Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)
Recent research studies have suggested that proteins called antibodies that are produced by the immune system might be involved in the lung damage of idiopathic pulmonary fibrosis (IPF). Antibodies produced by the immune system normal help to fight infections by attacking bacteria and viruses without harming our own tissues. In patients with IPF, there is evidence that certain antibodies (called autoantibodies) attack the lung and contributes to the injury and scarring that occurs in IPF. Our recent studies have found that many IPF patients appear to have excessive autoantibody levels in blood and lungs that might make their disease worse.
Rituximab is a medication approved by the Food and Drug Administration (FDA) for the treatment of autoantibody diseases such as rheumatoid arthritis. Rituximab works by destroying B cells, a type of white blood cell, called a B-lymphocyte, which produce autoantibodies. In this research study, rituximab will be given into a vein to reduce the autoantibody levels that we believe might be contributing to the lung damage in IPF.
This study is being conducted to determine if rituximab provides beneficial effects for IPF patients by decreasing further lung injury.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)|
- Autoantibodies to HEp-2 Cells [ Time Frame: 9 months ] [ Designated as safety issue: No ]Titers of anti-HEp-2 autoantibodies, by indirect immunofluorescence assays (IFA) over 9 months
- Anti-Heat Shock Protein 70 (HSP70) autoantibodies [ Time Frame: 9 months ] [ Designated as safety issue: No ]Changes of anti-HSP70 plasma concentrations as determined by ELISA
- Forced Vital Capacity (FVC) as a percentage of predicted values (FVC%p) [ Time Frame: 9 months ] [ Designated as safety issue: No ]Serial FVC%p values over the observation period will be measured by spirometry.
- Adverse Event (AE) Rates [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]AE in the two treatment arms will be compared.
- Acute exacerbation frequency [ Time Frame: 9 months ] [ Designated as safety issue: No ]The number and frequency of acute exacerbations, defined using consensus criteria (new/worsened hypoxemia and dyspnea, with characteristic radiographic changes within the last 30 days).
- Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]Absolute and transplant-free survival in the two arms.
- Hospitalization rates [ Time Frame: 9 months ] [ Designated as safety issue: No ]The frequency and duration of hospitalizations in the two arms will be compared.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.
Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable.
Other Name: Placebo (D5W) i.v.
Rituximab i.v. given on two occasions, with 14 days between doses.
i.v. rituximab given on two occasions 14 days apart.
This is a double-blinded, Phase II trial in which 58 ambulatory IPF patients at any of four medical centers (University of Pittsburgh, University of Chicago, Geisinger Medical Center, and Temple University) will be randomized equally to 1. placebo or 2. two doses of rituximab 1 gm i.v., with a 14 day interval inbetween doses.
Subjects will be followed for 9 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01969409
|Contact: Steven R Duncan, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Not yet recruiting|
|Chicago, Illinois, United States|
|United States, Pennsylvania|
|Geisinger Medical Center||Not yet recruiting|
|Danville, Pennsylvania, United States|
|Temple University||Not yet recruiting|
|Philadelphia, Pennsylvania, United States|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator: Danny Kass, MD|
|Principal Investigator:||Steven R Duncan, MD||University of Alabama at Birmingham|