Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis

Conditions

• Ambulatory IPF

Eligibility Criteria

Sex

ALL

Age

50 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  i.v. rituximab given on two occasions 14 days apart.
• Placebo — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 31, 2014

Status verified

Aug 2024

Primary completion

Jan 31, 2019

Completion

Nov 30, 2020

Study Design

Enrollment

58 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  These subjects will receive i.v. placebo (5% dextrose in water) administered identically to the rituximab.
• Experimental: Rituximab
  Rituximab i.v. given on two occasions, with 14 days between doses.

Primary Outcome Measure

Autoantibodies to Human Epidermoid (HEp)-2 Cells [ Time Frame: baseline to 9 months ]

Locations (7)

Find similar trials in Birmingham, AL