Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis (PBC)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid|
- Biochemical Response [ Time Frame: Week 24 ]Normalization of alkaline phosphatase or decrease of alkaline phosphatase by > 40% of the Day 0 level at 24 weeks of treatment.
- Safety [ Time Frame: Weeks 2, 4, 12, 24, and 36 ]Safety outcomes include adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug.
- Absolute and percent change in alkaline phosphatase [ Time Frame: Week 24 ]The absolute and percent change in alkaline phosphatase from Day 0 to Week 24.
- Absolute and percent change in alanine transferase (ALT) [ Time Frame: Week 24 ]The absolute and percent change in alanine transferase (ALT) from Day 0 to Week 24.
- Liver stiffness measured by magnetic resonance elastography [ Time Frame: Week 24 ]Change in liver stiffness measured by magnetic resonance elastography from Day 0 to Week 24.
- Quality of life [ Time Frame: Week 24 ]Change in quality of life measured by change in PBC-40 from Day 0 to Week 24.
- Anti-abatacept titers [ Time Frame: Week 24 ]Frequency and titer of anti-abatacept antibody at Day 0 and Week 24
- Abatacept levels [ Time Frame: Weeks 0, 4, 12, 24, and 36 ]Trough levels of abatacept at Day 0 and Weeks 4, 12, 24, and 36.
- Anti-mitochondrial antibody titers [ Time Frame: Week 24 ]Change in anti-mitochondrial antibody titers form Day 0 to Week 24.
- Immunoglobulin M (IgM) Levels [ Time Frame: Week 24 ]Change in IgM level from Day 0 to Week 24
- Memory T cell frequencies [ Time Frame: Week 24 ]Change in cluster of differentiation 4 (CD4)+ cluster of differentiation 44 (CD44)+ cluster of differentiation 62 ligand (CD62L)- and cluster of differentiation 8+ CD44+ CD62L- frequencies in peripheral blood mononuclear cells from Day 0 to Week 24
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Abatacept 125 mg weekly
Open label treatment with Abatacept
125 mg subcutaneously each week for 24 weeks
Other Name: Orencia
This is an open label, active treatment trial to assess the efficacy and safety of abatacept in subject with PBC who have had an incomplete biochemical response to UDCA. In this trial, 20 subjects with PBC who have had an incomplete biochemical response to UDCA will be assigned to treatment with weekly subcutaneous injections of 125 mg of abatacept. The treatment phase of the study will last 24 weeks with an off-treatment follow up at Week 36.
Inclusion criteria include:
- Confirmed diagnosis of PBC
- Alkaline phosphatase > 1.67 times the upper limit of normal after 6 months of treatment with UDCA
Please refer to this study by its ClinicalTrials.gov identifier: NCT02078882
|United States, California|
|Univeristy of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Christopher L Bowlus, MD||University of California, Davis|
|Principal Investigator:||M. Eric Gershwin, MD||University of California, Davis|