Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA) (CONTENT)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Subcutaneous Anti-tnf-αlpha In Rheumatoid Arthritis: Analyze The Correlation Between Objective Measures Of Disease Activity And Safety And A Subjective Measure Such As Patient Beliefs About A Medicine|
- Correlation between patient beliefs about subcutaneous anti-TNF's Necessity and Disease Activity Score (DAS28) at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between Belief about Medicines Questionnaire (BMQ) Necessity and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between BMQ Concerns and DAS 28 at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Correlation between BMQ Concerns and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||February 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Rheumatoid arthritis patients treated with SC anti-TNF||
Other: SC anti-TNF
Subcutaneous (SC) anti-TNF
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432366
|Algemeen Ziekenhuis Sint Jan|
|Brugge, Belgium, 8000|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|