A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
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.
|Idiopathic Pulmonary Fibrosis||Drug: Standard Steroid Treatment Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-Label, Phase II Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations|
- Reduction of autoantibody titers [ Time Frame: Baseline to Day 28 ]The primary end-point is reduction of autoantibody titers to cultured human primary pulmonary cells, comparing baseline measures of each individual to results of their measures on day 28, or the latest measure among patients who do not survive to day 28.
- IgG concentrations [ Time Frame: Baseline to Day 60 ]Treatment-related effects on plasma IgG concentrations
- B-cell counts [ Time Frame: Baseline to Day 60 ]
- Adverse event (AE) rates [ Time Frame: Baseline to Day 60 ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: Arm A - Standard Steroid Treatment||
Drug: Standard Steroid Treatment
One gm of methylprednisolone i.v., on day 0, followed by 40 mg/day i.v. on days 1-4, and days 6-12 (or the p.o. prednisone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone i.v. (or p.o. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the PI at each site.
|Experimental: Arm B - Experimental Treatment||
Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab
The Standard Steroid Treatment and, after insertion of a dialysis/apheresis catheter into a central vein, followed by initiation of the PEX and rituximab regimens.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524068
|United States, Pennsylvania|
|Geisinger Medical Center|
|Danville, Pennsylvania, United States, 17822|
|Temple University Medical Center|
|Philladelphia, Pennsylvania, United States, 19140|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University of Texas Medical Branch - Galveston|
|Galveston, Texas, United States, 77555|
|United States, Virginia|
|Inova Fairfax Heart and Vascular Institute|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Steven Duncan, MD||University of Pittsburgh|