Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab (PK-rituximab)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00820469
First received: January 9, 2009
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.

The aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.

The results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.


Condition Intervention Phase
Humoral Acute Refection of Renal Transplant
Autoimmune Diseases
Drug: Rituximab 375
Drug: rituximab 1000
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange [ Time Frame: Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of amount rituximab eliminated during a plasma exchange [ Time Frame: At each plasma exchange ] [ Designated as safety issue: No ]
  • Evaluation of the efficacy of the treatment by CD19+B Cell count [ Time Frame: 15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients treated by rituximab
Drug: Rituximab 375
rituximab 375 mg/m2 IV weekly, during 4 weeks
Experimental: 2
Patients treated by rituximab and plasma exchange
Drug: rituximab 1000
rituximab 1000 mg IV, two infusions on day 1 and day 15

Detailed Description:

Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.

The enrollment in the study will not change the treatment of patients except for blood sampling.

Each patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.

The plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.

The AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant
  • Patient older than 18 years old
  • Patient who have signed the written informed consent form

Exclusion Criteria:

  • Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))
  • Blood sampling impossibility
  • Pregnant or breasting women
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820469

Locations
France
University Hospital Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jacques Pourrat, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: LLAU ME, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00820469     History of Changes
Other Study ID Numbers: 0714003
Study First Received: January 9, 2009
Last Updated: March 4, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Rituximab
Plasma exchange
Autoimmune diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 27, 2014