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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00675649 |
The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Biological: CNTO 148 / Golimumab Biological: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study Evaluating the Efficacy and Safety of Golimumab Administered Subcutaneously in Symptomatic Subjects With Severe, Persistent Asthma |
Estimated Enrollment: | 200 |
Estimated Study Completion Date: | October 2010 |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Biological: CNTO 148 / Golimumab
100 mg sc injection every 4 weeks from week 0 to week 20
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002: Placebo Comparator |
Biological: placebo
placebo sc injection every 4 weeks from week 0 to week 20
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Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of severe, persistent asthma.This study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. The effect of subcutaneously (SC) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. About 200 patients will take part in the study at approximately 60 centers worldwide. Participation in the study will last for about 42 weeks. The study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). Visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. Patients eligible to take part in this study will be randomly placed into one of the following study groups: Group 1: Placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from Week 0 through Week 20. Group 2: Golimumab 100 mg from Week 0 through Week 20. This study is "blinded." This means that neither patient nor study doctor will know in which group a patient is placed. However, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time.
Patients will receive an injection (under the skin) of placebo (Group 1) or golimumab 100 mg (Group 2) every 4 weeks from Week 0 through Week 20.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Centocor, Inc. ( Director of Clinical Research ) |
Study ID Numbers: | CR014980, C0524T26, EudraCT No.: 2007-005699-15 |
Study First Received: | May 8, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00675649 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Injections Severe, persistent asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |