Treatment with Infliximab plus Methotrexate Improves Anemia in Patients with Rheumatoid Arthritis Independent of Improvement in Other Clinical Outcome Measures—A Pooled Analysis from Three Large, Multicenter, Double-Blind, Randomized Clinical Trials

2009 ◽  
Vol 39 (2) ◽  
pp. 123-131 ◽  
Author(s):  
Mittie K. Doyle ◽  
Mahboob U. Rahman ◽  
Chenglong Han ◽  
John Han ◽  
Jon Giles ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Clinical Outcome ◽  
Outcome Measures ◽  
Randomized Clinical Trials ◽  
Pooled Analysis ◽  
Double Blind

scholarly journals Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data

2020 ◽  
Author(s):  
Teresa A Simon ◽  
Lixian Dong ◽  
Kevin L. Winthrop
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Herpes Zoster ◽  
Opportunistic Infections ◽  
Clinical Trial Data ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind

Abstract Background: To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials.Methods: This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated. Results: In cumulative periods, 7044 patients received abatacept, with a mean (standard deviation) duration of exposure of 36.9 (26.2) months (21,274 patient-years of exposure). IRs (95% CIs) of OIs were 0.17 (0.05–0.43) for abatacept and 0.56 (0.22–1.15) for placebo during the controlled periods and 0.21 (0.15–0.28) for abatacept during the cumulative periods. There was 1 case of tuberculosis in both the abatacept (IR [95% CI]: 0.04 [0.00–0.24]) and placebo (IR [95% CI]: 0.08 [0.00–0.44]) groups during the controlled periods; 13 verified tuberculosis cases (IR [95% CI]: 0.06 [0.03–0.10]) were reported in the cumulative period. Herpes zoster was reported numerically more often with abatacept (IR 1.9 [1.4–2.5]), versus placebo (1.7 [1.1–2.6]) in the controlled periods; within the cumulative period, herpes zoster IR (95% CI) was 1.53 (1.36–1.71) for abatacept-treated patients.Conclusion: In controlled periods of the clinical trials, abatacept-treated patients had similarly low rates of OIs compared with placebo-treated patients. Overall, OI rates were similar among abatacept-treated patients in the controlled and cumulative periods and consistent with the ranges reported in the literature.

scholarly journals Biphasic feature of placebo response in primary insomnia: pooled analysis of data from randomized controlled clinical trials of orexin receptor antagonists

SLEEP ◽  
2019 ◽  
Vol 43 (3) ◽  
Author(s):  
Dongmei He ◽  
Binghu Jiang ◽  
Zhiwei Guo ◽  
Qiwen Mu ◽  
Morgan A Mcclure
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Placebo Response ◽  
Pooled Analysis ◽  
Primary Insomnia ◽  
Subjective Measures ◽  
Receptor Antagonists ◽  
Double Blind

Abstract Objectives The placebo response to orexin receptor antagonists in primary insomnia is little-known. Our aim was, therefore, to conduct a systematic review of placebo-controlled randomized clinical trials to characterize placebo response. Methods We performed a comprehensive literature search for randomized, placebo-controlled, double-blind clinical trials evaluating the efficacy of orexin receptor antagonists addressing primary insomnia. To pool effect size estimates (Cohen’s d) of placebo and orexin receptor antagonists across trials for outcome measures, a meta-analysis was done according to the Cochrane guideline. Results The placebo response was significant and robust to improve the symptoms of insomnia in terms of objective and subjective measures, and the effects (0.70 ± 0.51) in subjective measures were smaller than that (1.10 ± 1.14) in objective measures (p = 0.027). The biphasic feature of placebo response showed an initial short-term increase of placebo effect and subsequent changeless long-term effect. Conclusion The biphasic feature of placebo response is clinically useful, and neuroimaging is essential to clarify the long-term mechanism in the future.

scholarly journals Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data

2020 ◽  
Author(s):  
Teresa A Simon ◽  
Lixian Dong ◽  
Kevin L. Winthrop
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Herpes Zoster ◽  
Opportunistic Infections ◽  
Clinical Trial Data ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind

Abstract Background: To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials.Methods: This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated. Results: In cumulative periods, 7,044 patients received abatacept, with mean (standard deviation) duration of exposure of 36.9 (26.2) months (21,274 patient-years of exposure). IRs (95% CI) of OIs for abatacept were low in both controlled (0.17 [0.05–0.43]), placebo (0.56 [0.22–1.15]), and cumulative (0.21 [0.15–0.28]) periods. There was 1 case of tuberculosis in both the abatacept (IR [95% CI]: 0.04 [0.00-0.24]) and placebo (IR [95% CI]: 0.08 [0.00-0.44]) groups during the controlled periods; 16 verified tuberculosis cases (IR [95% CI]: 0.08 [0.05-0.12]) were reported in the cumulative period. Herpes zoster was reported numerically more often with abatacept (IR 1.9 [1.4–2.5]), versus placebo (1.7 [1.1–2.6]) in the controlled periods; within the cumulative period, herpes zoster IR (95% CI) was 1.53 (1.36–1.71) for abatacept-treated patients.Conclusion: In controlled periods of the clinical trials, abatacept-treated patients had similarly low rates of OIs compared with placebo-treated patients. Overall, OI rates were similar among abatacept-treated patients in the controlled and cumulative periods.

scholarly journals Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data

2020 ◽  
Author(s):  
Teresa A Simon ◽  
Lixian Dong ◽  
Kevin L. Winthrop
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Herpes Zoster ◽  
Opportunistic Infections ◽  
Clinical Trial Data ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Placebo Control ◽  
Open Label ◽  
Double Blind

Abstract Background : To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials. Methods : This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated. Results : In cumulative periods, 7,044 patients received abatacept, with mean (standard deviation) duration of exposure of 36.9 (26.2) months (21,335 patient-years of exposure). IRs (95% CI) of OIs for abatacept were low in both controlled (0.17 [0.05–0.43]), placebo (0.56 [0.22–1.15]), and cumulative (0.21 [0.15–0.28]) periods. There was 1 case of tuberculosis in both the abatacept (IR [95% CI]: 0.04 [0.00-0.24]) and placebo (IR [95% CI]: 0.08 [0.00-0.44]) groups during the controlled periods; 16 verified tuberculosis cases (IR [95% CI]: 0.08 [0.05-0.12]) were reported in the cumulative period. Herpes zoster was reported numerically more often with abatacept (IR 1.9 [1.4–2.5]), versus placebo (1.7 [1.1–2.6]) in the controlled periods; within the cumulative period, herpes zoster IR (95% CI) was 1.53 (1.36–1.71) for abatacept-treated patients. Conclusion : In controlled periods of the clinical trials, abatacept-treated patients had similarly low rates of OIs compared with placebo-treated patients. Overall, OI rates were similar among abatacept-treated patients in the controlled and cumulative periods.

scholarly journals Agonist-Like or Antagonist-Like Treatment for Cocaine Dependence with Methadone for Heroin Dependence: Two Double-Blind Randomized Clinical Trials

2003 ◽  
Vol 29 (5) ◽  
pp. 969-981 ◽  
Author(s):  
John Grabowski ◽  
Howard Rhoades ◽  
Angela Stotts ◽  
Katherine Cowan ◽  
Charles Kopecky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Cocaine Dependence ◽  
Heroin Dependence ◽  
Double Blind

What are the reciprocal influences of randomized clinical trials and the patient–psychiatrist relationship?

1999 ◽  
Vol 14 (2) ◽  
pp. 93-100
Author(s):  
J. Catteau ◽  
C. Cyran ◽  
R. Bordet ◽  
C.E. Thomas ◽  
B.A. Dupuis
Keyword(s):  
Clinical Trials ◽  
Depressive Disorders ◽  
Randomized Clinical Trials ◽  
Antidepressant Drugs ◽  
Antidepressant Medication ◽  
Study Data ◽  
Phase Iii ◽  
Double Blind ◽  
Phase Iii Clinical Trials ◽  
Reciprocal Influences

SummaryThe goal of this prospective investigation was to study the course and the quality of patient-psychiatrist relationships during phase II / phase III clinical trials of antidepressant medication prescribed for depressive disorders. All patients who participated in the clinical trials (and subsequently in this survey) signed written informed consent statements and were subject to random double blind treatment assignment. Retrospective analysis of 118 investigations was carried out, and the patients involved were questioned concerning their experiences and impressions during and after the study. Data show that the outcome of clinical trials of antidepressant drugs are not a function of pre-existing good patient-psychiatrist relationships. On the other hand, no effects on the patient-psychiatrist relationship were found as a result of the experimental procedure, and it can be concluded that no detrimental effects on future patient-psychiatrist relationships were incurred.

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