The Efficacy And Safety Of Cnto 148

1302 Words6 Pages
According to (2013a), the official title for this report is A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects with Severe Persistent Asthma. The purpose of this study is to assess if the CNTO 148 (golimumab) drug administered via injection had a profound effect in treating patients suffering from severe persistent asthma and to ascertain if it was safe. This study was an interventional Phase 2 clinical trial comprising a multicenter, randomized, double-blind trial where both the physician and the patient were unaware if the placebo or the CNTO 148 drug was given. In addition, this interventional trial involved parallel-groups in which every single group were treated at the exact time and received the same dosage regardless if it was the CNTO 148 drug or the placebo. To evaluate this interventional study, the steroid stable phase occurred in the first 24 weeks of treatment where the patients receive stable doses of the concomitant corticosteroids (CS) medication. Next, the taper phase ensues for 28 weeks where the patients receive a lower dosage of the concomitant CS medications. “Patients will receive subcutaneous injections of 75, 150, or 300 mg of CNTO 148 or placebo every 4 weeks for 52 weeks followed by 50, 100, or 200 mg every 4 weeks through week 52” (, 2013a). Once the study treatment is concluded, the patients are followed for an additional 24 weeks to assess the consequences of the medications. Safety is a high priority for the effects of this CNTO 148 drug. Therefore, it was imperative that patients are continuously observed during a... ... middle of paper ... ...nd the CNTO 148 groups. However, side effects were direr in the CNTO 148 group. One death and all eight malignancies befell in the active groups (Wenzel et al., 2009). This study was valuable. It helped to discover the danger of using this drug to treat asthma patients. Without this knowledge, if clinicians provided this drug to their patients with severe asthma then several of these patients could die. Despite this negative result, this drug is of value to treat other conditions such as rheumatoid arthritis and ankylosing spondylitis. For instance, it was shown in a study with 356 subjects that treatment with golimumab reduced signs and symptoms of Ankylosing spondylitis in 59-60% patients by week 14 compared to only 22% of patients in the placebo group. (Mazumdar & Greenwald, 2009). Every drug may have a specific for a specific condition if used in minute amounts.

    More about The Efficacy And Safety Of Cnto 148

      Open Document