Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT01432366
Brief Summary:
It can be assumed that there is a link between what the patient feels and thinks about his medication and objective measures of disease activity and safety.
Detailed Description:
A total of 500 subjects will provide 80% power to test the hypothesis that the absolute value of the correlation between two measures (e.g., BMQ Necessity and DAS28) is ≤ 0.3 (i.e., H0:│r│ ≤ 0.3 ) versus the alternative that it is \> 0.3 (i.e., H1:│r │ \> 0.3 ) assuming the absolute value of the true correlation is 0.40. A total of 500 will be enrolled to allow for approximately 5% being lost from analysis due to lack of post baseline data.
The Pearson method will be used for correlation between the BMQ total score for Necessity and the DAS28 and between the BMQ total score for Concern and DAS28. The Spearman rank method will be used for correlation between the BMQ total scores and Safety. For these latter analyses, subjects will be classified into one of 3 safety categories: (1) No AEs, (2) Non-serious AEs, (3) Serious AEs. 95% confidence intervals for the correlations will be provided.
Study:
NCT01432366
Study Brief:
Protocol Section:
NCT01432366