Primary Biliary Cirrhosis Clinical Trial
Official title:
Effects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with PBC, a disease of the immune system. However, the safety of rituximab in PBC patients must first be established.
This is a pilot, open-label, study on 10 female patients with AMA-positive PBC to determine
the effects of two infusions of rituximab on response of memory B cells to bacterial motifs,
on biochemical function, and histological features. We will enroll 10 consecutive
AMA-positive patients with the diagnosis of PBC based on internationally accepted criteria
and histological staging determined at liver biopsy and being currently treated with UDCA.
Importantly, patients with advanced histological stages, decompensated liver disease, or
waiting for OLT will not be included in the study (see exclusion criteria).
Patients eligible and willing to enter the study will be evaluated at baseline by isolation
and study of frequency and absolute numbers of B cells and their function, biochemical and
AMA tests. Histology and quality of life will be also evaluated in all patients. The
methodology to be used for B cell study is already well-established in our laboratory as can
be seen in the attached paper (Kikuchi et al. 2005b). Patients will be administered 1,000 mg
rituximab intravenously by slow infusion on Day 1 and Day 15 (+/- 1 day). Rituximab's
pharmacokinetics indicate that complete B cell depletion is obtained 2-3 days after
administration and that such effect may be lost after 9 months (Vieira et al. 2004). In
addition to our B cell work, serum samples will undergo AMA testing, including titers, using
recombinant mitochondrial antigens (Miyakawa et al. 2001). Patients will also undergo serum
chemistry panel, which includes liver function tests. Patients will continue on a steady
dose of UDCA therapy throughout the study.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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