A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations

Phase 2

Withdrawn

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: The Standard Steroid Treatment, Plasma Exchange and rituximab; Drug: Standard Steroid Treatment

• Registration Number: NCT01524068
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed Description

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 IPF exacerbations.

Study Timeline

• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Study Start: 2012-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B - Experimental Treatment	The Standard Steroid Treatment, Plasma Exchange and rituximab	-
Arm A - Standard Steroid Treatment	Standard Steroid Treatment	-

Primary Outcome Measures

Name	Time	Method
Reduction of autoantibody titers	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.

Secondary Outcome Measures

Name	Time	Method
IgG concentrations	Baseline to Day 60	Treatment-related effects on plasma IgG concentrations
B-cell counts	Baseline to Day 60
Adverse event (AE) rates	Baseline to Day 60

Trial Locations

Locations (5)

Temple University Medical Center; 🇺🇸 Philladelphia, Pennsylvania, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Inova Fairfax Heart and Vascular Institute; 🇺🇸 Falls Church, Virginia, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch - Galveston; 🇺🇸 Galveston, Texas, United States