The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

— ITP-RITUX  

Official title:

The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01101295
• Other study ID #: GECAI
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2010
• Last updated: March 20, 2012
• Start date: April 2010
• Est. completion date: April 2017

Study information

• Verified date: March 2012
• Source: Henri Mondor University Hospital
• Contact: Bertrand GODEAU, MD
• Phone: 0033149812900
• Email: bertrand.godeau[@]hmn.aphp.fr
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2017
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Thrombocytopenia
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
France	Henri Mondor University Hospital	Creteil	Val de Marne
France	National Reference Center for the Study of Auto Immune Cytopenia	Creteil	Val de Marne

Sponsors (2)

Lead Sponsor	Collaborator
Henri Mondor University Hospital	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a serious adverse events (clinical or biological events)	reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...	5 years	Yes
Secondary	Impact of rituximab on the natural history of ITP	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	No
Secondary	Modality of the administration of rituximab	number of perfusions, dosage, retreatment.	5 years	No
Secondary	Characteristics of the patients receiving Rituximab	age, sex, duration of ITP, previous used treatment	5 years	No
Secondary	Evaluation of the Platelet count evolution	Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.	5 years	No
Secondary	Rate of splenectomy in the cohort		5 years	No