Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis
- Conditions
- Ambulatory IPF
- Registration Number
- NCT01969409
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Ambulatory patients with a diagnosis of IPF, not established >5 years from the enrollment<br>date, that fulfills American Thoracic Society (ATS)/European Thoracic Society (ETS)<br>Consensus Criteria.<br><br>Ability and willingness to give informed consent. Presence of autoantibodies against<br>Hepatoma-2 (HEp-2) cells, the assay for the primary endpoint.<br><br>Age 50-85 y.o.<br><br>Exclusion Criteria:<br><br>Diagnoses of current infection, proven or suspected by participating physicians based<br>upon their clinical assessments.<br><br>Presence of active hepatitis B or C, or HIV infection. Presence of positive CONVENTIONAL<br>autoimmune serologic tests, e.g., Antinuclear Antibodies (ANA), Rheumatoid Factor (RF),<br>Anti-Ro, Anti-LA, Anti-Ribonucleoprotein Antibodies (RNP), Anti-Jo-1.<br><br>History of reaction to murine-derived products or any of the trial medications, or prior<br>exposures to human-murine chimeric antibodies.<br><br>Malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer,<br>defined as stage T1 or T2a with Prostate-Specific Antigen (PSA) less than 10 ng/dl.<br><br>Unwillingness to complete post-treatment surveillance for 9 months. Diagnosis of major<br>morbidities (aside from IPF) expected to interfere with subjects' study participation for<br>9 months.<br><br>Treatment for >5 days within the preceding month with >10 mg. prednisone (or equivalent<br>corticosteroid) or any treatment during the preceding month with a potent cellular<br>immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine,<br>calcineurin inhibitors, etc.).<br><br>Uncontrolled diabetes or hypertension that preclude safe treatment with<br>methylprednisolone.<br><br>Concurrent participation in other experimental trials.<br><br>Pregnancy or unwillingness to use contraception during the duration of the study among<br>female participants with child-bearing potential.<br><br>Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) <70% of<br>predicted values.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Autoantibodies to Human Epidermoid (HEp)-2 Cells
- Secondary Outcome Measures
Name Time Method Changes in Anti-Heat Shock Protein 70 (HSP70) Autoantibodies;Changes in Forced Vital Capacity (FVC);Number of Adverse Events (AE);Number of Acute Exacerbations;Absolute Survival Percentage;Transplant-Free Survival;Hospitalizations