Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab

Autoimmune Diseases Clinical Trial

— PK-rituximab  

Official title:

Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820469
• Other study ID #: 07 140 03
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2009
• Last updated: May 10, 2017
• Start date: September 2008
• Est. completion date: January 2010

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Renal Transplant

Intervention

Drug:
• Rituximab 375
rituximab 375 mg/m2 IV weekly, during 4 weeks
• rituximab 1000
rituximab 1000 mg IV, two infusions on day 1 and day 15

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange		Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion
Secondary	Determination of amount rituximab eliminated during a plasma exchange		At each plasma exchange
Secondary	Evaluation of the efficacy of the treatment by CD19+B Cell count		15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion