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

Part of paid clinical trials in Danville, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT01524068
Phase
PHASE2
Status
Withdrawn

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Steroid Treatment — DRUG
    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.
  • The Standard Steroid Treatment, Plasma Exchange and rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2012
Status verified
Jan 2016
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Standard Steroid Treatment
  • Experimental: Arm B - Experimental Treatment

Primary Outcome Measure

Reduction of autoantibody titers [ Time Frame: Baseline to Day 28 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Geisinger Medical CenterDanvillePennsylvania17822-
Temple University Medical CenterPhilladelphiaPennsylvania19140-
University of PittsburghPittsburghPennsylvania15213-
University of Texas Medical Branch - GalvestonGalvestonTexas77555-
Inova Fairfax Heart and Vascular InstituteFalls ChurchVirginia22042-

Find similar trials in Danville, PA

By research site
Geisinger Medical Center· Danville, PATemple University Medical Center· Philladelphia, PAUniversity of Pittsburgh· Pittsburgh, PAUniversity of Texas Medical Branch - Galveston· Galveston, TXInova Fairfax Heart and Vascular Institute· Falls Church, VA

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