A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
The experimental drug CNTO 888 is currently being studied in cancer patients with solid tumors and this study is the first to use this drug for patients with idiopathic pulmonary fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effects (good and bad) on patients with IPF. The study will be conducted at approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF while enrolled in the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.
This study tests the safety and effectiveness of an experimental drug, CNTO 888, compared to placebo. The purpose of this research study is to determine if CNTO 888 is safe and to determine its effects on patients with idiopathic pulmonary fibrosis (IPF). CNTO 888 has not been approved by any regulatory authority for use in patients with any condition. The screening phase of the study, where the study doctor will determine if a patient is eligible for the study will last for 1 to 4 weeks. The study will enroll and treat the first 20 patients as part of a safety evaluation, at selected sites. The patients will be randomized to placebo or 1 mg/kg or 5 mg/kg or 15 mg/kg CNTO 888. The study drug will be given through a needle inserted into the patient's vein (IV). A Data Monitoring Committee will be responsible to review this portion of the study, and the study in general. They will review all of the information from patients in this portion of the study, after patients have received three infusions of study agent, or 3 months have passed since the first patient was enrolled. After their review, they will recommend whether to continue enrolling additional patients for the remainder of the study, or require some modification to the study. Patients will receive study agent until Week 48 and will continue to be followed through Week 72 for assessment of safety and any other effects after discontinuation of therapy. Patients will be in the study for about 74 weeks. The end of the study is defined as the last visit of the last patient. Patients will be randomly assigned to 1 of 4 treatment groups. Group 1, placebo IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 2, CNTO 888 1 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 3, CNTO 888 5 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Group 4, CNTO 888 15 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48. Enrollment completed as planned. Dosing terminated after interim DMC (Data Monitoring Committee) review. Subjects followed until trial completed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Placebo, CNTO 888 1 mg/kg, CNTO 888 5 mg/kg, CNTO 888 15 mg/kg
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00786201
- Information obtained from ClinicalTrials.gov on January 23, 2013
Medical and Biotech [MESH] Definitions
A group of interstitial lung diseases with no known etiology. There are several entities with varying patterns of inflammation and fibrosis. They are classified by their distinct clinical-radiological-pathological features and prognosis. They include IDIOPATHIC PULMONARY FIBROSIS; CRYPTOGENIC ORGANIZING PNEUMONIA; and others.
A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.
A common interstitial lung disease of unknown etiology, usually occurring between 50-70 years of age. Clinically, it is characterized by an insidious onset of breathlessness with exertion and a nonproductive cough, leading to progressive DYSPNEA. Pathological features show scant interstitial inflammation, patchy collagen fibrosis, prominent fibroblast proliferation foci, and microscopic honeycomb change.
A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.
Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.
The purpose of this study is to assess the effectiveness and safety of CNTO 1275 in patients with moderate to severe plaque type psoriasis in subcutaneous administration of 45 and 90 mg at...
The purpose of this study is to determine if CNTO 888 is safe and to determine how long CNTO 888 stays in the body and what effects it might have on cancer tumors.
The purpose of Part 1 of the study is to determine the safety of the combination of CNTO 328 and bortezomib. The purpose of Part 2 of the study is to compare the length of progression fre...
The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of doceta...
The purpose of this research study is to find out what side effects the combination of the two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the highest...
Pulmonary fibrosis occurs due to fibroblast proliferation and collagen production in the lung and begins with alveolar inflammatory edema. Aquaporins (AQPs) play pivotal roles in lung fluid transport....
In cystic fibrosis (CF), systemic inflammation and pulmonary infections sustain a catabolic response leading to fat free mass (FFM) depletion.
Pulmonary fibrosis is a rare and progressive lung disease with a high mortality rate. The treatment regimens still fail to recover the disease. Leflunomide (LEF) is an immunomodulatory agent with anti...
Pulmonary hypertension is frequently observed in advanced idiopathic pulmonary fibrosis (IPF) and is associated with poor prognosis. Cardiopulmonary exercise testing (CPET) can be used to detect less...
Idiopathic pulmonary fibrosis (IPF) is a relentless, fibrotic parenchymal lung disease in which alternatively programmed macrophages produce pro-fibrotic molecules that promote myofibroblast survival...