Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01969409|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Last Update Posted : February 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Ambulatory IPF||Drug: Rituximab Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis (ART-IPF)|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
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.
- Autoantibodies to Human Epidermoid (HEp)-2 Cells [ Time Frame: 9 months ]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 ]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 ]Serial FVC%p values over the observation period will be measured by spirometry.
- Adverse Event (AE) Rates [ Time Frame: 9 months ]AE in the two treatment arms will be compared.
- Acute exacerbation frequency [ Time Frame: 9 months ]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 ]Absolute and transplant-free survival in the two arms.
- Hospitalization rates [ Time Frame: 9 months ]The frequency and duration of hospitalizations in the two arms will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969409
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States|
|United States, Minnesota|
|University of Minnestoa|
|Minneapolis, Minnesota, United States|
|United States, Pennsylvania|
|Geisinger Medical Center|
|Danville, Pennsylvania, United States|
|Philadelphia, Pennsylvania, United States|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States|
|Principal Investigator:||Steven R Duncan, MD||University of Alabama at Birmingham|