076
- E-post: mehdi.khellaf@hmn.aphp.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurrence of a serious adverse events (clinical or biological events)
Tidsram: 5 years
|
reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...
|
5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of rituximab on the natural history of ITP
Tidsram: 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
Tidsram: 5 years
|
number of perfusions, dosage, retreatment.
|
5 years
|
|
Characteristics of the patients receiving Rituximab
Tidsram: 5 years
|
age, sex, duration of ITP, previous used treatment
|
5 years
|
|
Evaluation of the Platelet count evolution
Tidsram: 5 years
|
Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.
|
5 years
|
|
Rate of splenectomy in the cohort
Tidsram: 5 years
|
5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Bertrand GODEAU, MD, National Reference Center for Study of Cytopenia
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Immunsystemets sjukdomar
- Autoimmuna sjukdomar
- Hematologiska sjukdomar
- Blödning
- Hemorragiska störningar
- Blodkoagulationsstörningar
- Hudmanifestationer
- Blodplättssjukdomar
- Trombotiska mikroangiopatier
- Purpura
- Purpura, trombocytopenisk
- Purpura, Trombocytopenisk, Idiopatisk
- Trombocytopeni
Andra studie-ID-nummer
- GECAI
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