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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014