Purpura, Thrombocytopenic, Idiopathic Clinical Trial
Official title:
The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01356511 -
High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
|
Phase 4 | |
| Completed |
NCT00540423 -
Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00372892 -
Pilot Study of Rituximab for the Treatment of Acute Immune Thrombocytopenic Purpura (ITP)
|
Phase 2 | |
| Not yet recruiting |
NCT03252457 -
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
|
Phase 3 | |
| Completed |
NCT00151840 -
Efficacy and Safety of IVIG-L in ITP Patients
|
Phase 3 | |
| Recruiting |
NCT05438875 -
The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9
|
Phase 3 | |
| Completed |
NCT02281370 -
Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects
|
Phase 1 | |
| Terminated |
NCT00547066 -
Study of Veltuzumab (hA20) at Different Doses in Patients With ITP
|
Phase 1/Phase 2 | |
| Completed |
NCT00370331 -
RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
|
Phase 3 | |
| Completed |
NCT00828750 -
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00487968 -
Eltrombopag Taste Testing in Healthy Adult Volunteers
|
Phase 1 | |
| Withdrawn |
NCT01317966 -
Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia
|
N/A | |
| Not yet recruiting |
NCT03443570 -
Rituximab Combining Bortezomib Versus Rituximab in Management of ITP
|
Phase 3 | |
| Completed |
NCT01610180 -
Eltrombopag for the Treatment of Immune ThrombocytoPenia (ITP) Secondary to Chronic Lymphoproliferative Disorders (LPDs)
|
Phase 2 | |
| Completed |
NCT02201290 -
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00220727 -
Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP
|
Phase 2 | |
| Completed |
NCT02334813 -
Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
|
Phase 3 | |
| Completed |
NCT02891109 -
Regulatory B Cells and Chronic Immune Thrombocytopenia
|
N/A | |
| Completed |
NCT00706342 -
Pilot Study of be Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)
|
Phase 2 | |
| Completed |
NCT03258866 -
The Study of Different Dose Rituximab in the Treatment of ITP
|
Phase 4 |