Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia

Primary Immune Thrombocytopenia Clinical Trial

Official title:

Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727232
• Other study ID #: Mondor-Rituxcompare
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 12, 2012
• Start date: January 2007
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Observational

Clinical Trial Summary

The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .

Description:

Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary ITP

• Age > 18 years

Exclusion Criteria:

• Secondary ITP

• Age < 18 years

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henri Mondor University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.	A complete response (CR) was defined as a platelet count >100 x 109/l and a response (R): by a platelet count >30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/	one year	Yes
Secondary	The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.		3 months, one year, last follow-up	Yes