A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
Status:
Withdrawn
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, multi-center, open-label Phase II clinical trial to determine the
efficacy of combined plasma exchange (PEX), rituximab, and conventional corticosteroid
administration, in comparison to corticosteroids alone, among patients with acute Idiopathic
Pulmonary Fibrosis (IPF) exacerbations.
The investigators central hypothesis is that antibody-mediated autoimmunity can play an
important role in IPF exacerbations. The investigators propose to test our central hypothesis
by establishing the efficacy of autoantibody removal by plasma exchange (PEX), in conjunction
with B-cell depletion by rituximab to deplete immunoglobulins and minimize their further
production, among patients with acute IPF exacerbations.
The primary goal of this randomized, multi-center, open-label Phase II clinical trial is to
determine effects of combined plasma exchange (PEX), rituximab, and conventional
corticosteroid administration on selected, relevant immunological parameters, in comparison
to effects of steroids alone, among AE-IPF patients. The investigators anticipate the
findings of this will lead to larger incremental trial(s) to determine actual clinical
efficacy of this treatment.
A total of 40 subjects will be enrolled in this multi-center trial from 5 participating
medical centers.