A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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| ClinicalTrials.gov Identifier: NCT00786201 |
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Recruitment Status :
Completed
First Posted : November 6, 2008
Last Update Posted : December 28, 2015
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Sponsor:
Centocor, Inc.
Information provided by (Responsible Party):
Centocor, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Fibrosis | Drug: Placebo Drug: CNTO 888 1 mg/kg Drug: CNTO 888 5 mg/kg Drug: CNTO 888 15 mg/kg | Phase 2 |
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. Participants followed until trial completed.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 126 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects With Idiopathic Pulmonary Fibrosis |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | January 2012 |
| Actual Study Completion Date : | January 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Idiopathic pulmonary fibrosis
MedlinePlus related topics:
Pulmonary Fibrosis
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48 |
| Experimental: CNTO 888 1 mg/kg |
Drug: CNTO 888 1 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48 |
| Experimental: CNTO 888 5 mg/kg |
Drug: CNTO 888 5 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48 |
| Experimental: CNTO 888 15 mg/kg |
Drug: CNTO 888 15 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48 |
Primary Outcome Measures :
- Rate of Percent Change (Relative to Baseline per 4 Week Interval) in Forced Vital Capacity (FVC) Through Week 52 [ Time Frame: Baseline through Week 52 ]The FVC is one component of pulmonary function testing, done with a spirometer.
Secondary Outcome Measures :
- Time to Disease Progression [ Time Frame: Baseline through Week 52 ]The time to disease progression is defined as the time in days from randomization to occurrence of acute idiopathic pulmonary fibrosis (IPF) exacerbation or lung transplantation or all-cause mortality, whichever occurs first.
- Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 52 [ Time Frame: Baseline through Week 52 ]The FVC is one component of pulmonary function testing, done with a spirometer.
- Relative Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52 [ Time Frame: Baseline through Week 52 ]The DLCO is a sensitive lung function parameter and is performed to determine how well oxygen passes from the air sacs of the lungs into the blood.
- Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 [ Time Frame: Baseline through Week 52 ]The SGRQ is a 76-item questionnaire designed to measure the impact of respiratory disease and its treatment on the participants' health outcomes. The SGRQ is divided into 3 components: 1) symptoms, 2) activity limitations and 3) Impacts on social and psychological functioning.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Forced Vital Capacity (FVC) >= (greater than or equal to) 50% of the predicted value at screening
- Abnormal lung function test results that include evidence of restriction and impaired gas exchange, or evidence of desaturation at rest or exercise or decreased diffusing capacity of the lung for carbon monoxide (DLCO)
- Bibasilar reticular abnormalities with minimal ground-glass opacities on high-resolution computed tomography (HRCT) scans
- Have surgical lung biopsy evidence of usual interstitial pneumonia (UIP) and/or HRCT scan-based diagnosis of IPF
- Relative decrease of >= 10% in forced vital capacity (FVC), or relative decrease of >= 15% in DLCO, or evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities), or significant worsening of dyspnea at rest or with exertion.
Exclusion Criteria:
- Have evidence of interstitial pneumonia other than IPF
- Diagnosis of IPF is not confirmed by HRCT or lung biopsy results
- Partial pressure of oxygen in arterial blood (PaO2) < 55 mmHg (sea level) or 50 mmHg (altitude) at rest on room air
- Have a diagnosis of other significant respiratory disorder (eg, asthma, tuberculosis (TB), sarcoidosis, aspergillosis, chronic obstructive pulmonary disease [COPD], or cystic fibrosis)
- Have obstruction on prebronchodilator pulmonary function tests (PFTs) (defined as FEV1/FVC < 0.7) at screening or demonstrate an increase in FEV1 >= 12% postbronchodilator.
Information from the National Library of Medicine
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): NCT00786201
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| Tampa, Florida, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Kansas | |
| Wichita, Kansas, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| Spartanburg, South Carolina, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| United States, Utah | |
| Salt Lake City, Utah, United States | |
| United States, Vermont | |
| Colchester, Vermont, United States | |
| Belgium | |
| Leuven, Belgium | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada | |
| London, Ontario, Canada | |
| Canada | |
| Vancouver, Canada | |
| Germany | |
| Bad Berka, Germany | |
| Essen, Germany | |
| Netherlands | |
| Amsterdam, Netherlands | |
| Nieuwegein, Netherlands | |
| Rotterdam, Netherlands | |
| Sittard, Netherlands | |
Sponsors and Collaborators
Centocor, Inc.
Investigators
| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Publications of Results:
| Responsible Party: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00786201 |
| Other Study ID Numbers: |
CR015235 CNTO888PUL2001 ( Other Identifier: Centocor ) |
| First Posted: | November 6, 2008 Key Record Dates |
| Last Update Posted: | December 28, 2015 |
| Last Verified: | November 2015 |
Keywords provided by Centocor, Inc.:
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CNTO 888 Idiopathic Pulmonary Fibrosis IPF |
Additional relevant MeSH terms:
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases |
Respiratory Tract Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |