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
This study has been completed.
Sponsor:
Henri Mondor University Hospital
Information provided by (Responsible Party):
Dr Mahévas Matthieu, MD, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01727232
First received: November 12, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
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Purpose
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 .
| Condition |
|---|
|
Primary Immune Thrombocytopenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Henri Mondor University Hospital:
Primary Outcome Measures:
- The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. [ Time Frame: one year ] [ Designated as safety issue: Yes ]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/
Secondary Outcome Measures:
- The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response. [ Time Frame: 3 months, one year, last follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 107 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Standard regimen
Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab
|
|
Rheumatoid arthritis regimen
Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.
Criteria
Inclusion Criteria:
- Primary ITP
- Age > 18 years
Exclusion Criteria:
- Secondary ITP
- Age < 18 years
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr Mahévas Matthieu, MD, MD, Henri Mondor University Hospital |
| ClinicalTrials.gov Identifier: | NCT01727232 History of Changes |
| Other Study ID Numbers: | Mondor-Rituxcompare |
| Study First Received: | November 12, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences |
Keywords provided by Henri Mondor University Hospital:
|
ITP Rituximab Efficacy Anti-CD20 Regimen |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Rituximab Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 13, 2013