Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01727232
Enrollment
107
Registered
2012-11-15
Start date
2007-01-31
Completion date
2012-10-31
Last updated
2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Thrombocytopenia

Keywords

ITP, Rituximab, Efficacy, Anti-CD20, Regimen

Brief 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 .

Detailed 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.

Interventions

None listed

Sponsors

Henri Mondor University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary ITP * Age \> 18 years

Exclusion criteria

* Secondary ITP * Age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.one yearA 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/

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026