J Rheumatol
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Randomized Controlled Trial Multicenter Study Clinical Trial
Intravenous human recombinant tumor necrosis factor receptor p55-Fc IgG1 fusion protein Ro 45-2081 (lenercept): a double blind, placebo controlled dose-finding study in rheumatoid arthritis.
To determine the optimal dose regimen for intravenous Ro 45-2081 (lenercept) in patients with rheumatoid arthritis (RA) by evaluating efficacy, safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics. ⋯ Intravenous Ro 45-2081 every 4 weeks proved to be well tolerated and transiently effective in the mid-dose group and modestly effective in the low and high dose groups in patients with longstanding RA. The interactions between Ro 45-2081, its non-neutralizing anti-Ro 45-2081 antibody, and the clinical benefit remain complex, but affected efficacy over the 12 weeks of treatment as Ro 45-2081 concentrations fell.
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Letters of information (LOI) for clinical trials are becoming longer and more complicated. We investigated patients' perspectives of their ability to understand the information presented during a clinical trial. Satisfaction with and motivation for participation in clinical trials were also ascertained. Perceptions from various treatment disciplines were compared. ⋯ Subjects reported that they were satisfied with the informed consent process and their experience in a clinical trial, and that they understood trial concepts. Subjects may be able to self-assess their own level of understanding for trial concepts that intrinsically make sense within the context of their beliefs about medical care, but other trial concepts may be misunderstood/misinterpreted regardless of self-assessment of understanding or education level (i.e., concealed allocation). Subjects may prefer to believe that investigators know which treatment they are receiving, and have made a good treatment decision specific to their case, despite having being told about concealed allocation and placebo use.