Purpura, Thrombocytopenic, Idiopathic | The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.
Purpura, Thrombocytopenic, Idiopathic research study
What is the primary objective of this study?
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
Who is eligible to participate?
- ITP diagnosis according to the American Society of Hematology society
- Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)
- Previous treatment by rituximab
- Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia,
- Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Purpura, Thrombocytopenic, Idiopathic
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2010
Completed Date: April 2017
Primary Outcome: Occurrence of a serious adverse events (clinical or biological events)
Secondary Outcome: Impact of rituximab on the natural history of ITP
Study sponsors, principal investigator, and references
Principal Investigator: Bertrand GODEAU, MD
Lead Sponsor: Henri Mondor University Hospital
Collaborator: Roche Pharma AG