Asthma Clinical Trial
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
The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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